Medication Assisted Treatment Georgia Statewide Conference September 12 th, 2016

Transcription

1 Medication Assisted Treatment Georgia Statewide Conference September 12 th, 2016 Laurence M. Westreich, M.D. Associate Professor of Clinical Psychiatry Division of Alcoholism and Drug Abuse Department of Psychiatry New York University School of Medicine

2 Learning Objectives 1. Understand the biological basis for addiction and substance use disorders. 2. Identify goals for treatment. 3. Know the medications currently FDA-approved for the treatment of Opioid Use Disorders. 4. Understand the key indications and contraindications for medications used to treat Opioid Use Disorders. 5. Recognize how physicians decide on treatment changes and reduce the risk of diversion.

3 This is Your Brain on Drugs 3

4 Substance Use Disorder Addiction A substance use disorder describes a problematic pattern of using alcohol or another substance that results in impairment in daily life or noticeable distress. A person with this disorder will often continue to use the substance despite consequences. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. American Psychiatric Association. Arlington, VA 2013 p

5 The person must have at least two of the following for a given substance within the same 12-month period: Drinking or using a drug in an amount that is greater than the person originally sets out to consume (or using over a longer period of time on a given occasion). Worrying about cutting down or stopping; or unsuccessful efforts to control use. Spending a large amount of time using a substance, recovering from it, or doing whatever is needed to obtain it. Common use of a substance resulting in (1) failure to take care of things at home, work, school (or to fulfill other obligations); and/or (2) giving up once-enjoyed recreational activities or hobbies. Craving, a strong desire to use alcohol or another substance. Continuing the use of a substance despite problems caused or worsened by it (1) in areas of mental (e.g., blackouts, anxiety) or physical health; or (2) in relationships (e.g., using a substance despite people s objections or it causing fights or arguments). Recurrent alcohol/substance use in a dangerous situation (such as driving or operating machinery). Building up tolerance as defined by either needing to use noticeably larger amounts over time to get the desired effect or noticing less of an effect over time after repeated use of the same amount. Experiencing withdrawal symptoms (e.g., anxiety, irritability, fatigue, nausea/vomiting, hand tremor or seizure in the case of alcohol) after stopping use. 5

6 Dependence Building up tolerance as defined by either needing to use noticeably larger amounts over time to get the desired effect or noticing less of an effect over time after repeated use of the same amount. Experiencing withdrawal symptoms (e.g., anxiety, irritability, fatigue, nausea/vomiting, hand tremor or seizure in the case of alcohol) after stopping use. 6

7 What is the Goal of Addiction Treatment? Abstinence from the Substance of Abuse? Abstinence from all Substances of Abuse? Decreased use of the Substance of Abuse? Harm Reduction? Improvement in Psychosocial Variables? (Work, school, relationships) Improvement in Physical Health? Improvement in Mental Health? 7

8 How Can We Measure The Efficacy of Addiction Treatment? Abstinence from the substance of abuse at 6 months? 12 months? One year? Improvement in Psychosocial Variables? (Work, school, relationships) Improvement in Physical Health? Improvement in Mental Health? 8

9 Psychotherapy Approaches to Addiction Motivational Interviewing Cognitive-Behavioral Therapy Family Structural Therapy Contingency Management Strategies Mindfulness Therapy

10 Narcotics Anonymous

11 Phases of Substance Use That Are Targets for Medications Intoxication/overdose Withdrawal/detoxification Abstinence initiation/use reduction Relapse prevention Sequelae (psychosis, agitation, etc.)

12 Tapering vs. Maintenance 12

13 Medications for Substance Use Disorders Alcohol Opiates Acute withdrawal Relapse prevention (ongoing pharmacotherapy) Overdose Acute withdrawal Relapse prevention Cocaine and Marijuana Facilitating Abstinence/Relapse Prevention Co-Occurring mental illness and psych medications (Nicotine)

14 When to Consider Medications Assess patient for: for SUDs Severity of Concomitant Medical Illness: Patient s ability to tolerate medication? Pregnancy: opioid therapy should be offered to pregnant opioid/heroin addicts; medications that can be associated with adverse physical effects should be avoided (e.g. disulfiram (Antabuse) Phase of Recovery: Medications for medical withdrawal or medication to assist with maintenance of abstinence following withdrawal

15 Some Medication Treatment Strategies for SUD Agonist (replacement/substitution) Antagonist (blockade) Aversive (negative reinforcement) Treatment of underlying/associated disorders (such as depression, etc.)

