Implementing Medication Assisted Treatment for OUD

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1 Implementing Medication Assisted Treatment for OUD Arthur Robin Williams MD MBE Fellow, Columbia University Department of Psychiatry Division on Substance Use Disorders Nick Szubiak, MSW, LCSW Director of Clinical Excellence in Addictions National Council for Behavioral Health NatCon17 Seattle, Washington April 2017

2 Disclosures Arthur Robin Williams, MD, MBE receives grant funding from NIDA and compensation as a consultant to: American Academy of Addiction Psychiatry (AAAP) National Council for Behavioral Health (NCBH) 1

3 Implementing Medication Assisted Treatment for OUD Who: National Council for Behavioral Health and American Academy of Addiction Psychiatry (AAAP) with support from Open Society Foundations (OSF)

4 Implementing Medication Assisted Treatment for OUD What: Learning Community When: October Where: 6 behavioral health organizations Why: To support the use of MAT as an adjunct to behavioral health treatment for addiction How: 12 months of technical assistance

5 The Six Participating Organizations EASTERN SHORE PSYCHOLOGICAL SERVICES Community Health Network Indianapolis, Indiana

6 The Six Participating Organizations Advantage Behavioral Health System Athens, Georgia Community Health Network, Indianapolis, Indiana Southwest Counseling Service, Sweetwater, Wyoming Terry Reilly Health, Boise, Idaho Services Eastern Shore Psychological Services Salisbury, Maryland Bridgeway Behavioral Health, St. Charles, Missouri

7 What is a Learning Community? Developed the RFA Data? Infrastructure? Motivation? Community? Technical Assistance Monthly Webinar Affinity Group calls 1:1 Coaching Curated Resource s Site Visit Develop relationships and a sense of community Trust Vulnerability Sharing Knowledge Creativity Fun Mission and Vision Impact Areas Evidenced Based Practices, operational workflows, clinical protocols and pathways, overcoming challenges Not just About MAT Organizational Change Population Health Management

8 Overcoming Challenges Bias and Discrimination Understanding Substance Use Disorders Understanding Recovery Understanding MAT Policy Protocols How WE do this Organizational Change

9 Medication Assisted Treatment: Lessons Learned from the Field MAT utilization increased in all of the participating organizations Increased the number of clients served by MAT from 5 to 71 Key Organizational Successes: Demonstrated a 286.6% increase in Vivitrol prescriptions First provider in their area to offer MAT as an evidence-based treatment for SUDs Forged a strong relationship with their criminal justice system to offer MAT to incarcerated clients and connect them to services upon return to the community Data shows that organizations across the learning community saw marked increases in staff s comfort with Suboxone and Naltrexone/Vivitrol These organizations were champions for culture change, addressing attitudinal barriers about MAT among staff and organizational culture, which so often is the first step to sustainable organizational change

10 MAT Questions for Dr. Williams 1. Is MAT effective for the majority of people struggling with alcohol or opioids use disorders? 2. What is the role of MAT in the treatment of SUDs? How does it fit in with existing treatment models and programs? Does MAT work with the recovery model and is it part of recovery if someone is using a drug to stay sober? Can you be in recovery and on MAT? 3. Can you explain the difference Buprenorphine,, Naloxone, Naltrexone, and? (Are there any ways or techniques I can learn to keep these straight as I think about them?) 4. What are the dangers of the MAT medications like long term effects? How safe are this medications relative to other behavioral health medications? There has been a lot of publicity around substance use being a brain disorder and that this needs to be part of the formal definition of addiction. And some of the work force in physical and behavioral health as well as clients and their families are known to say we don t really know what addiction is. 5. How about genetics? Is there a genetic component to substance use disorders? 6. We are starting to recognize more and more how behavioral health issues like early childhood experiences, trauma, and other behavioral health issues impact people and substance use. How do these factors impact the use of MAT? (Discuss role of BH support with MAT, MAT supports the recovery plan) 7. How quickly should providers get their clients off of MAT? Should providers urge their clients to get off MAT? (discus dynamic of longer use and higher dosages as counterintuitive in SUD treatment) 8. Can MAT be effective and safe for pregnant women? 9. Is MAT effective for smoking? 10. What s on the horizon in terms of MAT. 11. A few years ago there were some major changes to the DSM definition of addiction can you speak to what those changes were and what are the implications? Can you explain how we are now defining addiction and how it s different? (DSM IV DSM 5 distinction in terms of casting a wider net to proactively treat at risk behaviors)

