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This document summarizes a presentation on medication-assisted treatment for opioid addiction. It discusses the history of treatment approaches, including the development of methadone and buprenorphine maintenance therapies. Studies show that agonist therapies like methadone and buprenorphine are more effective at retaining patients in treatment and reducing illicit opioid use than non-medication approaches. While both methadone and buprenorphine are effective, buprenorphine has a safer side effect profile but its effectiveness may be limited by lower monitoring and adherence compared to methadone treatment. The document reviews several studies demonstrating the benefits of long-term agonist therapy over detoxification or short-term medication approaches for opioid

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Medication-Assisted Treatment Presenters: • Adam Bisaga, MD, Professor of Psychiatry, Columbia University Medical Center • Phillip Walls, RPh, Chief Clinical Officer, myMatrixx • Michael Coupland, MA, RPsych, Network Medical Director, IMCS Group • Robert L. DuPont, MD, Founding President, Institute for Behavior and Health, Inc. • Katherine Garcia-Rosales, BS, Research Assistant, Center for Substance Abuse Research, University of Maryland College Park Pre-Summit Workshop Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA, President- elect, American Society of Addiction Medicine, and Member, Rx and Heroin Summit National Advisory Board
Disclosures • Michael Coupland, MA, RPsych; Katherine Garcia-Rosales, BS; and Kelly J. Clark, MD, MBA, FASAM, DFAPA, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services. • Adam Bisaga, MD – Contracted Research: Alkermes • Robert DuPont – Employment: Bensinger, DuPont & Associates-Prescription Drug Research Center • Phillip Walls, RPh – Employment and ownership interest: Matrix HCS, Inc.
Disclosures • All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. • The following planners/managers have the following to disclose: – John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest: Starfish Health (spouse) – Robert DuPont – Employment: Bensinger, DuPont & Associates-Prescription Drug Research Center
Learning Objectives 1. Explain the role of medications in assisting recovery from opioid addiction. 2. Define keys to success when combining MAT and behavioral therapy. 3. Examine the differences in heroin use among patients receiving buprenorphine for opioid use disorders. 4. Provide accurate and appropriate counsel as part of the treatment team.
The role of medications in assisting recovery from opioid addiction Adam Bisaga M.D. Professor of Psychiatry at CUMC Columbia University College of Physicians and Surgeons, New York, NY
Outline Medication-assisted treatment approach: historical context agonist-based treatment antagonist-based treatment Selecting the medication Recovery and MAT The role of PCSS in improving access to MAT
Medication-Assisted Treatment Approach: Historical Context
At beginning of 20th century, detoxification was considered adequate for treatment of narcotic addiction Addiction = physical dependence But detoxification methods often more dangerous than withdrawal itself E.g., beladona, cyanates, bromides, paraldehyde (promises of “magic” cures) Since detox removed physical dependence it was supposedly curative Patients who relapsed “chose” to do it - thus thought to possess an intractable character/moral defect (a deficit in self-control) Frequency of relapse led cities to set up narcotic clinics to legally provide heroin or morphine to addicts But short acting morphine required either multiple visits to clinic or take-home Deemed failures, patients were going from clinic to clinic and diversion occurred Opioid Addiction Cures: Early History (1900-20)
1914 Harrison Narcotic Act put severe restrictions on using opiates to maintain active addicts, permitted only detoxification Between 1919-1935, > 20,000 physicians were indicted and 10% went to prison; First “Drug War” By 1923, all clinics were closed Care for addicts was transferred from physicians to law enforcement Addiction medicine was decimated and disappeared for more than 50 years Psychiatrists were promoting a character pathology view of addiction to support institutionalization of addicts The addict was not a normal person after all but a “deviant” (pleasure-seeker, neurotic, psychopathic criminal, or inebriate who switched to heroin) New approaches: psychoanalysis, ECT, brain surgery, aversion therapy, LSD “Dark Age”: treatment was scarce and prison was frequent Cures: Dark Age (1920-1950)
Post WWII epidemic and the Second “Drug War” (1950’s) Heroin use emerge in the cities (NYC as a capital), crime on the rise New treatments focused solely on detoxification methods, propagated by the dominant treatment models (rehabs, NA, TC): abysmal failure Narcotic Farm approach: >90% relapsed The next wave of epidemic (60’s - baby boomers) was forming Heroin overdose as leading cause of death in young adults in NYC AMA/ABA recommended that clinics are set up to prescribe narcotics to addicts In NYC, Dr. Vincent Dole received funding to determine if a medical intervention can be developed to treat heroin addiction Cures: Drug-free treatment (1950-60)
In New York, Dole (with Nyswander and Kreek) began inpatient experiments with methadone and developed a metabolic theory of addiction in contrast to psychological theories Beginning shift from preoccupation with mechanics of withdrawal to managing craving and drug-seeking behaviors Reclaiming of the medical model of the disorder Methadone as a patient-centered medical treatment It become possible to promote medicine and care instead of law and control The new era: medical model of opioid dependence and its treatment (1964) Dole & Nyswander
Agonist-Based Treatment Approach
As originally proposed, methadone stimulates opioid receptors and “normalizes” functioning of this system (opioid deficit?) Not a heroin substitute Prevents withdrawal symptoms Relief of drug craving Stabilizes affect without producing euphoria or impairment in functioning Minimizes pathological brain responses to stress and drug cues Blocks effects of other opioids (tolerance blockade) By reducing drug-seeking, provides opportunity for the patient to begin changing their behavior and address other problems Treatment with methadone is a “corrective not a curative” intervention therefore may need to be used long-term/ indefinitely Treatment of Opioid Addiction with Methadone μ OR Full Agonist
Noticing a rapid beneficial effects in the first 6 patients D&N started methadone maintenance treatment (MMT) clinic in 1964 it had 300 patients 1 year later In 1966 the clinic model was adopted for expansion throughout the US 1972: 36,000 patients in NYC, 1976: 80,000 patients in the US Medical approach was highly controversial, states looked for excuses to shut clinics, doctors were threatened with arrests Concerns about diversion led to imposing strict governmental controls in 1973 and 1974 (NATA) that remain to this day Despite that, MMT expands in US and throughout most of the world Currently there are 330,000 patients in the US and > 1 million worldwide Methadone is on the WHO list of essential medications Underutilized in the US (90% of counties have shortage of services) It is “prohibited” in many parts of the world Methadone Maintenance Clinics
Meta-analytical studies show methadone’s superiority over treatment without agonists Significantly better at treatment retention and reduction of heroin use Higher doses are more effective than lower doses Smaller effect on reduction of crime, mortality, and HIV risk behavior Patients treated with methadone have a range of positive outcomes Marked reductions of heroin and other drug use Reduced morbidity & mortality Reduced crime Reduced risk of infections Improved social & work functioning However most data on effectiveness come from observational studies Methadone Maintenance: Outcomes (Mattick et al., 2009, et al., 2001; Faggiano et al., 2007)
Buprenorphine Developed in 1960’s, used as a long-acting analgesic partial agonist, ceiling on some effects (no possibility of overdose) lower risk of tolerance and physical dependence less withdrawal on discontinuation, low abuse potential Buprenorphine was proposed as an alternative to methadone first clinical trials in 80’s, offered to patients that were not interested/suitable for methadone Due to its pharmacological profile buprenorphine is safer in use than methadone less monitoring required less oversight of treatment contributes to lower effectiveness (non- adherence) and increased risks such as abuse and diversion Partial Agonistμ OR
Buprenorphine in France 1996: widespread introduction as a tablet in France with unrestricted prescribing by GP’s Dramatic drop in overdose deaths within few years Most buprenorphine is prescribed by GP’s, most have 5 patients but 50% of heroin users are treated (for free) because 20% of all physicians prescribe BUP However, diversion became a public health issue in francophone countries where it became a drug used intravenously (“poor‘s man heroin”) (Auriacombe et al., 2001, 2004) (Schwartz et al., 2013)
A combo product (buprenorphine/naloxone: 4/1 ratio) is introduced in the US in 2003 with restricted prescribing (training, limited # of patients) addition of naloxone decreases but not eliminates the risk of misuse Currently there are 0.5-1 million patients treated (exposed) mostly outside of the traditional addiction treatment programs Less than 4% of US physicians are licensed to prescribe it and only half of them are prescribing, 50% of prescribers treat 5 or fewer patients Buprenorphine in the USA SUBOXONE ZUBSOLV BUNAVAIL buprenorphine/ naloxone buprenorphine
One year long study Active group: 6 month of supervised buprenorphine, then take home dosing Control group: 6-day detox followed by INTENSIVE psychosocial treatment Very high drop-out rate and mortality in the detoxification-only group 20 15 10 5 0 0 50 100 200 250 350300150 Numberremainingintreatment Time from randomization (days) 20% dead 25% OPI + UTOX 75% dropped-out by 2 weeks Kakko et al., 2003 Buprenorphine maintenance is superior to intensive medication-free treatment
Prescription opioids abusers (n=653) Adaptive design, patients who relapsed were re-treated in phase II) Conclusions: - Tapering from opioid maintenance after a period of successful improvement leads to a nearly universal relapse - No benefit of added drug counselling Buprenorphine discontinuation leads to relapse Model for limiting treatment duration 1 month + taper 3 months maintenance Abstinent 3 months + taper 2 mos f/u Weiss et al., 2011
Among patients with an excellent 6 month response to treatment only 40% will remain in (free) treatment for 2 years Poor treatment retention is a major barrier to success for young adults Buprenorphine treatment in community settings Matson et al., 2014 Long‐Term Treatment with Buprenorphine/Naloxone in Primary Care: Results at 2–5 Years Fiellin et al., 2008
Retention in treatment: long-term outcomes for MMT vs. BMT Retention in treatment is superior in optimized (flex dose) MMT vs BMT Patients started with BMT had lower treatment participation and higher opioid use during the 5-yrs as compared to patients treated with MMT At f/u close to 50% of patients were using opioids (less in MMT than BMT) Days of opioid use per month Hser et al., 2015 Patient retention in treatment
Effectiveness of methadone (MMT) vs. buprenorphine (BMT) Retention in treatment (but not opioid use) is superior in optimized MMT vs BMT (e.g., flexible dose) MMT and BMT is similarly effective whether delivered in a primary care or outpatient clinic setting as compared to the specialized program Adjunct psychosocial and contingency interventions (e.g. financial incentives for opiate-free urines) enhance the effects of both MMT and BMT No significant differences in serious adverse effects for MMT compared with BMT some evidence suggests lower mortality with BMT vs. MMT Overall greater benefits for MMT may be balanced by better safety of BMT and preference of patients (Mattick et al., 2009, et al., 2001; Connock et al., 2007)
Treatment with agonists: summary Two major medications that dominate the field Specialized treatment centers using methadone (MMT) Outpatient-based treatment using buprenorphine (OBOT) Strong and extensive evidence of effectiveness, conferring several major benefits BUT: Risk of harm Concerns about diversion Fail to keep patients in treatment over the long haul May limit patient’s involvement in recovery community Other agonist options: Buprenorphine XR (implant and injection) SR morphine Supervised heroin maintenance
Antagonist-Based Treatment Approach
Opioid antagonist attach to the receptor and block other opioids from exerting any effects Naltrexone is a long-acting, high affinity, competitive opioid receptor antagonist with an active metabolite At sufficient blood levels naltrexone fully blocks all opioid effects Naltrexone tablet was approved in 1984 for the blockade of exogenously administered opioids Naltrexone injection (extended release, Vivitrol) was approved in 2010 for prevention of relapse following opioid detoxification Antagonist-based treatment
The concept of using opioid blockers after detoxification to treat opioid addiction developed in parallel to methadone First introduced in 1970s as oral preparations, with disappointing results Difficulty with treatment initiation, low patient acceptability/adherence Reviews concluded that there is no evidence that naltrexone is effective beyond selected patient groups which discouraged its clinical use 1980s brought new developments: Clonidine found effective in treating withdrawal Development of naltrexone-assisted detoxification methods, an opportunity to continue with naltrexone as a relapse prevention agent Buprenorphine was introduced for detoxification Work with naltrexone continued in 1990-2000s Behavioral therapy was developed to improve adherence to oral naltrexone Long-acting preparations of naltrexone become available to overcome problems with non-adherence to oral preparations Brief History of Naltrexone-based Treatment