16 Substances for which Medications are FDAapproved Opioids Alcohol Benzodiazepines Tobacco (nicotine dependence) Substances for which Medications are NOT FDAapproved Cocaine Methamphetamine Hallucinogens Cannabis Solvents/Inhalants

17 Medications for Opiate Dependence Methadone Buprenorphine Naltrexone

18 Opioid Dependence Therapy: Agonist Treatment What is agonist therapy? Use of a long acting medication in the same class as the abused drug (once-daily dosing) Prevention of Withdrawal Syndrome Induction of Tolerance What agonist therapy is not: Substitution of one addiction for another CSAT, 2005

19 Opioid Dependence Therapy: Agonist Treatment Who is appropriate for methadone therapy? > 18 years (exceptions for y.o. with parental consent and special methadone treatment programs) Greater than 1 year of opioid dependence Medical compromise Infectious disease Pregnancy CSAT, 2005

20 Opioid Dependence Maintenance Therapy Diagnose Opiate Use Disorder History (including previous records) Signs of dependence (withdrawal symptoms, tracks) Urine toxicology ECG (methadone only) Naloxone challenge can be given if unsure of opioid dependence Clinical Opiate Withdrawal Scale (COWS) can be used to determine extent of opiate withdrawal symptoms

21 Maintenance Therapy with Methadone Methadone (must be administered through a registered narcotic treatment program) Characteristics Long acting mu agonist Duration of action: h Dose: important issue and philosophical issue for many programs mg will block withdrawal, but not craving Illicit opiate use decreases with increasing methadone dose mg is more effective at reducing opioid use than lower doses (e.g.: mg/d) Strain et al., 1999

22 Maintenance Therapy with Methadone Benefits: Lifestyle stabilization Improved health and nutritional status Decrease in criminal behavior Employment Decrease in injection drug use/shared needles Downsides: Overdose possible Oversedation possible Withdrawal EKG changes Diversion Meaning of maintenance treatment CSAT, 2005

23 What is the Drug Abuse Treatment Act of 2000? Title XXXV, Section 3502 of the Children s Health Act of 2000 This act permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication. Such medications may be prescribed and dispensed by waived physicians in treatment settings other than the traditional Opioid Treatment Program (methadone clinic) setting. 23

24 Maintenance Therapy With Buprenorphine Buprenorphine/Naloxone)(Suboxone) Characteristics Partial, long acting mu agonist Duration of action: h Dose: Range from 8-32 mg- SL New formulations, dosing is slightly different- buccal patch Strain et al., 1999

25 Maintenance Therapy with Buprenorphine Benefits: Lifestyle stabilization Can be provided in a doctor s office by someone licensed to prescribe it Available by prescription Withdrawal more easily tolerated One physician for patients with multiple illnesses Downsides: Diversion (+/-) Withdrawal Meaning of maintenance treatment CSAT, 2005

26 The Ceiling Effect* Ceiling on the mu-opioid agonist effects of buprenorphine, a partial agonist, in contrast to the more linear relationship between dose and agonist effect observed with methadone *Maremmani I, Gerra G: Buprenorphine-based regimens and methadone for the medical management of opioid dependence: selecting the appropriate drug for treatment. Am J Addict 2010;19:

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28 Primary Care-Based Buprenorphine Taper vs Maintenance Therapy for Prescription Opioid Dependence: A Randomized Clinical Trial Design, Setting, and Participants We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17, 2009, through February 1, 2013, in a single primary care site. Conclusions and Relevance Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care. David A. Fiellin, MD, et. al 28

29 Naltrexone Opioid Dependence Therapy: Why antagonist therapy? Antagonist Treatment Block effects of a dose of opiate (Walsh et al. 1996) Prevent impulsive use of drug Relapse rates high (90%) following detoxification with no medication treatment Dose (oral): 50 mg daily, 100 mg every 2 days, 150 mg every third day Blocks agonist effects Side effects: hepatotoxicity, monitor liver function tests every 3 months Biggest issue is lack of compliance; but those who test naltrexone by taking a dose of opioid and experiencing no effect do better with the medication (Cornish JW, et al. 1997) Injectable naltrexone provides a viable alternative, higher compliance rates Clinical lore that not as effective as buprenorphine but that may not be the case if using injectable formulation

30 Who is a Candidate For Naltrexone? The patient is opioid free for 7-10 days (this may not be necessary based on ongoing work at Columbia) The patient does not have severe or active liver or kidney problems (Typical guidelines suggest liver function tests no greater than 3 times the upper limits of normal, and bilirubin normal) The patient is not allergic to naltrexone, and no other contraindications are present (rarely would someone be allergic to naltrexone, but opioid addicted individuals sometimes may report an allergy as this is not a preferred treatment or they may have started naltrexone before being completely withdrawn from opioids and experienced precipitated withdrawal ask patient about the time frame of adverse events when trying to evaluate)

31 Reluctance to Prescribe Medications for Addiction Lack of available prescribing providers Concerns about psychological issues: overreliance on medications Concerns about enabling Concerns about medication safety and related issues