11 Diagnosis of Addiction DSM-5 released May 2013 Substance Use Disorder terminology 11 diagnostic criteria over a 12-month period: Mild: 2-3 symptoms Moderate: 4-5 symptoms Severe: 6 or more symptoms

12 - Excessive amounts used - Excessive time spent using/obtaining - Craving or urges to use - Unsuccessful attempts to cut down - Tolerance - Withdrawal - Hazardous use despite - Health problems - Missed obligations - Interference with activities - Personal problems

13 MAT for SUDs FDA has approved medications for: - Alcohol: Antabuse, naltrexone, acamprosate - Nicotine: NRT, Wellbutrin, Varenicline - Opioids: methadone, buprenorphine, xr-naltrexone Mechanisms: Aversion, anti-craving, substitution

14 Alcohol Neuropathology Decrease glutamate Increase GABA Increase Dopamine

15 OUD Neurochemistry Opioids activate opioid receptors in the brain Without opioids, unstable receptors lead to: Withdrawal symptoms Intense cravings Receptors are stabilized with MAT medications Patients on MAT: Experience fewer and less intense cravings Use drugs at much lower rates 1 4

16 Background: MAT for OUDs Opioids include synthetic pills, heroin, opiates Opiates are naturally occurring like opium or morphine Unlike other addictive drugs, opioids carry greater risks, such as overdose death Injection drug use adds risks such as infectious disease (HIV, Hepatitis C) and injuries 1 5

17 Background: MAT for OUDs MAT is the gold standard for OUD treatment, especially agonist therapy with buprenorphine or methadone: Reduces drug use Protects against overdoses Prevents injection behaviors Reduces criminal behavior 1 6

18 Background: MAT for OUDs MAT includes 3 modalities: Methadone (schedule II) Buprenorphine (schedule III) Naltrexone (not controlled) Each modality should be provided in addition to intensive psychosocial and behavioral therapy Patients benefit from MAT for >1-2 years of sobriety before attempting to taper, with dosing reassessments every 6 months 1 7

19 Background: MAT for OUDs Each MAT modality requires a different induction process for stabilizing the patient Each modality has different logistical and financial requirements Each modality has different pros and cons Patients may respond better to one modality As a result, all three should be available to every patient There is no evidence to limit length of treatment Longer Retention = Better Outcomes 1 8

20 Methadone (approved 1972) Invented in 1960s; President Nixon heavily funded methadone to treat Vietnam War veterans Highly regulated and provided through licensed programs that initially require daily attendance Methadone fully activates the opioid receptor but lasts for 24 hours, smoothing out highs and lows Methadone maintains opioid tolerance, lowering relapse and overdose rates if patients use opioids Higher doses (80-120mg) improve these outcomes 1 9

21 Methadone: Pros and Cons Pros Easy induction from active use Lower medication costs but program fees vary Best medication for retaining patients in treatment at 12 months (~80%) Lowers drug use and criminal activity Treatment of choice for pregnant women Friedman et al 1994; Lund et al

22 Methadone: Pros and Cons Cons Requires early morning daily dosing Many states and rural areas have limited access Programs can be targeted by drug dealers Patients often combine benzodiazepines and other medications to get high on a regular dose Can cause medical complications (arrhythmias) Patients face more stigma 2 1

23 Methadone: Monitoring Programs are heavily regulated at federal level Often have additional state-level restrictions Patients are directly observed taking doses Patients are frequently drug tested in the program Patients are only allowed take home doses once stable in recovery with negative urines Often program physicians refuse to prescribe benzodiazepines but patients find them anyway 2 2

24 Buprenorphine (approved 2002) Used since 1970s for pain Developed for addiction treatment more recently DATA 2000 Act allows individual physicians to prescribe via an outpatient office Physicians must complete 8-hour training (NPs 24 hours) and get waivered with a DEA X number to prescribe Can be prescribed with multiple refills Often sold as a combo product with naloxone [Suboxone] to deter abuse (i.e. injection) 2 3