Injections 1st gen: oil suspension 2nd gen: microspheres with NTX in suspension (Vivitrol) licensed in 2007 Improving Treatment Retention Using Long-Acting Preparations Implants 1st gen compressed NTX c.1996, now licensed in Russia 2nd gen: NTX mixed with polymer matrix c. 2001
Behavioral component: blockade of the positive (reinforcing) effects of heroin leads to gradual extinction of drug seeking Patients who use while on naltrexone experience no effect and stop using Pharmacological component: naltrexone decreases reactivity to drug-conditioned cues and decreases craving thereby minimizing pathological responses contributing to relapse Patients on naltrexone have no urges to use Naltrexone Treatment: mechanism
Requirement of detoxification and a wait-period of 7-10 days after the last dose of an opioid before treatment can be initiated A major barrier for many patients who find difficult to tolerate withdrawal Further complicated by the reduction of inpatient/residential treatment programs Difficulty with the induction due to the possibility of precipitated or protracted withdrawal Patients do not feel well at the beginning of the treatment Requirement of close monitoring Antagonist-based Treatment: limitations
Retention in treatment is used as a primary outcome of treatment with NTX patients retained on NTX are mostly (90%) abstinent from opioids treatment drop-out is usually associated with relapse Treatment retention rate in groups treated with XR preparations is twice that of the oral group, approximating 50-70% at 6 months Efficacy of Naltrexone: oral vs. XR injection
Efficacy of XR-Naltrexone vs. placebo Trials comparing injection of naltrexone vs. placebo showed that patients receiving active naltrexone have Better treatment retention Less opioid use Lower craving for opioids
Efficacy naltrexone: summary Extended-release preparation(s) of naltrexone are more effective than the oral preparation and should be the treatment of choice Injection NXT can be supplemented with oral preparation if needed (e.g. delay in receiving injection) to maintain blocking blood levels XR preparation of naltrexone is a relatively new medication with limited effectiveness research to date There is less data available from controlled trials of XR-naltrexone as compared to methadone or buprenorphine No direct evidence yet available comparing efficacy of XR-naltrexone vs. buprenorphine Indirect comparisons show comparable treatment retention with lower level of ongoing opioid use No studies to suggest which patients will have a better response to XR-naltrexone vs buprenorphine Patient’s preference and clinical indications should determine the choice of medication
Initiation of MAT: Patient and Medication Selection
A range of treatment goals Medically oriented treatment Protection against risk of OD and death Cessation of illicit opioid use (>90% negative toxicology) Improvement in physical and psychological health No dependence on other substances No misuse/diversion of medications Behaviorally oriented treatment Teach skills necessary to cope with cravings and life stressors without drugs The ultimate goal is to support long-term recovery to be maintained with or without medication sustained recovery with abstinence from all substances minimization of harms from ongoing use Opioid Dependence Treatment Goals
Barriers to implementing MAT Lack of familiarity with the medications, limited training in addictions Resistance from the treatment community to change the standard approach (detox followed by “drug-free” program and AA/NA In 12-step community, using medication to support abstinence is considered unnecessary (even antithetical) for recovery Major rehabilitation programs “do not support use of medications” targeting addictions Cultural sentiment that addicts are best served by joining AA/NA However, standard approach is not only ineffective but dangerous Detoxified patients have elevated risk of overdose and death Detoxification not followed by the medication to prevent relapse should be considered a malpractice (iatrogenic death) maintaining an ineffective practice against the scientific evidence would not be acceptable in any other branch of medicine
OTP Addiction Medicine/Psychiatry Practice Opioid User Inpatient Detoxification Unit Methadone Buprenorphine (OB) Naltrexone Residential Programs NaltrexoneBuprenorphine Psychosocial Only Current treatment system is fragmented into “one size fits all” silos Buprenorphine (DOT)
Comprehensive Outpatient Treatment Program (HUB) Medication and Psychosocial Treatments Opioid User Methadone Buprenorphine (DOT) Residential Programs NaltrexoneBuprenorphine (OB) Addiction or Primary Care Outpatient Practice A comprehensive treatment program that offers multiple options “under one roof” allowing a smooth transition from one option to another according to patient’s needs
Opioid Dependent Patients who are NOT Physically Dependent YES Relapse Prevention CBT Support Groups NALTREXONE XR NO Relapse Prevention CBT Support Groups NALTREXONE P.O. PRN Returning to High Risk Environment Increased stress Persistent Craving
Educate About Treatment Options Assess Patient’s Preference Assess Prognostic Factors Determine First-Line Treatment Abstinence Induction Using AGONIST Detoxification and Relapse Prevention Using ANTAGONIST NALTREXONE XR STABILIZATION Yes No METHADONE STABILIZATION BUPRENORPHINE STABILIZATION METHADONE MAINTENANCE NALTREXONE XR MAINTENANCE Yes Response Response BUPRENORPHINE MAINTENANCE No Yes Response Patients who are actively using No
Choosing methadone vs buprenorphine: factors to consider Interest in office vs. clinic-based treatment Ability to adhere to treatment/program rules Ability to follow safety procedures (e.g., monitor medication supply) Medical and psychiatric stability Use of other substances/severity of other SUDs Other medications that may interfere with one of the agonists What additional resources the patient need Additional support, stability of housing, employment History and response to previous treatments
AGONIST ANTAGONIST Maintain physiological dependence/withdrawal on stopping + - Reinforcing effects promoting medication adherence ++ - Euphoric effects/abuse/diversion ++ - Potential for tolerance development +/- - Incompatible with ongoing illicit opioid use - + Protection against overdose (in adherent patients) + + May alter use of other drugs +/- ++ Duration of treatment Indefinite? ? Cultural/ideological barriers to availability ++ - Professional/public opposition ++ + Choosing AGONIST vs. ANTAGONIST
Selection of candidates for naltrexone Patients who are not interested or able to be on agonist maintenance Patients who are detoxified and abstinent but at risk for relapse Patients who failed prior treatment with agonist Patients with less severe form of a disorder Young adults often unwilling to commit to a long-term agonist maintenance Individuals who use opioids sporadically Patients successful on agonist but who want to discontinue them without risking relapse
Patients who may be better candidates for agonists Patients with history of overdoses, particularly following detoxification Patients with serious psychiatric or medical problems Patients with limited social supports (unstable lives, homeless) Patients who have been opiate-free but never felt “normal” Patients with chronic pain requiring intermittent opioid treatment Patients with severe GI disorders exacerbating during withdrawal/abstinence Patients with advanced liver disease
Recovery and MAT
Early on methadone was thought to be a tool to assist in recovery Emphasis of therapeutic alliance Recovering staff were role models High-dose and no limits on treatment duration As the treatment expanded and regulations were imposed the dominant approach shifted from recovery towards a “harm reduction” Focus on reduction in social costs (crime, infections) Decrease in ancillary services (for-profit programs) Reduction of methadone dose and the duration of treatment This turn away from the focus on recovery brought on another wave of criticism and public/professional stigma Can MAT be compatible with Recovery (White and Mojer-Torres, 2010)
Reaffirmation of MMT effectiveness by professional, scientific, and governmental organizations Advocacy efforts of MMT patients Accreditation of programs, focus on improving quality Understanding opioid addiction as a chronic disorder Emergence of recovery as an organizing paradigm Efforts to extend acute care model to models of recovery management (RM) & recovery-oriented systems of care (ROSC) Revitalization of MMT (1990-present) (White and Mojer-Torres, 2010)
Betty Ford Institute definition of recovery “Recovery from substance dependence is a voluntarily maintained lifestyle characterized by sobriety, personal health, and citizenship” Was expanded to include patients treated with medications “…formerly opioid-dependent individuals who take naltrexone, buprenorphine, or methadone as prescribed and are abstinent from alcohol and all other nonprescribed drugs would meet this definition of sobriety” Recovery and medication status: BFI Consensus Statement (Betty Ford Institute 2007)
Low attractiveness to patients Limited access/waiting lists Sub-therapeutic dosing and dose manipulation Premature administrative discharges, forced tapers High dropout rates, low rates of sustained engagement High-rates of post-discharge relapse and mortality Low engagement in recovery community Promoting role models/peer support Combatting professional/social stigma attached to MAT Engaging families in a sustained recovery-support process Recovery Management approach aims to address some of MAT limitations (White and Mojer-Torres, 2010)
Utilize Strength-Based Management: building meaningful and satisfying lives Transition patients from professionally to a patient-directed recovery plan Expands the care team to include a variety of professionals Shift the treatment model from a directive expert model to a recovery partnership model (consideration for patient’s autonomy) Assure optimum duration of MAT (focus is on recovery not duration of medication tx) Expand the services within the vibrant culture of recovery (“Recovery is Contagious”) Extend delivery of recovery support services into the community (co-location) Proactively link patients/families to recovery community support resources Provide post-treatment monitoring, support and, early re-intervention if needed Recovery checkups & re-engagement Evaluate outcomes using (long-term) measures of recovery Global health, quality of life, community contribution Conduct anti-stigma campaigns RM approach seeks to: (White and Mojer-Torres, 2010)
The role of PCSS in improving access to MAT
The Providers’ Clinical Support System for Medication Assisted Treatment is an initiative funded by SAMSHA in response to the opioid overdose epidemic PCSS-MAT is a national training and mentoring program developed to educate healthcare professionals on the use and availability of the latest pharmacotherapies What is PCSS-MAT?
The overarching goal of PCSS-MAT is to make available educational and training resources on the most effective medication-assisted treatments Buprenorphine Naltrexone Methadone PCSS-MAT aims to reach providers who serve patients in a variety of settings, including primary care, psychiatric care, and pain management programs PCSS-MAT Goal and Target Audience
PCSS-MAT Training Modalities PCSS-MAT offers no-cost training activities with CME to health professionals through the use of: Buprenorphine Waiver Trainings Naltrexone Trainings Webinars (Live and Archived) Online Modules Case Vignettes One-on-one and Small Group Discussions—clinical coaching In addition, PCSS-MAT offers a comprehensive library of resources Clinical Guidances and other educational tools Community Resources Listserv - Provides a “Mentor on Call” to answer questions about content presented through PCSS-MAT To join email: pcssmat@aaap.org
PCSS-MAT Mentoring Program Designed to offer general information to clinicians about evidence- based clinical practices in prescribing medications for opioid addiction A national network of trained providers with expertise in medication- assisted treatment, addictions and clinical education Three-tiered mentoring approach allows every mentor/mentee relationship to be unique and designed to the specific needs of both parties The mentoring program is available at no cost to providers
• 123 webinars and online modules with 22,399 training participants • 212 Buprenorphine waiver trainings with 3,325 training participants • 55 mentors and 200 mentees and growing • 112 clinicians have participated in Small Group Discussions within mentoring program (new initiative starting 2015) PCSS-MAT Program Highlights
Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for Medication Assisted Treatment (grant no. 5U79TI024697) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government. PCSS-MAT is a collaborative effort led by American Academy of Addiction Psychiatry in partnership with: American Osteopathic Academy of Addiction Medicine, American Psychiatric Association, American Society of Addiction Medicine and Association for Medical Education and Research in Substance Abuse. For more information visit: www.pcssmat.org For questions email: pcssmat@aaap.org Twitter: @PCSSProjects
Combination of Medication Assisted Therapy and Behavioral Therapy: Key to Success
Disclosure Statement • Phil Walls, RPh – Employment and ownership interest: Matrix HCS, Inc. • Michael Coupland, CPsych, RPsych CRC, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
Learning Objectives • Explain the role of medications in assisting recovery from opioid addiction. • Define keys to success when combining MAT and behavioral therapy. • Examine the differences in heroin use among patients receiving buprenorphine for opioid use disorders. • Provide accurate and appropriate counsel as part of the treatment team.
