Medical Assisted Treatment of Opioid

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2 Medical Assisted Treatment of Opioid Dependence with XR-NTX(Vivitrol) Michael McNamara DO, FACN Medical Director Mental Health Center of Greater Manchester Manchester NH

3 Outline Overview of Opioid Dependence Guideline for MAT in NH by NH Dept of Health & Human Services Neuro Biology of Drug Addiction MAT Drugs Approved by FDA for Opioid Dep- Comparisons History of Naltrexone Use in USA Drug Properties of XR-NTX(Vivitrol) XR-NTX(Vivirol) studies for Opioid Dependence Patient Selection and Princilpes of XR-NTX Induction Need for UA Monitoring and Clinical Consderations Monitoring Patients Progress in Recovery Conclusion

4 Opioid dependence is a major public health concern Rates of opioid dependence throughout the world/us have been on the increase increased morbidity and mortality poor social functioning unemployment, and crime associated with this disorder Opioid dependence is a chronic disorder requiring long-term treatment Addiction, 108, , 2013

5 Opioid dependence low rates of treatment-seeking*** poor adherence to treatment frequent relapse major societal consequences Krupitsky et al 2011 ***- deaths, more difficult withdrawal from Fentanyl

6 Overdose Opioid Deaths explode in ,000 Rx deaths 20,000 heroin overdose deaths Still increasing in 2016 thru 2017 For Perspective Peak gun deaths= 39,000 in 1993 Peak HIV deaths= 47,000 in 1995 Peak car deaths=54,000 in 1972 US War casualties in Viet Nam 58,220 RA Rudd et al 2016, mod after Liga OMED 2017 Philadephia PA

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8 2012, Principles of Addiction Treatment, NIDA

9 Released by NH DHHS- January 2016

10 Guideline for MAT in NH by NH Dept of Health & Human Services Released by NH DHHS- January 2016

11 Guideline for MAT in NH by NH Dept of Health & Human Services Released by NH DHHS- January 2016

12 The Development and Maintenance of Drug Addiction Neuropsychopharmacology (2014) 39, ; doi: /npp

13 MAT- Medication Assisted treatment Drugs FDA approved for Opioid Dependence- 1 Methadone- pure agonist 2 Buprenorphine mixed agonist /partial blocker 3 Naltrexone (oral) & Vivitrol (IM)- Blocker Difference between Subxone and Subutex Suboxone contains : Buprenorphine and Naloxone Subutex contains: Buprenorphine

14 Pros and Cons of MAT with XR-NTX Pros Not a narcotic No problem with illicit diversion If patient wishes to stop no withdrawal symptoms Prescribers can include NP/DO/MD/PA s no special license needed-non controlled drug Cons Very expensive if no insurance coverage Still hard to find treatment providers in some areas Patient needs to be free of Opioid use 7-10 days

15 Extended-release Naltrexone for Alcohol and Opioid Dependence: A Meta-Analysis of Healthcare Utilization Studies 2014 Hartung et al- Conclusion :XR-NTX $8170 lower costs Per PT/ 6 mos

16 History of Naltrexone- Opioid Antagonist Approved by FDA for ETOH Dependence 1984 (Brand Name ReVia) Approved by FDA for Opioid Dependence 1994(Brand Name ReVia) Approved by FDA for ETOH Depenence 2006 as extended Release form lasting 28 days per IM dose XR-NTX(Brand Name Vivitol) Approved by FDA for Opioid Dependence 2010 as extended Release form lasting 28 days per IM dose XR-NTX(Brand Name Vivitrol) 1971 Naloxone approved for rapid reversal of Opioid Overdose- short acting Opioid Antagonist

17 6-Beta-naltrexol is Major Metabolite Study Week 2006, Comer et al

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19 Concerns about compliance with oral naltrexone led to the development of a once-monthly extended-release formulation of injectable naltrexone (XR-NTX; Vivitrol ; Alkermes, Inc.,Waltham, MA, USA). In this formulation, naltrexone is gradually released from microspheres composed of poly- (d,l-lactide-co-glycolide), a polymer used in dissolvable surgical sutures

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21 XR-NTX- Vivitrol Studies Krupitsky et al- 24 week RTC study punlished in Lancet Krupitsky et al- 1 year open label extension study- published in Addiction 2016 Lee et al- 24 week US study to prevent Opioid relapse in Criminal Justice Offenders published in NEJM All studies favor XR-NTX