25 Buprenorphine: Pros and Cons Pros Greatly reduces overdose risk Very good pain control with split dosing Can be prescribed like any other medication Often in prescription drug monitoring pgms (PMPs) Good for pregnancy, better newborn outcomes? Somewhat less stigma (remains controversial) 2 4

26 Buprenorphine: Pros and Cons Buprenorphine may produce better outcomes than methadone for pregnant women and newborns:

27 Buprenorphine: Pros and Cons Cons Patients must be in withdrawal to take first dose Can precipitate withdrawal if taken too soon As a result, some patients struggle to start Physicians need DEA waiver, few prescribe it Has street value and can be sold/diverted Patients can intentionally space out doses and use opioids in between Some people inject it (despite abuse deterrence) 2 6

28 Buprenorphine: Monitoring Check prescription drug monitoring program (PMP)! Requires routine urine testing Urine positive for bup (if negative, suggests diversion) Urine should be negative for opioids and benzodiazepines Aberrant behaviors must be monitored including: Losing prescriptions and/or running out early May need dose increase Prescribe for shorter intervals (i.e. weekly) Requesting dose > 16-24mg (suggests diversion) Use in-office medication counts

29 Naltrexone (approved 1984, 2010) Naltrexone binds tightly to opioid receptors, pushing off all other opioids (whether used before or after) Available as a daily pill or as a monthly injection, the blocker shot, called xrnaltrexone (Vivitrol) Completely protects from overdose for 4 weeks Reduces cravings due to activity at opioid receptor Does not cause physical dependence and patients lose their opioid tolerance while taking

30 Efficacy of Naltrexone: oral vs. XR injection Retention in treatment is used as a primary outcome of treatment with NTX as a great majority of patients on XRNTX remain abstinent Treatment retention rate in groups treated with XR preparations is twice that of the oral group, approximating 50-70% at 6 months

31 XR-Naltrexone Monthly injection, Vivitrol, is an extended release form of naltrexone enhancing outcomes Krupitsky, et al. 2011

32 XR-Naltrexone: Pros and Cons Pros Patients no longer fear going into withdrawal Blocks opioid use of any kind ~50% of patients test the blockade initially and quickly extinguish use Can be given as monthly injection (Vivitrol) to ensure adherence and block relapse Injection has 2x retention as oral treatment Less stigma 3 1

33 XR-Naltrexone: Pros and Cons Cons Most difficult induction, requires 3-10 days of abstinence: Patients must fully detox to start, often drop out Hard to find providers Some insurers don t reimburse (costs $1,500/mo) Lowers tolerance: if patients stop medication they could overdose if/when relapsing No pain relief and should be stopped for surgery 3 2

34 XR-Naltrexone: Monitoring Least likelihood of abuse/diversion (no street value) Injection is directly administered by clinician Frequent urine testing remains vital to treatment About half of patients test blockade initially; can be therapeutic experience, extinguishing behavior Patients with protracted withdrawal may require additional treatment Insomnia common for 1-2 months Anxiety and gastrointestinal distress also common 3 3

35 XRNTX: Patient Contraindications Anyone receiving long-term opioid therapy: maintenance, pain regimen, illicit use, etc. Allergies incl. sensitivity to components of the diluent Active liver disease, major renal impairment Coagulopathy/bleeding disorder If patient BMI precludes IM injection with the 2-inch needle provided (i.e. >30-35) Consider splitting into two 2cc deltoid injections

36 XRNTX: The First month after Often protracted withdrawal affects insomnia and anxiety Treat aggressively with comfort medication Schedule frequent follow up visits Monitor for patients testing the blockade Also monitor for new and unprecedented drug use or activity

37 XRNTX: Resources Providers Clinical Support System (PCSS) PCSS-MAT: PCSS-O: SAMHSA Brief Guide: Clinical Use of Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorder

38 DURATION OF TREATMENT

39 Bentzley 2015 (review bup Discontinuation) Study (N) Heroin Duration (taper) Sigmon 2013 (70) 50% 2 wks (1 v. 2) Avg Dose Treatment Abstinent F/u Post taper Abstinence 11.5mg 82% 9 wks 17% (21%) Weiss 2011 (323) 26% 12 wks (4) 20.8g 54% 8 wks 10% Ling 2009 (516) Woody 2008 (55) 83% 4 wks (1 v. 4) 76% 8 wks (4) 20.3mg 37% 4 wks 18% (18%) 15.1mg 54% 24 wks 34%