Opioid Receptors • Three types of opioid receptors: – Mu receptors are responsible for interpretation of pain, analgesia, respiratory depression, physical dependence, and euphoria – Kappa receptors are responsible for modest analgesia, with little respiratory depression and little physical dependence – Delta receptors are not fully understood, however agonists show poor analgesia • Pharmacologic properties of opioids based on agonist or antagonist effects at the Mu and Kappa receptor sites.
Agonist vs. Antagonist • Pure agonist has affinity for binding at receptor sites and activates receptors to produce effects • Pure antagonist has affinity for binding and occupying receptors but does not produce effect and therefore blocks agonists from binding • Mixed agonist-antagonist has affinity for binding at receptors but produces an agonist effect at one receptor and an antagonist effect at the other receptor
Agonists and Antagonists
Opioid Classification Drugs Mu Receptor Kappa Receptor Pure Agonists Agonist Agonist Mixed Agonist- Antagonist Antagonist Agonist Pure Antagonist Antagonist Antagonist
Agonist vs Antagonist
Drug Classification Agonists Mixed Agonist- Antagonist Antagonists Morphine Pentazocine Naloxone Heroin Nalbuphine Naltrexone Hydromorphone Butorphanol Nalmephine Fentanyl Buprenorphine Codeine Oxycodone Methadone
Efficacy of Analgesic Effect
Response to the Heroin Epidemic The Centers for Disease Control and Prevention recommend: • Prevent people from starting heroin • Reverse heroin overdose • Reduce heroin addiction With regard to the latter, the CDC recommends that individuals addicted to heroin or prescription opioids have access to medication assisted treatment, which combines therapy with drugs like methadone, buprenorphine or naltrexone with counseling and behavioral therapy.
Consider the Danger of Misuse One tragic report comes from Kentucky where the state has been struggling to deal with first a prescription opioid epidemic and now a heroin epidemic like so many other states. Passage of House Bill 1 in 2012 by the Kentucky legislature wa designed to control pill mills and overprescribing of opioids, and achieved one goal: prescriptions for these drugs declined. However, the legislation did not put similar restrictions on prescriptions for buprenorphine. When used properly these drugs can help an addict quit using heroin without going through horrible withdrawal - however, one addict was quoted as saying: “it was just a great substitute for heroin. It was like doing the same thing, really.” The initial impact of HB 1 was to cause the state’s pill mills to turn into facilities that provided buprenorphine to addicts without any of the oversight necessary to truly help the patient.
HB 1 Initially Led to a Surge in the Abuse of Buprenorphine
High Cost of a Proposed Cure
In the workers’ compensation area, most patient on long term opioids: Do not have pre-existing traits or behaviors indicative of addiction Take their opioids as prescribed and do not have aberrant drug screens, drug seeking behavior Have physicians who are unwilling to make changes to the prescribing patterns Prescribing physicians are willing to use psychologist support to assist patients to gain non pharmaceutical pain management skills and to increase function
$ Chronic Pain & Disability Behavior $ Biopsychosocial Model of Chronic Pain Lifestyle: Exercise, Smoking, Alcohol and Drugs, Obesity / Diet Work Attachment / Age Depression / Anxiety Personality Disorders Hx of Childhood Abuse Perceived Injustice (retribution owed) Fear Avoidant Behavior (Guarding) Catastrophic Thinking Cortisol, substance p, serotonin, Norepinephrine, vasodilatation, vasoconstriction
Dependence & ‘Addiction’ Neurobehavioral Effects of Opioids Increase Noradrenaline to combat the depressive effects Turn off innate pleasure responses Release Dopamine (Pleasure) ***Tolerance Develops Demotivation, compromised ability to regulate unsafe behaviors Paired association of Pleasure with initiating reason for opioids Depress Breathing, Blood Pressure, Alertness
Early Intervention Screening …..to assess risk for chronic pain, delayed recovery and opioid abuse
Early Identification of BioPsychoSocial Risk Factors 1. Psychosocial risk factors have been validated a. Meta Analyses b. Prospective studies c. Control group studies 2. A Pain Screening Questionnaire has been validated • Scores predict time loss / medical spend /function 3. Brief Cognitive Behavioral Therapy (CBT) interventions can successfully intervene • less time loss / medical spend /greater function
Webster LR, Webster RM. Pain Med. 2005;6(6):432-442. Misuse 40% Abuse: 20% Total Pain PopulationAddiction: 2% to 5% Prevalence of Misuse, Abuse and Addiction
COPE with Pain Cognitive Behavioral Therapy (CBT)  CBT is brief and time-limited.  A sound therapeutic relationship is necessary for effective therapy, but not the focus.  CBT is a collaborative effort between therapist and client.  CBT is based on stoic philosophy.  CBT is structured and directive.  CBT is based on an educational model.  Homework is a central feature of CBT.
How to Treat Psychosocial Factors without ‘Buying’ an unwarranted Psych Claim The new ‘health and behavior assessment and intervention’ codes ensure the claimant does not become further ‘medicalized’ Psychiatric diagnosis and treatment codes are NOT used unless there is already a mental health accepted diagnosis CPT Code Descriptor 96150 Initial assessment to determine biological, psychological and social factors affecting health and any treatment problems 96151 Reassessment to evaluate condition and determine need for further treatment
Treatment RTW Outcomes Control Group Intervention Group High Risk and Very High Risk High Risk Very High Risk Sample Size 36 62 109 % claims closed at 26 weeks 33% 76% 62% % working at 26 weeks 17% 68% 39% Avg claim duration at 26 weeks 24 weeks 18.7 weeks 20.2 weeks Coupland, M., Margison, D. Early Intervention in Psychosocial Risk Factors for Chronic Pain, Musculoskeletal Disorders and Chronic Pain Conference, Feb 2011, Los Angeles, CA
Treatment High Risk vs. Low Risk Psychosocial • 9% Fewer Pt. get Physical Therapy • 10% Fewer Pt. get Imaging Studies • 13% Fewer Pt. get Injections • 6% Fewer Pt. get Surgeries • 5% More Pt. get Vocational Rehabilitation Outcomes @26 wks+ Coupland, M., Margison, D. Early Intervention in Psychosocial Risk Factors for Chronic Pain, Musculoskeletal Disorders and Chronic Pain Conference, Feb 2011, Los Angeles, CA
Thank you!
Are Patients Receiving Buprenorphine for Opioid Use Disorders Different in Important Ways if they Used Heroin? Robert L. DuPont, M.D., President Institute for Behavior and Health, Inc. www.ibhinc.org Katherine Garcia-Rosales, B.S., Faculty Research Assistant Center for Substance Abuse and Research www.cesar.umd.edu
Disclosure • Robert L. DuPont, M.D. wishes to disclose that he was Vice President of Bensinger, DuPont & Associates (1982-2015) and Chairman of its subsidiary Prescription Drug Research Center (2003-2015). Content will be presented in a fair and balanced manner. • Katherine Garcia-Rosales, B.S. has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
Workshop Learning Objectives 1. Explain the role of medications in assisting recovery from opioid addiction 2. Define keys to success when combining MAT and behavioral therapy 3. Examine the differences associated with heroin use by patients receiving buprenorphine for opioid use disorders 4. Provide accurate and appropriate counsel as part of the treatment team.
The Clinical Challenge • To distinguish between patients who use opioids as prescribed and those who use them nonmedically, often with other drugs, and/or divert them to other drug users • This is difficult because addicted patients and those diverting drugs lie; physicians are not good at recognizing dishonest patients
A Crucial Distinction: Addiction vs. Physical Dependence • Addiction has two key features: – Continued use despite problems – Dishonesty • Addiction seldom involves only one drug whereas physical dependence without addiction almost always does involve only one drug • The treatment of addiction is medically challenging and lifelong
Physical Dependence • The body’s adaptation to chronic use of a specific drug or related class of drugs, e.g., opioid dependence • Withdrawal, when the drug is abruptly stopped, is commonly associated with a reversal of the effects of the drug and is often intensely unpleasant • Treatment for physical dependence is gradual dose reduction and usually relatively brief
Today’s Presentation • Explores the context of the heroin epidemic • Focuses on one important new finding among patients being treated for opioid dependence • Those who have used heroin are different from those who have not used this drug • This difference matters for both prevention and treatment
• Round one with heroin was from 1898 to 1914 – Heroin over-the-counter – Rural, middle aged and mostly female • Round two was from 1970 to 1978 – Both heroin use and sale linked to urban crime – Mostly minority young men • Round three is ongoing today – In the context of massive use of prescription opioids – Profound improvement in heroin distribution – easier to get, more potent and far cheaper Recurring Heroin Epidemics in the US DuPont, 1971; DuPont & Greene, 1973; CDC 2015
Long-Term Changes in Heroin Use • Demographics of heroin addiction/treatment have changed over the last 50 years – From an inner-city, minority criminal problem – To a wider geographical distribution, involving primarily white men and women in their 20s and 30s living in suburban and rural areas • Heroin use in the general population is rare compared to many other drugs • The number of new heroin users is increasing and overdose deaths are rising dramatically Cicero, et al., 2014; Center for Behavioral Health Statistics and Quality (CBHSQ) 2015
Rx Opioid-Heroin Use Connection • During the 1960s heroin epidemic users often chose heroin as their first drug • Now most heroin users previously used prescription opioids nonmedically before starting heroin use • Before today’s heroin users first used prescription opioids, most used other drugs of abuse, often starting in adolescence Jones, 2013; Cicero, 2014
Today’s “Round Three” – Initiation to Opioid Use • In 2014, there were 1.4 million initiates to nonmedical use of prescription pain relievers – Lower than in recent years – Average age of first use 21.2 years • 212,000 initiates to heroin – Significantly higher than in 2006 (90,000 initiates) – Average age of first use 28 years SAMHSA, 2014; CBHSQ, 2015
National Changes in Drug Overdose Deaths per 100,000 2003-2014 Park & Bloch, 2016
Age-Adjusted Rates of Death Related to Rx Opioids and Heroin Drug Poisoning in the US, 2000-2015 Data from CDC reported in Compton, Jones, & Baldwin, 2016
Nonmedical Use of Prescription Opioids and Heroin During the Previous Year Among Persons 12 Years of Age or Older, 2002-2014 Data from CBHSQ reported in Compton, Jones, & Baldwin, 2016
Why the Dramatic Rise in Heroin Use and Overdose Deaths NOW? • Rise in prescription opioid use • Dramatic improvements in the heroin supply Compton, Jones, & Baldwin, 2016
It’s the Supply, Stupid! • Heroin is delivered anonymously to your door ordered by phone or online • Low cost and high potency of heroin • Implications for drug policy and the role of the criminal justice system
New Research Questions • How can physicians identify prescription opioid patients at risk for transitioning to heroin? • How are patients with opioid use disorders who use heroin different from those who do not?