32 Principles of Effective Treatment According to National Institute of Health (NIH) Addiction is a complex but treatable disease that affects brain function and behavior. No single treatment is appropriate for everyone. Treatment needs to be readily available. Effective treatment attends to multiple needs of the individual, not just his or her drug abuse. Remaining in treatment for an adequate period of time is critical. Counseling individual and/or group and other behavioral therapies are the most commonly used forms of drug abuse treatment. Medications are an important element of treatment for many patients, especially when combined with counseling and other behavioral therapies. 32

33 Principles of Effective Treatment (According to the National Institute of Health, NIH) (Part 2) Many drug addicted individuals also have other mental disorders. An individual's treatment and services plan must be assessed continually and modified as necessary to ensure that it meets his or her changing needs. Medically assisted detoxification is only the first stage of addiction treatment and by itself does little to change long term drug abuse. Treatment does not need to be voluntary to be effective. Drug use during treatment must be monitored continuously, as lapses during treatment do occur. Treatment programs should assess patients for the presence of HIV/AIDS, hepatitis B and C, tuberculosis, and other infectious diseases as well as provide targeted risk reduction counseling to help patients modify or change behaviors that place them at risk of contracting or spreading infectious diseases. 33

34 The Spectrum of Addiction Treatment Voluntariness Informal Pressure Formal Intervention, Criminal Penalties, Patient sentenced to prison Civil Commitment Friends enters treatment with less penalty Boot Camp/DWI Jail after volunteering Family penalty for leaving treatment in lieu of prison Employer DUI Drug Possession Breath/Urine Monitoring, Loss of Benefits if no Probation/Parole Patient Imprisoned Patient adjudicated treatment changes Cooperation With Treatemnt if participating Reduced Sentence for incompetent because on results public housing in treatment in-prison treatment of drugs/alcohol, program committed involuntarily Adapted from Blume S, Involuntary Treatment for Substance Use Disorders, Unpublished Paper, 1999

35 Safe Prescription of Potentially Addictive Medications 35

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37 Red Flags for Misuse or Diversion* Symptoms of intoxication or symptoms associated with heavier use (agitation, agitation, psychosis, SOB, palpitations) Demands for a particular, usually fast acting, medication (amphetamine IR) Extended-release doesn t work for me Repeated lost prescriptions Discordant pill count (escalation of doses) Excessive preoccupation with securing medication supply Multiple prescribers *Slide courtesy Frances Levin, M.D.

38 Prescribing Medications with Potential for Addiction* Misuse/Diversion/Abuse/Addiction are inherent risks of prescribing controlled substances A risk assessment has to be conducted for a specific patient at a specific time All patients prescribed controlled substances should be assessed at each visit for signs of misuse or addiction Ask questions using a matter-of-fact and non-threatening manner Be aware of counter-transference *Slide courtesy Frances Levin, M.D. 38

39 Where Can Physicians Receive DATA-2000 Qualifying Training? American Academy of Addiction Psychiatry American Osteopathic Academy of Addiction Medicine American Psychiatric Association American Society of Addiction Medicine 39

40 Take Home Points Addiction is a biological disease Three medications are FDA-approved for treatment of opioid addiction: naltrexone (an opioid antagonist best for highly motivated patients), methadone (must be given through a licensed narcotic treatment program), and buprenorphine/naloxone (available by prescription from qualified providers). These medications are appropriate adjuncts and should be considered part of the toolbox for treating addictions.

41 References Primary Care Based Buprenorphine Taper vs Maintenance Therapy for Prescription Opioid Dependence: A Randomized Clinical Trial JAMA Intern Med. 2014;174(12): doi: /jamainternmed The Neurobiology of Opioid Dependence: Implications for Treatment, Thomas Kosten, MD, Tony George, MD Naltrexone Information Sheet l 41

42 Case History # 1 32 YO male Long history of polysubstance use Marijuana dealer Daily marijuana use Occasional intranasal opioid use Facing incarceration for drug dealing 42

43 Case History # 2 21 YO female College sophomore On probation for prostitution arrest 3 year history of intranasal/intravenous heroin use 4 28-day rehab stints Hepatitis C positive Profound mood instability Poor response to antidepressant medication 43

44 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, and American Society of Addiction Medicine. For more information visit: For questions pcssmat@aaap.org 44

45 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry in partnership with: Addiction Technology Transfer Center, American Academy of Neurology, American Academy of Pain Medicine, American Academy of Pediatrics, American College of Physicians, American Dental Association, American Medical Association, American Osteopathic Academy of Addiction Medicine, American Psychiatric Association, American Society for Pain Management Nursing, International Nurses Society on Addictions, and Southeast Consortium for Substance Abuse Training. For more information visit: For questions pcss-o@aaap.org 45

46 Laurence M. Westreich, M.D (Office) (Cell) 46