22 2011 Lancet Study- XR-NTX(Vivitrol) Double Bind, Placebo controlled, RTC 24 week trial of Opioid Dependence Patients Pts 18 years or older with 7 days or more off Opioids- most thru Detox 13 Clinical sites in Russia Pts assigned 1:1 either placebo or 380 mg XR-NTX Primary endpoint was abstinence assessed thru UA s Secondary endpoint included Craving scores-

23 Exclusion Criteria LFTs (ALT, AST) greater than 5 times upper limit of normal Presence of pain of sufficient severity as to require ongoing pain management with opioids if female, currently pregnant or breastfeeding, or planning on conception

24 Demographics and Baseline Characteristics

25 Results Krupitsky el al Vivitrol Study XR-NTX(Vivitrol)- superior to Placebo with confirmed Abstinence Craving decreased in XR-NTX treatment group Antagonist welcome addition as an option for MAT of Opioid Dependence

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27 Who Responds to Vivitrol- XR-NTX XR-NTX Placebo Krupitsky et al Lower Serverity Higher Severity

28 Change in Percent Of Patients Abstinent All Patients * *** ** Patients with Opioid Problems 10 0 *** ** XR-NTX Oral NTX BUP No Meds *p<0.05, **p<0.01, ***p<0.001, vs XR-NTX 2015, P. Crits-Christph et al

29 Craving Craving is an important diagnosis criterion for SUD- DSM-V Can be predictive factor of relapse Social and environmental clues can trigger craving and provoke relapse Relationship between Stress and Craving XR-NTX can have an impact and lower Craving

30 week RTC Study- Craving Krupitsky et al 2011

31 Functional magnetic resonance imaging (fmri) in conjunction with a validated cue-induced craving procedure to examine neural correlates of XR-NTX and Craving 2015, Obrien et al

32 Referrals- MHCGM Vivitrol clinic Opened June 2016 Word of mouth Hospitals /Rehab programs/serenity House- Manchester PO s & drug court Clinic consists of LADC, DO prescriber, & nurse who acts as coordinator Pt attends weekly groups at MHCGM and in community and other recovery work

33 Patient Selection and Naltrexone Induction Does pt have Opioid Dependence- take History past Treatment No Use of Opioids past 7-10 days* Does pt have history or current co-morbid SUD s Assess Motivation and willingness to engage in Recovery work Pt willing to submit to UDT and Sign Treatment Agreement Pt s health- are they candidates for Vivitrol- females not pregnant Does patient have past/present Mental Health issues- Stable? Pt willing to be placed on Vivitrol after explaining to them risks and possible side effects? Pt willing to have Naltrexone Challenge test when asked? Pt willing to be tested on Oral Naltrexone First

34 Naltrexone challenge Test Positive if appearance of vital sign elevations or opioid withdrawal symptoms after pt has been given mg of Oral Naltrexone with 1-2 hours Performed on most patients for first injection and for pt suspected of use prior to subsequent Vivitrol monthly injections

35 Nurse Checklist Vivitrol Clinic Nurse Coordinates patient care at MHCGM Vivitrol Clinic 1. When patients present for 1 st appointment obtains UA-tracks UA results 2. When pt presents for Vivitrol injections asked pt about recent use-calls prescriber if pt needs Naltrexone Challenge test and calls with results 3. Ask pt about injection site/medication SE s 4. Has patient provide updated meds list from other providers 5. Pt expected to submit UA at each Injection appointment and may be called in for Random UA s 6. Asked pt to provide/update attendance sheets for recovery work/groups 7. Coordinates appointments with prescriber and LADC and outside patient treatment contacts 8. Helps patient looking into best insurance for coverage of Vivitrol(Medicaid) 9. Assists with Vivitrol PA approval process 10. Notifies prescriber and LADC of missed appointment /request for UA s

36 Protracted Withdrawal- Natrexone Flu A possibility when starting XR-NTX right after detox Flu like symptoms: Insomnia, GI upset,ha s,anergy,hyperalgesia Anxiety, irritability, dysphoria, anhedonia Can decrease risk by waiting post detox-but risk relapse Symptoms Remit in 2-4 weeks Bisaga PCSS-MAT Training

37 URINE DRUG TESTING Medication Assisted Treatment Guidance Document - January 2016 NH DHHS

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41 Clinical considerations Pregnancy Elevated Liver enzymes Relapse management Need for pain management Transition from Methadone/Suboxone to XR-NTX?? When to discontinue use of XR-NTX

42 Monitoring Patients Progress in Recovery How are goals progressing- Work, increasing support system, creating stable living arrangement, getting help for Mental Health Conditions, Education of Opioid Dependency Engaging in recovery work and recovery support system Warnings for non-adherence and consequences per treatment Agreement

43 Fini Questions/Comments/Feedback