Persons Receiving Buprenorphine for Outpatient Treatment of Opioid Disorders: Are They Different If They Also Used Heroin? Garcia-Rosales, K., and Wish, E. D. Persons Receiving Buprenorphine for Outpatient Treatment of Opioid Disorder: Are They Different if They Also Used Heroin? 21st Annual University at Buffalo Undergraduate Research Conference and 11th Annual Graduate School Opportunities Program, July 23-25, 2015; Bioscience Day at University of Maryland, November 19, 2015
Methodology Research Design: • Secondary analysis of existing data from 157 patients who enrolled in an outpatient treatment program in the Maryland- Washington D.C. area who were being prescribed buprenorphine • Quasi-experimental design comparing patients classified by self-reported heroin and prescription opioid use
Instrument Instrument: Self-administered semi-structured questionnaire developed by IBH: • Demographics • Self-reported lifetime use of: illegal drugs (marijuana, PCP, heroin) and Rx opioids (buprenorphine, methadone, OxyContin/other Rx opioids)
• Majority of the sample were males and almost half were below age 30 • Half or more used OxyContin/other Rx opioids or buprenorphine without a prescription • About 1/4 (26%) had used methadone without a prescription
• Only 6% (9 persons) reported using heroin only • The analyses that follow compare: - 80 persons (51%) who had used Rx opioids with or without a prescription and heroin with - 68 persons (43%) who had used Rx opioids with or without a prescription only
• Users of Rx opioids + heroin: - were younger than those who had not used heroin - began using Rx opioids before heroin - initiated Rx opioid use earlier than the non-heroin users • 2/3 (66%) of the Rx opioids + heroin users had used Rx opioids for the first time before age 20
• Users of Rx opioids + heroin were much more likely to have used multiple drugs; 79% vs. 30% used three or more drugs • Only 6% of the Rx opioids + heroin users used only one additional drug
Limitations • Sample likely not representative of the whole population in treatment with buprenorphine • Sole reliance on self-reported drug use • Limited information collected about study participants
Summary of Findings • In this population of patients, there were two distinct groups of patients who were identified based on past history of heroin use • Persons receiving buprenorphine for treatment of opioid disorder who used Rx opioids + heroin were more likely to misuse other drugs, to have begun use earlier, and to engage in polydrug use • Only a small minority (6%) who used Rx opioids + heroin were not polydrug users and might be the new kind of heroin users thought to be produced by the current epidemic of prescription opioid misuse
Study Implications • Physicians and health workers should capture an extensive drug use history from patients being treated for opioid use disorders • Urine drug tests could be used to enhance self- reported drug use history information • Patients who have used heroin are likely to need special interventions targeted at their polydrug use • Effective treatment needs to fully address the patient’s entire drug problem
Few Nonmedical Rx Opioids Users Transition to Heroin • Nationally, only a small subset of people who started using prescription pain relievers non- medically transitioned to heroin within 5 years Initiated Non-Medical Use of Pain Relievers (10 million over 5 years) Initiated Heroin Use (500,000 over 5 years) 20% of Recent Heroin Initiates Did Not Previously Use Prescription Pain Relievers Only 3.6% of Initiates to Non-Medical Use of Pain Relievers (360,000) Transitioned to Heroin 80% of Recent Heroin Initiates Previously Used Prescription Pain Relievers Muhuri, Gfroerer, & Davies, 2013
Individuals Who Use the Less Prevalent Drugs are Most Likely to Use Many Drugs Provided by the Center for Substance Abuse Research
Implications for Prevention and Treatment • Not every dependent prescription opioid user is at risk to switch to heroin • To prevent a switch to heroin, pain management physicians need to focus on patients who are long-time heavy users of alcohol and other drugs of abuse
Additional Thoughts on Opioid Addiction Treatment • Medications only work while they are taken • Opioid dependence is a life-long disease • Most forms of treatment, including opioid substitution therapy (OST), is short-term • OST has no effect on the use alcohol or other drugs • What happens to opioid addicts when they leave OST?
Thank you! Questions and Comments
Institute for Behavior and Health, Inc. • IBH is a 501(c)3 non-profit organization that develops strategies to reduce drug use • For more information and resources, visit the IBH websites: www.IBHinc.org www.StopDruggedDriving.org www.PreventTeenDrugUse.org www.PreventionNotPunishment.org
Center for Substance Abuse Research • The Center for Substance Abuse Research (CESAR), at the University of Maryland at College Park, is dedicated to addressing the problems substance abuse creates for individuals, families, and communities • For more information and resources, visit the CESAR websites: www.cesar.umd.edu www.ndews.umd.edu
References • Centers for Disease Control and Prevention. (2015, July 7). Today’s heroin epidemic. Atlanta, GA: CDC. Available: http://www.cdc.gov/vitalsigns/heroin/index.html • Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H- 50). Available: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf • Cicero, T. J., Ellis, M. S., Surratt, H. L., & Kurtz, S. P. (2014). The changing face of heroin use in the United States. JAMA Psychiatry, 71(7), 821-826. • Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid use and heroin use. New England Journal of Medicine, 374, 154-163. • DuPont, R. L. (1971). Profile of a heroin-addiction epidemic. New England Journal of Medicine, 285, 320-324. • DuPont, R. L. & Greene, M. H. (1973). The dynamics of a heroin addiction epidemic. Science, 181, 716-722. • Jones, C. M. (2013). Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers—United States, 2002-2004 and 2008-2010. Drug and Alcohol Dependence, 132, 95-100. • Muhuri, P. K., Gfroerer, J. C., & Davies, M. C. (2013). Associations of non-medical pain reliever use and initiation of heroin use in the United States. CBHSQ Data Review. Rockville, MD: Substance Abuse and Mental Health Services Administration. • National Institute on Drug Abuse. (2015, December). Overdose death rates. Rockville, MD: Author. Available: http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates • Park, H. & Bloch, M. (2016, January 19). How the epidemic of drug overdose deaths ripples across America. New York Times. Available: http://www.nytimes.com/interactive/2016/01/07/us/drug-overdose-deaths-in-the-us.html • Substance Abuse and Mental Health Services Administration. (2014).Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration. Available: http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.htm
Additional Reading • Centers for Disease Control and Prevention. (2014, October 2). Heroin overdose deaths increased in many states through 2012; still twice as many people died from prescription opioid overdoses. CDC Newsroom. Atlanta, GA: CDC. Available: http://www.cdc.gov/media/releases/2014/p1002-heroin-overdose.html • Centers for Disease Control and Prevention. (2015, July 7). Today’s heroin epidemic. CDC Vital Signs. Atlanta, GA: CDC. Available: http://www.cdc.gov/vitalsigns/heroin/ • Centers for Disease Control and Prevention, Division of News & Electronic Media, Office of Communications. (2013, February 20). Opioids drive continued increase in drug overdose deaths. Press Release. Atlanta, GA: CDC. Available: http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html • Centers for Disease Control and Prevention, National Center for Health Statistics. (2015, June 12). NCHS data on drug poisoning facts. NCHS Fact Sheet. Atlanta, GA: CDC. Available: http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.htm • Chou, R., Turner, J. A., Devine, E. B., et al. (2015). The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways workshop.Annals of Internal Medicine. doi:10.7326/M14-2559 Available: http://annals.org/article.aspx?articleid=2089370 • Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid use and heroin use. New England Journal of Medicine, 374, 154-163. • Frenk, S., Porter, K., Paulozzi, L. (2015) Prescription Opioid Analgesic Use Among Adults: United States 1999- 2012. NCHS Data Brief, No. 189. Available: http://www.cdc.gov/nchs/data/dataBriefs/db189.pdf • Hedegaard, H., Chen, L., Warner, M. (2015) Drug-poisoning Deaths Involving Heroin: United States, 2000- 2013. NCHS Data Brief, No. 190. Available: http://www.cdc.gov/nchs/data/databriefs/db190.pdf
• Jones, C. M. (2012a). Prescription Drug Abuse and Overdose in the United States, presented at Third Party Payer and PDMP Meeting, December 2012. Available: http://www.pdmpexcellence.org/sites/all/pdfs/Jones.pdf • Jones C. M. (2012b). Frequency of prescription pain reliever nonmedical use, 2002-2003 and 2009-2010. Archives of Internal Medicine, 172(16), 1265-1267. • National Institute on Drug Abuse. (2014, October). Heroin. DrugFacts. Rockville, MD: Author. Available: http://www.drugabuse.gov/publications/drugfacts/heroin • New York Times Editorial Board. (2015, March 2). Painkiller abuses and ignorance. New York Times, p. A18. • Rudd, R. A., Paulozzi, L. J., Bauer, M. J., et al. (2014, October 3). Increase in heroin overdose deaths – 28 states, 2010 to 2012. Morbidity and Mortality Weekly Report, 63(39), 849-854. • SAMHSA National survey of substance abuse treatment services. 2006. Found at: http://wwwdasis.samhsa.gov/webt/state_data/US06.pdf. • Sheir, R. (2014, November 21). Meet the man who tackled D.C.’s first heroin epidemic. WAMU 88.5 Metro Connection. Available: http://wamu.org/programs/metro_connection/14/11/21/meet_the_man_who_tackled_dcs_first_heroin_e pidemic • Volkow, N. (2014, May 14). America’s Addiction to Opioids: Heroin and Prescription Drug Abuse. Presented to the Senate Caucus on International Narcotics Control. Available: http://www.drugabuse.gov/about- nida/legislative-activities/testimony-to-congress/2014/americas-addiction-to-opioids-heroin-prescription- drug-abuse • Wood, G. (2014, March 19). Drug dealers aren’t to blame for the heroin boom. Doctors are. New Republic. Available: http://www.newrepublic.com/article/116922/what-makes-heroin-crisis-different-doctor- prescribed-pills
Medication-Assisted Treatment Presenters: • Adam Bisaga, MD, Professor of Psychiatry, Columbia University Medical Center • Phillip Walls, RPh, Chief Clinical Officer, myMatrixx • Michael Coupland, MA, RPsych, Network Medical Director, IMCS Group • Robert L. DuPont, MD, Founding President, Institute for Behavior and Health, Inc. • Katherine Garcia-Rosales, BS, Research Assistant, Center for Substance Abuse Research, University of Maryland College Park Pre-Summit Workshop Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA, President- elect, American Society of Addiction Medicine, and Member, Rx and Heroin Summit National Advisory Board

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Rx16 presummit mat-mon_200_1_bisaga_2walls_3coupland_4dupont_5garcia-rosales

  • 1.
    Medication-Assisted Treatment Presenters: • AdamBisaga, MD, Professor of Psychiatry, Columbia University Medical Center • Phillip Walls, RPh, Chief Clinical Officer, myMatrixx • Michael Coupland, MA, RPsych, Network Medical Director, IMCS Group • Robert L. DuPont, MD, Founding President, Institute for Behavior and Health, Inc. • Katherine Garcia-Rosales, BS, Research Assistant, Center for Substance Abuse Research, University of Maryland College Park Pre-Summit Workshop Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA, President- elect, American Society of Addiction Medicine, and Member, Rx and Heroin Summit National Advisory Board
  • 2.