40 Sees 2000: MMTP v 180 day detox

41 Fiellin 2014: Bup taper v maintenance

42 Warden et al: 2012 (youth)

43 TAPERING

44 Tapering Typically patients with continuous sobriety for 1-2+ years have the best outcomes Treatment <6 months has worse outcomes There is no evidence to support stopping MAT 95% of methadone patients do not achieve abstinence when attempting to taper off (Nosyk, et al. 2013) Over 90% of buprenorphine patients relapse within 8 weeks of taper completion (Weiss, et al. 2011) Successful patients are commonly maintained on Methadone for 24+ months, Buprenorphine for 18+ months 4 3

45 Tapering Clinical considerations before tapering: Treatment history (i.e. prior relapse after taper) Addiction history (length/severity) Family history Resilience and personality traits Life stressors, loss, and transitions Patient motivations for tapering Alford et al., 2011; Stimmel et al.,

46 Tapering Methadone and buprenorphine Better results with longer taper (over months) Methadone programs often blind the dose May need new medications for symptom relief Many patients relapse during this process Should only be attempted when clinically indicated (not for insurance or regulation) Should not occur during major stressors XR-Naltrexone does NOT require tapering Patients become unblocked after 4 weeks 4 5

47 Tapering Overall: longer, slower tapers work better Tapering some patients from buprenorphine may be more difficult and may require a longer period of time than tapering from methadone Consider following a taper with xr-naltrexone for a year or longer (Weiss et al., 2011) 4 6

48 Long-term Recovery Can you be in recovery while on medications?

49 Long-term Recovery Can you be in recovery while on medications? YES!

50 Long-term Recovery Can you be in recovery while on medications? YES! ASAM, AAAP, NIDA, SAMHSA, FDA, CDC, AMA, ONDCP

51 RECOVERY SAMHSA: A process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential.

52 RECOVERY ASAM: In most cases of addiction, the integration of psychosocial rehabilitation and ongoing care with evidence-based pharmacological therapy provides the best results. Chronic disease management is important for minimization of episodes of relapse and their impact.

53 RECOVERY NIDA: Recovery from drug addiction is a long-term process and frequently requires multiple episodes of treatment. As with other chronic illnesses, relapse to drug abuse can occur and should signal a need for treatment to be reinstated or adjusted. Because individuals often leave treatment prematurely, programs should include strategies to engage and keep patients in treatment.

54

55 References Alford, D., LaBelle, C., Kretsch, N., Bergeron, A., Winter, M., Botticelli, M., & Samet, J.H. (2011). Collaborative care of opioid-addicted patients in primary care using buprenorphine: Five-year experience. Archives of Internal Medicine, 171(5), Friedmann P, et al (1994). Retention of patients who entered methadone maintenance via an interim methadone clinic. J Psychoactive Drugs. Apr-Jun; 26(2): Fullerton C, Kim M, Thomas CP (2014). Medication-assisted treatment with methadone assessing the evidence. Psych Services. 65(2) Krupitsky, et al. (2012). Randomized Trial of Long-Acting Sustained-Release Naltrexone Implant vs Oral Naltrexone or Placebo for Preventing Relapse to Opioid Dependence. Archives General Psychiatry. Sep; 69(9):

56 References Lund IO et al. (2013). A comparison of buprenorphine + naloxone to buprenorphine and methadone in the treatment of opioid dependence during pregnancy: maternal and neonatal outcomes. Subst Abuse 7:61 74, Nosyk B, Anglin D, Brissette S, et al (2013). A call for evidence-based medical treatment of opioid dependence in the United States and Canada. Health Affairs; 32(8) Stimmel, B., et al. (1977). "Ability to remain abstinent after methadone detoxification: a six year study." Journal of the American Medical Association 237(12): Weiss RD, Potter JS, Fiellin D, et al. A Two-Phase Randomized Controlled Trial of Adjunctive Counseling during Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence. Arch Gen Psychiatry. 2011;68(12):

57 Resources The American Academy of Addiction Psychiatry (AAAP) Provider s Clinical Support System: The National Council for Behavioral Health Resource site for MAT: MAT Medication-Assisted Treatment: Lessons Learned from the Field Webinar: Powerpoint: file:///c:/users/nicks/downloads/master%20presentation%20final.pdf

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