    Disclosures • Michael Coupland,MA, RPsych; Katherine Garcia-Rosales, BS; and Kelly J. Clark, MD, MBA, FASAM, DFAPA, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services. • Adam Bisaga, MD – Contracted Research: Alkermes • Robert DuPont – Employment: Bensinger, DuPont & Associates-Prescription Drug Research Center • Phillip Walls, RPh – Employment and ownership interest: Matrix HCS, Inc.
  • 3.
    Disclosures • All planners/managershereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. • The following planners/managers have the following to disclose: – John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest: Starfish Health (spouse) – Robert DuPont – Employment: Bensinger, DuPont & Associates-Prescription Drug Research Center
  • 4.
    Learning Objectives 1. Explainthe role of medications in assisting recovery from opioid addiction. 2. Define keys to success when combining MAT and behavioral therapy. 3. Examine the differences in heroin use among patients receiving buprenorphine for opioid use disorders. 4. Provide accurate and appropriate counsel as part of the treatment team.
  • 5.
    The role ofmedications in assisting recovery from opioid addiction Adam Bisaga M.D. Professor of Psychiatry at CUMC Columbia University College of Physicians and Surgeons, New York, NY
  • 6.
    Outline Medication-assisted treatment approach:historical context agonist-based treatment antagonist-based treatment Selecting the medication Recovery and MAT The role of PCSS in improving access to MAT
  • 7.
  • 8.
    At beginning of20th century, detoxification was considered adequate for treatment of narcotic addiction Addiction = physical dependence But detoxification methods often more dangerous than withdrawal itself E.g., beladona, cyanates, bromides, paraldehyde (promises of “magic” cures) Since detox removed physical dependence it was supposedly curative Patients who relapsed “chose” to do it - thus thought to possess an intractable character/moral defect (a deficit in self-control) Frequency of relapse led cities to set up narcotic clinics to legally provide heroin or morphine to addicts But short acting morphine required either multiple visits to clinic or take-home Deemed failures, patients were going from clinic to clinic and diversion occurred Opioid Addiction Cures: Early History (1900-20)
  • 9.
    1914 Harrison NarcoticAct put severe restrictions on using opiates to maintain active addicts, permitted only detoxification Between 1919-1935, > 20,000 physicians were indicted and 10% went to prison; First “Drug War” By 1923, all clinics were closed Care for addicts was transferred from physicians to law enforcement Addiction medicine was decimated and disappeared for more than 50 years Psychiatrists were promoting a character pathology view of addiction to support institutionalization of addicts The addict was not a normal person after all but a “deviant” (pleasure-seeker, neurotic, psychopathic criminal, or inebriate who switched to heroin) New approaches: psychoanalysis, ECT, brain surgery, aversion therapy, LSD “Dark Age”: treatment was scarce and prison was frequent Cures: Dark Age (1920-1950)
  • 10.
    Post WWII epidemicand the Second “Drug War” (1950’s) Heroin use emerge in the cities (NYC as a capital), crime on the rise New treatments focused solely on detoxification methods, propagated by the dominant treatment models (rehabs, NA, TC): abysmal failure Narcotic Farm approach: >90% relapsed The next wave of epidemic (60’s - baby boomers) was forming Heroin overdose as leading cause of death in young adults in NYC AMA/ABA recommended that clinics are set up to prescribe narcotics to addicts In NYC, Dr. Vincent Dole received funding to determine if a medical intervention can be developed to treat heroin addiction Cures: Drug-free treatment (1950-60)
  • 11.
    In New York,Dole (with Nyswander and Kreek) began inpatient experiments with methadone and developed a metabolic theory of addiction in contrast to psychological theories Beginning shift from preoccupation with mechanics of withdrawal to managing craving and drug-seeking behaviors Reclaiming of the medical model of the disorder Methadone as a patient-centered medical treatment It become possible to promote medicine and care instead of law and control The new era: medical model of opioid dependence and its treatment (1964) Dole & Nyswander
  • 12.
  • 13.
    As originally proposed,methadone stimulates opioid receptors and “normalizes” functioning of this system (opioid deficit?) Not a heroin substitute Prevents withdrawal symptoms Relief of drug craving Stabilizes affect without producing euphoria or impairment in functioning Minimizes pathological brain responses to stress and drug cues Blocks effects of other opioids (tolerance blockade) By reducing drug-seeking, provides opportunity for the patient to begin changing their behavior and address other problems Treatment with methadone is a “corrective not a curative” intervention therefore may need to be used long-term/ indefinitely Treatment of Opioid Addiction with Methadone μ OR Full Agonist
  • 14.
    Noticing a rapidbeneficial effects in the first 6 patients D&N started methadone maintenance treatment (MMT) clinic in 1964 it had 300 patients 1 year later In 1966 the clinic model was adopted for expansion throughout the US 1972: 36,000 patients in NYC, 1976: 80,000 patients in the US Medical approach was highly controversial, states looked for excuses to shut clinics, doctors were threatened with arrests Concerns about diversion led to imposing strict governmental controls in 1973 and 1974 (NATA) that remain to this day Despite that, MMT expands in US and throughout most of the world Currently there are 330,000 patients in the US and > 1 million worldwide Methadone is on the WHO list of essential medications Underutilized in the US (90% of counties have shortage of services) It is “prohibited” in many parts of the world Methadone Maintenance Clinics
  • 15.
    Meta-analytical studies showmethadone’s superiority over treatment without agonists Significantly better at treatment retention and reduction of heroin use Higher doses are more effective than lower doses Smaller effect on reduction of crime, mortality, and HIV risk behavior Patients treated with methadone have a range of positive outcomes Marked reductions of heroin and other drug use Reduced morbidity & mortality Reduced crime Reduced risk of infections Improved social & work functioning However most data on effectiveness come from observational studies Methadone Maintenance: Outcomes (Mattick et al., 2009, et al., 2001; Faggiano et al., 2007)
  • 16.
    Buprenorphine Developed in 1960’s,used as a long-acting analgesic partial agonist, ceiling on some effects (no possibility of overdose) lower risk of tolerance and physical dependence less withdrawal on discontinuation, low abuse potential Buprenorphine was proposed as an alternative to methadone first clinical trials in 80’s, offered to patients that were not interested/suitable for methadone Due to its pharmacological profile buprenorphine is safer in use than methadone less monitoring required less oversight of treatment contributes to lower effectiveness (non- adherence) and increased risks such as abuse and diversion Partial Agonistμ OR
  • 17.
    Buprenorphine in France 1996:widespread introduction as a tablet in France with unrestricted prescribing by GP’s Dramatic drop in overdose deaths within few years Most buprenorphine is prescribed by GP’s, most have 5 patients but 50% of heroin users are treated (for free) because 20% of all physicians prescribe BUP However, diversion became a public health issue in francophone countries where it became a drug used intravenously (“poor‘s man heroin”) (Auriacombe et al., 2001, 2004) (Schwartz et al., 2013)
  • 18.
    A combo product(buprenorphine/naloxone: 4/1 ratio) is introduced in the US in 2003 with restricted prescribing (training, limited # of patients) addition of naloxone decreases but not eliminates the risk of misuse Currently there are 0.5-1 million patients treated (exposed) mostly outside of the traditional addiction treatment programs Less than 4% of US physicians are licensed to prescribe it and only half of them are prescribing, 50% of prescribers treat 5 or fewer patients Buprenorphine in the USA SUBOXONE ZUBSOLV BUNAVAIL buprenorphine/ naloxone buprenorphine
  • 19.
    One year longstudy Active group: 6 month of supervised buprenorphine, then take home dosing Control group: 6-day detox followed by INTENSIVE psychosocial treatment Very high drop-out rate and mortality in the detoxification-only group 20 15 10 5 0 0 50 100 200 250 350300150 Numberremainingintreatment Time from randomization (days) 20% dead 25% OPI + UTOX 75% dropped-out by 2 weeks Kakko et al., 2003 Buprenorphine maintenance is superior to intensive medication-free treatment
  • 20.
    Prescription opioids abusers(n=653) Adaptive design, patients who relapsed were re-treated in phase II) Conclusions: - Tapering from opioid maintenance after a period of successful improvement leads to a nearly universal relapse - No benefit of added drug counselling Buprenorphine discontinuation leads to relapse Model for limiting treatment duration 1 month + taper 3 months maintenance Abstinent 3 months + taper 2 mos f/u Weiss et al., 2011
  • 21.
    Among patients withan excellent 6 month response to treatment only 40% will remain in (free) treatment for 2 years Poor treatment retention is a major barrier to success for young adults Buprenorphine treatment in community settings Matson et al., 2014 Long‐Term Treatment with Buprenorphine/Naloxone in Primary Care: Results at 2–5 Years Fiellin et al., 2008
  • 22.
    Retention in treatment:long-term outcomes for MMT vs. BMT Retention in treatment is superior in optimized (flex dose) MMT vs BMT Patients started with BMT had lower treatment participation and higher opioid use during the 5-yrs as compared to patients treated with MMT At f/u close to 50% of patients were using opioids (less in MMT than BMT) Days of opioid use per month Hser et al., 2015 Patient retention in treatment
  • 23.
    Effectiveness of methadone(MMT) vs. buprenorphine (BMT) Retention in treatment (but not opioid use) is superior in optimized MMT vs BMT (e.g., flexible dose) MMT and BMT is similarly effective whether delivered in a primary care or outpatient clinic setting as compared to the specialized program Adjunct psychosocial and contingency interventions (e.g. financial incentives for opiate-free urines) enhance the effects of both MMT and BMT No significant differences in serious adverse effects for MMT compared with BMT some evidence suggests lower mortality with BMT vs. MMT Overall greater benefits for MMT may be balanced by better safety of BMT and preference of patients (Mattick et al., 2009, et al., 2001; Connock et al., 2007)
  • 24.
    Treatment with agonists:summary Two major medications that dominate the field Specialized treatment centers using methadone (MMT) Outpatient-based treatment using buprenorphine (OBOT) Strong and extensive evidence of effectiveness, conferring several major benefits BUT: Risk of harm Concerns about diversion Fail to keep patients in treatment over the long haul May limit patient’s involvement in recovery community Other agonist options: Buprenorphine XR (implant and injection) SR morphine Supervised heroin maintenance
  • 25.
  • 26.
    Opioid antagonist attachto the receptor and block other opioids from exerting any effects Naltrexone is a long-acting, high affinity, competitive opioid receptor antagonist with an active metabolite At sufficient blood levels naltrexone fully blocks all opioid effects Naltrexone tablet was approved in 1984 for the blockade of exogenously administered opioids Naltrexone injection (extended release, Vivitrol) was approved in 2010 for prevention of relapse following opioid detoxification Antagonist-based treatment
  • 27.
    The concept ofusing opioid blockers after detoxification to treat opioid addiction developed in parallel to methadone First introduced in 1970s as oral preparations, with disappointing results Difficulty with treatment initiation, low patient acceptability/adherence Reviews concluded that there is no evidence that naltrexone is effective beyond selected patient groups which discouraged its clinical use 1980s brought new developments: Clonidine found effective in treating withdrawal Development of naltrexone-assisted detoxification methods, an opportunity to continue with naltrexone as a relapse prevention agent Buprenorphine was introduced for detoxification Work with naltrexone continued in 1990-2000s Behavioral therapy was developed to improve adherence to oral naltrexone Long-acting preparations of naltrexone become available to overcome problems with non-adherence to oral preparations Brief History of Naltrexone-based Treatment
  • 28.
    Injections 1st gen: oilsuspension 2nd gen: microspheres with NTX in suspension (Vivitrol) licensed in 2007 Improving Treatment Retention Using Long-Acting Preparations Implants 1st gen compressed NTX c.1996, now licensed in Russia 2nd gen: NTX mixed with polymer matrix c. 2001
  • 29.
    Behavioral component: blockadeof the positive (reinforcing) effects of heroin leads to gradual extinction of drug seeking Patients who use while on naltrexone experience no effect and stop using Pharmacological component: naltrexone decreases reactivity to drug-conditioned cues and decreases craving thereby minimizing pathological responses contributing to relapse Patients on naltrexone have no urges to use Naltrexone Treatment: mechanism
  • 30.
    Requirement of detoxificationand a wait-period of 7-10 days after the last dose of an opioid before treatment can be initiated A major barrier for many patients who find difficult to tolerate withdrawal Further complicated by the reduction of inpatient/residential treatment programs Difficulty with the induction due to the possibility of precipitated or protracted withdrawal Patients do not feel well at the beginning of the treatment Requirement of close monitoring Antagonist-based Treatment: limitations
  • 31.
    Retention in treatmentis used as a primary outcome of treatment with NTX patients retained on NTX are mostly (90%) abstinent from opioids treatment drop-out is usually associated with relapse Treatment retention rate in groups treated with XR preparations is twice that of the oral group, approximating 50-70% at 6 months Efficacy of Naltrexone: oral vs. XR injection
  • 32.
    Efficacy of XR-Naltrexonevs. placebo Trials comparing injection of naltrexone vs. placebo showed that patients receiving active naltrexone have Better treatment retention Less opioid use Lower craving for opioids
  • 33.
    Efficacy naltrexone: summary Extended-releasepreparation(s) of naltrexone are more effective than the oral preparation and should be the treatment of choice Injection NXT can be supplemented with oral preparation if needed (e.g. delay in receiving injection) to maintain blocking blood levels XR preparation of naltrexone is a relatively new medication with limited effectiveness research to date There is less data available from controlled trials of XR-naltrexone as compared to methadone or buprenorphine No direct evidence yet available comparing efficacy of XR-naltrexone vs. buprenorphine Indirect comparisons show comparable treatment retention with lower level of ongoing opioid use No studies to suggest which patients will have a better response to XR-naltrexone vs buprenorphine Patient’s preference and clinical indications should determine the choice of medication
  • 34.
    Initiation of MAT: Patientand Medication Selection
  • 35.
    A range oftreatment goals Medically oriented treatment Protection against risk of OD and death Cessation of illicit opioid use (>90% negative toxicology) Improvement in physical and psychological health No dependence on other substances No misuse/diversion of medications Behaviorally oriented treatment Teach skills necessary to cope with cravings and life stressors without drugs The ultimate goal is to support long-term recovery to be maintained with or without medication sustained recovery with abstinence from all substances minimization of harms from ongoing use Opioid Dependence Treatment Goals
  • 36.
    Barriers to implementingMAT Lack of familiarity with the medications, limited training in addictions Resistance from the treatment community to change the standard approach (detox followed by “drug-free” program and AA/NA In 12-step community, using medication to support abstinence is considered unnecessary (even antithetical) for recovery Major rehabilitation programs “do not support use of medications” targeting addictions Cultural sentiment that addicts are best served by joining AA/NA However, standard approach is not only ineffective but dangerous Detoxified patients have elevated risk of overdose and death Detoxification not followed by the medication to prevent relapse should be considered a malpractice (iatrogenic death) maintaining an ineffective practice against the scientific evidence would not be acceptable in any other branch of medicine
  • 37.
    OTP Addiction Medicine/Psychiatry Practice Opioid User Inpatient Detoxification Unit Methadone Buprenorphine(OB) Naltrexone Residential Programs NaltrexoneBuprenorphine Psychosocial Only Current treatment system is fragmented into “one size fits all” silos Buprenorphine (DOT)
  • 38.
    Comprehensive Outpatient TreatmentProgram (HUB) Medication and Psychosocial Treatments Opioid User Methadone Buprenorphine (DOT) Residential Programs NaltrexoneBuprenorphine (OB) Addiction or Primary Care Outpatient Practice A comprehensive treatment program that offers multiple options “under one roof” allowing a smooth transition from one option to another according to patient’s needs
  • 39.
    Opioid Dependent Patients whoare NOT Physically Dependent YES Relapse Prevention CBT Support Groups NALTREXONE XR NO Relapse Prevention CBT Support Groups NALTREXONE P.O. PRN Returning to High Risk Environment Increased stress Persistent Craving
  • 40.
    Educate About TreatmentOptions Assess Patient’s Preference Assess Prognostic Factors Determine First-Line Treatment Abstinence Induction Using AGONIST Detoxification and Relapse Prevention Using ANTAGONIST NALTREXONE XR STABILIZATION Yes No METHADONE STABILIZATION BUPRENORPHINE STABILIZATION METHADONE MAINTENANCE NALTREXONE XR MAINTENANCE Yes Response Response BUPRENORPHINE MAINTENANCE No Yes Response Patients who are actively using No
  • 41.
    Choosing methadone vsbuprenorphine: factors to consider Interest in office vs. clinic-based treatment Ability to adhere to treatment/program rules Ability to follow safety procedures (e.g., monitor medication supply) Medical and psychiatric stability Use of other substances/severity of other SUDs Other medications that may interfere with one of the agonists What additional resources the patient need Additional support, stability of housing, employment History and response to previous treatments
  • 42.
    AGONIST ANTAGONIST Maintain physiologicaldependence/withdrawal on stopping + - Reinforcing effects promoting medication adherence ++ - Euphoric effects/abuse/diversion ++ - Potential for tolerance development +/- - Incompatible with ongoing illicit opioid use - + Protection against overdose (in adherent patients) + + May alter use of other drugs +/- ++ Duration of treatment Indefinite? ? Cultural/ideological barriers to availability ++ - Professional/public opposition ++ + Choosing AGONIST vs. ANTAGONIST
  • 43.
    Selection of candidatesfor naltrexone Patients who are not interested or able to be on agonist maintenance Patients who are detoxified and abstinent but at risk for relapse Patients who failed prior treatment with agonist Patients with less severe form of a disorder Young adults often unwilling to commit to a long-term agonist maintenance Individuals who use opioids sporadically Patients successful on agonist but who want to discontinue them without risking relapse
  • 44.
    Patients who maybe better candidates for agonists Patients with history of overdoses, particularly following detoxification Patients with serious psychiatric or medical problems Patients with limited social supports (unstable lives, homeless) Patients who have been opiate-free but never felt “normal” Patients with chronic pain requiring intermittent opioid treatment Patients with severe GI disorders exacerbating during withdrawal/abstinence Patients with advanced liver disease
  • 45.
  • 46.
    Early on methadonewas thought to be a tool to assist in recovery Emphasis of therapeutic alliance Recovering staff were role models High-dose and no limits on treatment duration As the treatment expanded and regulations were imposed the dominant approach shifted from recovery towards a “harm reduction” Focus on reduction in social costs (crime, infections) Decrease in ancillary services (for-profit programs) Reduction of methadone dose and the duration of treatment This turn away from the focus on recovery brought on another wave of criticism and public/professional stigma Can MAT be compatible with Recovery (White and Mojer-Torres, 2010)
  • 47.
    Reaffirmation of MMTeffectiveness by professional, scientific, and governmental organizations Advocacy efforts of MMT patients Accreditation of programs, focus on improving quality Understanding opioid addiction as a chronic disorder Emergence of recovery as an organizing paradigm Efforts to extend acute care model to models of recovery management (RM) & recovery-oriented systems of care (ROSC) Revitalization of MMT (1990-present) (White and Mojer-Torres, 2010)
  • 48.
    Betty Ford Institutedefinition of recovery “Recovery from substance dependence is a voluntarily maintained lifestyle characterized by sobriety, personal health, and citizenship” Was expanded to include patients treated with medications “…formerly opioid-dependent individuals who take naltrexone, buprenorphine, or methadone as prescribed and are abstinent from alcohol and all other nonprescribed drugs would meet this definition of sobriety” Recovery and medication status: BFI Consensus Statement (Betty Ford Institute 2007)
  • 49.
    Low attractiveness topatients Limited access/waiting lists Sub-therapeutic dosing and dose manipulation Premature administrative discharges, forced tapers High dropout rates, low rates of sustained engagement High-rates of post-discharge relapse and mortality Low engagement in recovery community Promoting role models/peer support Combatting professional/social stigma attached to MAT Engaging families in a sustained recovery-support process Recovery Management approach aims to address some of MAT limitations (White and Mojer-Torres, 2010)
  • 50.
    Utilize Strength-Based Management:building meaningful and satisfying lives Transition patients from professionally to a patient-directed recovery plan Expands the care team to include a variety of professionals Shift the treatment model from a directive expert model to a recovery partnership model (consideration for patient’s autonomy) Assure optimum duration of MAT (focus is on recovery not duration of medication tx) Expand the services within the vibrant culture of recovery (“Recovery is Contagious”) Extend delivery of recovery support services into the community (co-location) Proactively link patients/families to recovery community support resources Provide post-treatment monitoring, support and, early re-intervention if needed Recovery checkups & re-engagement Evaluate outcomes using (long-term) measures of recovery Global health, quality of life, community contribution Conduct anti-stigma campaigns RM approach seeks to: (White and Mojer-Torres, 2010)
  • 51.
    The role ofPCSS in improving access to MAT
  • 52.
    The Providers’ ClinicalSupport System for Medication Assisted Treatment is an initiative funded by SAMSHA in response to the opioid overdose epidemic PCSS-MAT is a national training and mentoring program developed to educate healthcare professionals on the use and availability of the latest pharmacotherapies What is PCSS-MAT?
  • 54.
    The overarching goalof PCSS-MAT is to make available educational and training resources on the most effective medication-assisted treatments Buprenorphine Naltrexone Methadone PCSS-MAT aims to reach providers who serve patients in a variety of settings, including primary care, psychiatric care, and pain management programs PCSS-MAT Goal and Target Audience
  • 55.
    PCSS-MAT Training Modalities PCSS-MAToffers no-cost training activities with CME to health professionals through the use of: Buprenorphine Waiver Trainings Naltrexone Trainings Webinars (Live and Archived) Online Modules Case Vignettes One-on-one and Small Group Discussions—clinical coaching In addition, PCSS-MAT offers a comprehensive library of resources Clinical Guidances and other educational tools Community Resources Listserv - Provides a “Mentor on Call” to answer questions about content presented through PCSS-MAT To join email: [email protected]
  • 56.
    PCSS-MAT Mentoring Program Designedto offer general information to clinicians about evidence- based clinical practices in prescribing medications for opioid addiction A national network of trained providers with expertise in medication- assisted treatment, addictions and clinical education Three-tiered mentoring approach allows every mentor/mentee relationship to be unique and designed to the specific needs of both parties The mentoring program is available at no cost to providers
  • 57.
    • 123 webinarsand online modules with 22,399 training participants • 212 Buprenorphine waiver trainings with 3,325 training participants • 55 mentors and 200 mentees and growing • 112 clinicians have participated in Small Group Discussions within mentoring program (new initiative starting 2015) PCSS-MAT Program Highlights
  • 58.
    Funding for thisinitiative was made possible (in part) by Providers’ Clinical Support System for Medication Assisted Treatment (grant no. 5U79TI024697) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government. PCSS-MAT is a collaborative effort led by American Academy of Addiction Psychiatry in partnership with: American Osteopathic Academy of Addiction Medicine, American Psychiatric Association, American Society of Addiction Medicine and Association for Medical Education and Research in Substance Abuse. For more information visit: www.pcssmat.org For questions email: [email protected] Twitter: @PCSSProjects
  • 59.
    Combination of MedicationAssisted Therapy and Behavioral Therapy: Key to Success
  • 60.
    Disclosure Statement • PhilWalls, RPh – Employment and ownership interest: Matrix HCS, Inc. • Michael Coupland, CPsych, RPsych CRC, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
  • 61.
    Learning Objectives • Explainthe role of medications in assisting recovery from opioid addiction. • Define keys to success when combining MAT and behavioral therapy. • Examine the differences in heroin use among patients receiving buprenorphine for opioid use disorders. • Provide accurate and appropriate counsel as part of the treatment team.
  • 62.
    Opioid Receptors • Threetypes of opioid receptors: – Mu receptors are responsible for interpretation of pain, analgesia, respiratory depression, physical dependence, and euphoria – Kappa receptors are responsible for modest analgesia, with little respiratory depression and little physical dependence – Delta receptors are not fully understood, however agonists show poor analgesia • Pharmacologic properties of opioids based on agonist or antagonist effects at the Mu and Kappa receptor sites.
  • 63.
    Agonist vs. Antagonist •Pure agonist has affinity for binding at receptor sites and activates receptors to produce effects • Pure antagonist has affinity for binding and occupying receptors but does not produce effect and therefore blocks agonists from binding • Mixed agonist-antagonist has affinity for binding at receptors but produces an agonist effect at one receptor and an antagonist effect at the other receptor
  • 64.
  • 65.
    Opioid Classification Drugs MuReceptor Kappa Receptor Pure Agonists Agonist Agonist Mixed Agonist- Antagonist Antagonist Agonist Pure Antagonist Antagonist Antagonist
  • 66.
  • 67.
    Drug Classification Agonists MixedAgonist- Antagonist Antagonists Morphine Pentazocine Naloxone Heroin Nalbuphine Naltrexone Hydromorphone Butorphanol Nalmephine Fentanyl Buprenorphine Codeine Oxycodone Methadone
  • 68.
  • 69.
    Response to theHeroin Epidemic The Centers for Disease Control and Prevention recommend: • Prevent people from starting heroin • Reverse heroin overdose • Reduce heroin addiction With regard to the latter, the CDC recommends that individuals addicted to heroin or prescription opioids have access to medication assisted treatment, which combines therapy with drugs like methadone, buprenorphine or naltrexone with counseling and behavioral therapy.
  • 70.
    Consider the Dangerof Misuse One tragic report comes from Kentucky where the state has been struggling to deal with first a prescription opioid epidemic and now a heroin epidemic like so many other states. Passage of House Bill 1 in 2012 by the Kentucky legislature wa designed to control pill mills and overprescribing of opioids, and achieved one goal: prescriptions for these drugs declined. However, the legislation did not put similar restrictions on prescriptions for buprenorphine. When used properly these drugs can help an addict quit using heroin without going through horrible withdrawal - however, one addict was quoted as saying: “it was just a great substitute for heroin. It was like doing the same thing, really.” The initial impact of HB 1 was to cause the state’s pill mills to turn into facilities that provided buprenorphine to addicts without any of the oversight necessary to truly help the patient.
  • 71.
    HB 1 InitiallyLed to a Surge in the Abuse of Buprenorphine
  • 72.
    High Cost ofa Proposed Cure
  • 73.
    In the workers’compensation area, most patient on long term opioids: Do not have pre-existing traits or behaviors indicative of addiction Take their opioids as prescribed and do not have aberrant drug screens, drug seeking behavior Have physicians who are unwilling to make changes to the prescribing patterns Prescribing physicians are willing to use psychologist support to assist patients to gain non pharmaceutical pain management skills and to increase function
  • 74.
    $ Chronic Pain & Disability Behavior$ Biopsychosocial Model of Chronic Pain Lifestyle: Exercise, Smoking, Alcohol and Drugs, Obesity / Diet Work Attachment / Age Depression / Anxiety Personality Disorders Hx of Childhood Abuse Perceived Injustice (retribution owed) Fear Avoidant Behavior (Guarding) Catastrophic Thinking Cortisol, substance p, serotonin, Norepinephrine, vasodilatation, vasoconstriction
  • 75.
    Dependence & ‘Addiction’ Neurobehavioral Effects ofOpioids Increase Noradrenaline to combat the depressive effects Turn off innate pleasure responses Release Dopamine (Pleasure) ***Tolerance Develops Demotivation, compromised ability to regulate unsafe behaviors Paired association of Pleasure with initiating reason for opioids Depress Breathing, Blood Pressure, Alertness
  • 77.
    Early Intervention Screening …..toassess risk for chronic pain, delayed recovery and opioid abuse
  • 78.
    Early Identification ofBioPsychoSocial Risk Factors 1. Psychosocial risk factors have been validated a. Meta Analyses b. Prospective studies c. Control group studies 2. A Pain Screening Questionnaire has been validated • Scores predict time loss / medical spend /function 3. Brief Cognitive Behavioral Therapy (CBT) interventions can successfully intervene • less time loss / medical spend /greater function
  • 79.
    Webster LR, WebsterRM. Pain Med. 2005;6(6):432-442. Misuse 40% Abuse: 20% Total Pain PopulationAddiction: 2% to 5% Prevalence of Misuse, Abuse and Addiction
  • 80.
    COPE with Pain CognitiveBehavioral Therapy (CBT)  CBT is brief and time-limited.  A sound therapeutic relationship is necessary for effective therapy, but not the focus.  CBT is a collaborative effort between therapist and client.  CBT is based on stoic philosophy.  CBT is structured and directive.  CBT is based on an educational model.  Homework is a central feature of CBT.
  • 81.
    How to TreatPsychosocial Factors without ‘Buying’ an unwarranted Psych Claim The new ‘health and behavior assessment and intervention’ codes ensure the claimant does not become further ‘medicalized’ Psychiatric diagnosis and treatment codes are NOT used unless there is already a mental health accepted diagnosis CPT Code Descriptor 96150 Initial assessment to determine biological, psychological and social factors affecting health and any treatment problems 96151 Reassessment to evaluate condition and determine need for further treatment
  • 82.
    Treatment RTW Outcomes Control GroupIntervention Group High Risk and Very High Risk High Risk Very High Risk Sample Size 36 62 109 % claims closed at 26 weeks 33% 76% 62% % working at 26 weeks 17% 68% 39% Avg claim duration at 26 weeks 24 weeks 18.7 weeks 20.2 weeks Coupland, M., Margison, D. Early Intervention in Psychosocial Risk Factors for Chronic Pain, Musculoskeletal Disorders and Chronic Pain Conference, Feb 2011, Los Angeles, CA
  • 83.
    Treatment High Risk vs.Low Risk Psychosocial • 9% Fewer Pt. get Physical Therapy • 10% Fewer Pt. get Imaging Studies • 13% Fewer Pt. get Injections • 6% Fewer Pt. get Surgeries • 5% More Pt. get Vocational Rehabilitation Outcomes @26 wks+ Coupland, M., Margison, D. Early Intervention in Psychosocial Risk Factors for Chronic Pain, Musculoskeletal Disorders and Chronic Pain Conference, Feb 2011, Los Angeles, CA
  • 84.
  • 85.
    Are Patients ReceivingBuprenorphine for Opioid Use Disorders Different in Important Ways if they Used Heroin? Robert L. DuPont, M.D., President Institute for Behavior and Health, Inc. www.ibhinc.org Katherine Garcia-Rosales, B.S., Faculty Research Assistant Center for Substance Abuse and Research www.cesar.umd.edu
  • 86.
    Disclosure • Robert L.DuPont, M.D. wishes to disclose that he was Vice President of Bensinger, DuPont & Associates (1982-2015) and Chairman of its subsidiary Prescription Drug Research Center (2003-2015). Content will be presented in a fair and balanced manner. • Katherine Garcia-Rosales, B.S. has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
  • 87.
    Workshop Learning Objectives 1.Explain the role of medications in assisting recovery from opioid addiction 2. Define keys to success when combining MAT and behavioral therapy 3. Examine the differences associated with heroin use by patients receiving buprenorphine for opioid use disorders 4. Provide accurate and appropriate counsel as part of the treatment team.
  • 88.
    The Clinical Challenge •To distinguish between patients who use opioids as prescribed and those who use them nonmedically, often with other drugs, and/or divert them to other drug users • This is difficult because addicted patients and those diverting drugs lie; physicians are not good at recognizing dishonest patients
  • 89.
    A Crucial Distinction: Addictionvs. Physical Dependence • Addiction has two key features: – Continued use despite problems – Dishonesty • Addiction seldom involves only one drug whereas physical dependence without addiction almost always does involve only one drug • The treatment of addiction is medically challenging and lifelong
  • 90.
    Physical Dependence • Thebody’s adaptation to chronic use of a specific drug or related class of drugs, e.g., opioid dependence • Withdrawal, when the drug is abruptly stopped, is commonly associated with a reversal of the effects of the drug and is often intensely unpleasant • Treatment for physical dependence is gradual dose reduction and usually relatively brief
  • 91.
    Today’s Presentation • Exploresthe context of the heroin epidemic • Focuses on one important new finding among patients being treated for opioid dependence • Those who have used heroin are different from those who have not used this drug • This difference matters for both prevention and treatment
  • 92.
    • Round onewith heroin was from 1898 to 1914 – Heroin over-the-counter – Rural, middle aged and mostly female • Round two was from 1970 to 1978 – Both heroin use and sale linked to urban crime – Mostly minority young men • Round three is ongoing today – In the context of massive use of prescription opioids – Profound improvement in heroin distribution – easier to get, more potent and far cheaper Recurring Heroin Epidemics in the US DuPont, 1971; DuPont & Greene, 1973; CDC 2015
  • 93.
    Long-Term Changes inHeroin Use • Demographics of heroin addiction/treatment have changed over the last 50 years – From an inner-city, minority criminal problem – To a wider geographical distribution, involving primarily white men and women in their 20s and 30s living in suburban and rural areas • Heroin use in the general population is rare compared to many other drugs • The number of new heroin users is increasing and overdose deaths are rising dramatically Cicero, et al., 2014; Center for Behavioral Health Statistics and Quality (CBHSQ) 2015
  • 94.
    Rx Opioid-Heroin UseConnection • During the 1960s heroin epidemic users often chose heroin as their first drug • Now most heroin users previously used prescription opioids nonmedically before starting heroin use • Before today’s heroin users first used prescription opioids, most used other drugs of abuse, often starting in adolescence Jones, 2013; Cicero, 2014
  • 95.
    Today’s “Round Three”– Initiation to Opioid Use • In 2014, there were 1.4 million initiates to nonmedical use of prescription pain relievers – Lower than in recent years – Average age of first use 21.2 years • 212,000 initiates to heroin – Significantly higher than in 2006 (90,000 initiates) – Average age of first use 28 years SAMHSA, 2014; CBHSQ, 2015
  • 96.
    National Changes inDrug Overdose Deaths per 100,000 2003-2014 Park & Bloch, 2016
  • 97.
    Age-Adjusted Rates ofDeath Related to Rx Opioids and Heroin Drug Poisoning in the US, 2000-2015 Data from CDC reported in Compton, Jones, & Baldwin, 2016
  • 98.
    Nonmedical Use ofPrescription Opioids and Heroin During the Previous Year Among Persons 12 Years of Age or Older, 2002-2014 Data from CBHSQ reported in Compton, Jones, & Baldwin, 2016
  • 99.
    Why the DramaticRise in Heroin Use and Overdose Deaths NOW? • Rise in prescription opioid use • Dramatic improvements in the heroin supply Compton, Jones, & Baldwin, 2016
  • 100.
    It’s the Supply,Stupid! • Heroin is delivered anonymously to your door ordered by phone or online • Low cost and high potency of heroin • Implications for drug policy and the role of the criminal justice system
  • 101.
    New Research Questions •How can physicians identify prescription opioid patients at risk for transitioning to heroin? • How are patients with opioid use disorders who use heroin different from those who do not?
  • 102.
    Persons Receiving Buprenorphinefor Outpatient Treatment of Opioid Disorders: Are They Different If They Also Used Heroin? Garcia-Rosales, K., and Wish, E. D. Persons Receiving Buprenorphine for Outpatient Treatment of Opioid Disorder: Are They Different if They Also Used Heroin? 21st Annual University at Buffalo Undergraduate Research Conference and 11th Annual Graduate School Opportunities Program, July 23-25, 2015; Bioscience Day at University of Maryland, November 19, 2015
  • 103.
    Methodology Research Design: • Secondaryanalysis of existing data from 157 patients who enrolled in an outpatient treatment program in the Maryland- Washington D.C. area who were being prescribed buprenorphine • Quasi-experimental design comparing patients classified by self-reported heroin and prescription opioid use
  • 104.
    Instrument Instrument: Self-administered semi-structured questionnaire developedby IBH: • Demographics • Self-reported lifetime use of: illegal drugs (marijuana, PCP, heroin) and Rx opioids (buprenorphine, methadone, OxyContin/other Rx opioids)
  • 105.
    • Majority ofthe sample were males and almost half were below age 30 • Half or more used OxyContin/other Rx opioids or buprenorphine without a prescription • About 1/4 (26%) had used methadone without a prescription
  • 106.
    • Only 6%(9 persons) reported using heroin only • The analyses that follow compare: - 80 persons (51%) who had used Rx opioids with or without a prescription and heroin with - 68 persons (43%) who had used Rx opioids with or without a prescription only
  • 107.
    • Users ofRx opioids + heroin: - were younger than those who had not used heroin - began using Rx opioids before heroin - initiated Rx opioid use earlier than the non-heroin users • 2/3 (66%) of the Rx opioids + heroin users had used Rx opioids for the first time before age 20
  • 108.
    • Users ofRx opioids + heroin were much more likely to have used multiple drugs; 79% vs. 30% used three or more drugs • Only 6% of the Rx opioids + heroin users used only one additional drug
  • 109.
    Limitations • Sample likelynot representative of the whole population in treatment with buprenorphine • Sole reliance on self-reported drug use • Limited information collected about study participants
  • 110.
    Summary of Findings •In this population of patients, there were two distinct groups of patients who were identified based on past history of heroin use • Persons receiving buprenorphine for treatment of opioid disorder who used Rx opioids + heroin were more likely to misuse other drugs, to have begun use earlier, and to engage in polydrug use • Only a small minority (6%) who used Rx opioids + heroin were not polydrug users and might be the new kind of heroin users thought to be produced by the current epidemic of prescription opioid misuse
  • 111.
    Study Implications • Physiciansand health workers should capture an extensive drug use history from patients being treated for opioid use disorders • Urine drug tests could be used to enhance self- reported drug use history information • Patients who have used heroin are likely to need special interventions targeted at their polydrug use • Effective treatment needs to fully address the patient’s entire drug problem
  • 112.
    Few Nonmedical RxOpioids Users Transition to Heroin • Nationally, only a small subset of people who started using prescription pain relievers non- medically transitioned to heroin within 5 years Initiated Non-Medical Use of Pain Relievers (10 million over 5 years) Initiated Heroin Use (500,000 over 5 years) 20% of Recent Heroin Initiates Did Not Previously Use Prescription Pain Relievers Only 3.6% of Initiates to Non-Medical Use of Pain Relievers (360,000) Transitioned to Heroin 80% of Recent Heroin Initiates Previously Used Prescription Pain Relievers Muhuri, Gfroerer, & Davies, 2013
  • 113.
    Individuals Who Usethe Less Prevalent Drugs are Most Likely to Use Many Drugs Provided by the Center for Substance Abuse Research
  • 114.
    Implications for Preventionand Treatment • Not every dependent prescription opioid user is at risk to switch to heroin • To prevent a switch to heroin, pain management physicians need to focus on patients who are long-time heavy users of alcohol and other drugs of abuse
  • 115.
    Additional Thoughts on OpioidAddiction Treatment • Medications only work while they are taken • Opioid dependence is a life-long disease • Most forms of treatment, including opioid substitution therapy (OST), is short-term • OST has no effect on the use alcohol or other drugs • What happens to opioid addicts when they leave OST?
  • 116.
  • 117.
    Institute for Behaviorand Health, Inc. • IBH is a 501(c)3 non-profit organization that develops strategies to reduce drug use • For more information and resources, visit the IBH websites: www.IBHinc.org www.StopDruggedDriving.org www.PreventTeenDrugUse.org www.PreventionNotPunishment.org
  • 118.
    Center for SubstanceAbuse Research • The Center for Substance Abuse Research (CESAR), at the University of Maryland at College Park, is dedicated to addressing the problems substance abuse creates for individuals, families, and communities • For more information and resources, visit the CESAR websites: www.cesar.umd.edu www.ndews.umd.edu
  • 119.
    References • Centers forDisease Control and Prevention. (2015, July 7). Today’s heroin epidemic. Atlanta, GA: CDC. Available: http://www.cdc.gov/vitalsigns/heroin/index.html • Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H- 50). Available: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf • Cicero, T. J., Ellis, M. S., Surratt, H. L., & Kurtz, S. P. (2014). The changing face of heroin use in the United States. JAMA Psychiatry, 71(7), 821-826. • Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid use and heroin use. New England Journal of Medicine, 374, 154-163. • DuPont, R. L. (1971). Profile of a heroin-addiction epidemic. New England Journal of Medicine, 285, 320-324. • DuPont, R. L. & Greene, M. H. (1973). The dynamics of a heroin addiction epidemic. Science, 181, 716-722. • Jones, C. M. (2013). Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers—United States, 2002-2004 and 2008-2010. Drug and Alcohol Dependence, 132, 95-100. • Muhuri, P. K., Gfroerer, J. C., & Davies, M. C. (2013). Associations of non-medical pain reliever use and initiation of heroin use in the United States. CBHSQ Data Review. Rockville, MD: Substance Abuse and Mental Health Services Administration. • National Institute on Drug Abuse. (2015, December). Overdose death rates. Rockville, MD: Author. Available: http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates • Park, H. & Bloch, M. (2016, January 19). How the epidemic of drug overdose deaths ripples across America. New York Times. Available: http://www.nytimes.com/interactive/2016/01/07/us/drug-overdose-deaths-in-the-us.html • Substance Abuse and Mental Health Services Administration. (2014).Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration. Available: http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.htm
  • 120.
    Additional Reading • Centersfor Disease Control and Prevention. (2014, October 2). Heroin overdose deaths increased in many states through 2012; still twice as many people died from prescription opioid overdoses. CDC Newsroom. Atlanta, GA: CDC. Available: http://www.cdc.gov/media/releases/2014/p1002-heroin-overdose.html • Centers for Disease Control and Prevention. (2015, July 7). Today’s heroin epidemic. CDC Vital Signs. Atlanta, GA: CDC. Available: http://www.cdc.gov/vitalsigns/heroin/ • Centers for Disease Control and Prevention, Division of News & Electronic Media, Office of Communications. (2013, February 20). Opioids drive continued increase in drug overdose deaths. Press Release. Atlanta, GA: CDC. Available: http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html • Centers for Disease Control and Prevention, National Center for Health Statistics. (2015, June 12). NCHS data on drug poisoning facts. NCHS Fact Sheet. Atlanta, GA: CDC. Available: http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.htm • Chou, R., Turner, J. A., Devine, E. B., et al. (2015). The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways workshop.Annals of Internal Medicine. doi:10.7326/M14-2559 Available: http://annals.org/article.aspx?articleid=2089370 • Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid use and heroin use. New England Journal of Medicine, 374, 154-163. • Frenk, S., Porter, K., Paulozzi, L. (2015) Prescription Opioid Analgesic Use Among Adults: United States 1999- 2012. NCHS Data Brief, No. 189. Available: http://www.cdc.gov/nchs/data/dataBriefs/db189.pdf • Hedegaard, H., Chen, L., Warner, M. (2015) Drug-poisoning Deaths Involving Heroin: United States, 2000- 2013. NCHS Data Brief, No. 190. Available: http://www.cdc.gov/nchs/data/databriefs/db190.pdf
  • 121.
    • Jones, C.M. (2012a). Prescription Drug Abuse and Overdose in the United States, presented at Third Party Payer and PDMP Meeting, December 2012. Available: http://www.pdmpexcellence.org/sites/all/pdfs/Jones.pdf • Jones C. M. (2012b). Frequency of prescription pain reliever nonmedical use, 2002-2003 and 2009-2010. Archives of Internal Medicine, 172(16), 1265-1267. • National Institute on Drug Abuse. (2014, October). Heroin. DrugFacts. Rockville, MD: Author. Available: http://www.drugabuse.gov/publications/drugfacts/heroin • New York Times Editorial Board. (2015, March 2). Painkiller abuses and ignorance. New York Times, p. A18. • Rudd, R. A., Paulozzi, L. J., Bauer, M. J., et al. (2014, October 3). Increase in heroin overdose deaths – 28 states, 2010 to 2012. Morbidity and Mortality Weekly Report, 63(39), 849-854. • SAMHSA National survey of substance abuse treatment services. 2006. Found at: http://wwwdasis.samhsa.gov/webt/state_data/US06.pdf. • Sheir, R. (2014, November 21). Meet the man who tackled D.C.’s first heroin epidemic. WAMU 88.5 Metro Connection. Available: http://wamu.org/programs/metro_connection/14/11/21/meet_the_man_who_tackled_dcs_first_heroin_e pidemic • Volkow, N. (2014, May 14). America’s Addiction to Opioids: Heroin and Prescription Drug Abuse. Presented to the Senate Caucus on International Narcotics Control. Available: http://www.drugabuse.gov/about- nida/legislative-activities/testimony-to-congress/2014/americas-addiction-to-opioids-heroin-prescription- drug-abuse • Wood, G. (2014, March 19). Drug dealers aren’t to blame for the heroin boom. Doctors are. New Republic. Available: http://www.newrepublic.com/article/116922/what-makes-heroin-crisis-different-doctor- prescribed-pills
  • 122.
    Medication-Assisted Treatment Presenters: • AdamBisaga, MD, Professor of Psychiatry, Columbia University Medical Center • Phillip Walls, RPh, Chief Clinical Officer, myMatrixx • Michael Coupland, MA, RPsych, Network Medical Director, IMCS Group • Robert L. DuPont, MD, Founding President, Institute for Behavior and Health, Inc. • Katherine Garcia-Rosales, BS, Research Assistant, Center for Substance Abuse Research, University of Maryland College Park Pre-Summit Workshop Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA, President- elect, American Society of Addiction Medicine, and Member, Rx and Heroin Summit National Advisory Board