SUMMARY REPORT MEETING 37 Date: Time: Location: Hosts: Wednesday, September 24, 2014 11:00AM – 12:00PM Webinar/Conference Call UCLA Integrated Substance Abuse Programs (ISAP) & the California Department of Health Care Services (DHCS) Topic: Medication Assisted Treatment for SUD: Extended Release Naltrexone Improves Treatment Outcomes Desirée Crèvecoeur-MacPhail, PhD UCLA Integrated Substance Abuse Programs Presenter: Logistics Summaries and materials discussed from previous ILC meetings are available at http://www.uclaisap.org/integration/html/learningcollaborative/index.html. Subsequent meeting materials will continue to be posted on this site. Upcoming ILC meetings will be held on October 29, 2014 and November 19, 2014 from 11:00 AM to 12:00 PM. All further meetings are scheduled to be held at 11:00 AM (PT) on the 4th Wednesday of every month, unless otherwise noted. ILC Meeting 37 Topic: Medication Assisted Treatment for SUD: Extended Release Naltrexone Improves Treatment Outcomes Topic Introduction – Brandy Oeser, MPH, UCLA ISAP For today’s learning collaborative meeting, Dr. Crèvecoeur-MacPhail will discuss the implementation of extended-release injectable naltrexone (brand name Vivitrol®) into a county SUD treatment system and the effect on treatment outcomes for opioid and alcohol users. Though this was not a randomized study, use of naltrexone was associated with better engagement and retention rates. Future plans with the project and data will also be discussed. Desirée Crèvecoeur-MacPhail, PhD UCLA Integrated Substance Abuse Programs Summary Disclosure o This project was funded solely by the Los Angeles County Department of Public Health Substance Abuse Prevention and Control. No part of this research was funded by Alkermes, which manufactures XR-NTX. Introduction: What is MAT? o According to SAMHSA: “MAT is the use of medications, in combination with counseling and behavioral therapies, to provide a whole-patient approach to the treatment of substance use disorders.” o Combination of medication and behavioral therapies has been shown to be successful. Introduction: What is Vivitrol? o Antagonist medications Work by decreasing reward responses in the brain when exposed to alcohol and certain other drugs. Unlike agonists, they provide no activation in the brain receptors and may induce withdrawal symptoms if lingering opiates are remain in the individuals’ system when the antagonist medication (e.g., naltrexone) is taken. Therefore, patients must be abstinent from these drugs for a certain period prior to taking naltrexone. o Naltrexone Naltrexone is classified as full MU opioid receptor antagonist. Developed around the 1980s, originally in the pill form. The pill form works well for those who keep the prescribed daily schedule, but it is difficult for patients to take it regularly as prescribed. XR-NTX (the extended release version) has been approved by the FDA for alcohol dependence and opioid use relapse prevention. Injections are administered monthly, making adherence much easier for patients. o XR-NTX (Vivitrol®) The federal government put out an RFA asking drug companies to create a long-acting form of naltrexone and gave approval for Alkermes to produce to drug using their formulation. Characteristics and use: Vivitrol is given via a monthly intramuscular injection Non-narcotic, prescribed by MD/DO/NP Injected by nurse, PA, MD or other qualified medical professional Typically no interactions with HIV medications, hepatitis C medications, or psychotropic medications (e.g., for depression, bipolar disorder, schizophrenia) DOES have interactions with opioid-based medications Not for use in cases of: pregnancy; severe liver disease; chronic pain requiring opioids Approved for adults only LA County Project: Evaluation Background and Design o Project Background An initial pilot program was implemented in LA County prior to the current project under discussion; UCLA was later asked to put together a study of the implementation of the medication. o Evaluation Questions The UCLA evaluation questions were: Will patients take multiple doses? How did the Urge to Drink/Use score change? Treatment outcomes – compared to the Post-hoc group, what proportion of the XR-NTX group: o Engaged in treatment (length of stay 30+ days)? o Retained in treatment (length of stay 90+ days)?, particularly in outpatient counseling programs o Measures Treatment Outcome Data Los Angeles County Participant Reporting System (LACPRS) Patient Response to XR-NTX Medically Assisted Treatment Survey (MATS) Urge to Drink Scale (UDS) Counselor attitudes o LA County Background In LA County, SAPC contracts with treatment providers to provide treatment. About ~200 agencies contracted in LA County and represented 300-350 sites (400-500 specific programs). Staffing available at each of these sites varies, so instead of requiring that all sites had available medical staff to administer the medication, the project was set up so that there were three medication hubs which administered the medication (discussed below). o Medication Hubs Three medication hubs (7-8 different sites around county): Tarzana Treatment Center (main hub) Behavioral Health Services Prototypes Hubs were selected because they had the available infrastructure (staff, examination room, refrigerated and locked location for medication storage) necessary for successful implementation of XRNTX and had a long-standing history of providing quality SUD treatment to a broad range of clients. The medication hubs distributed the medications, and treatment providers were allowed to refer their clients to the hubs. At the hubs, patients received medical tests, and if approved for the medication, were administered the XR-NTX. Then the patients returned back to their original treatment programs to continue with their psychosocial counseling. LA County provided funding via a supplement to their contracts with the medication hubs. The county paid for the medications and provided an additional stipend to cover the cost of medical screenings and other services related to XR-NTX administration. LA County Project: Evaluation Procedures o Three medication hubs were selected based on existing infrastructure (described above). o Counselors at participating sites attended a training organized by SAPC. Trainings around county were also held for any programs interested in having one or more of their clients on the medication. o Eligible patients were offered the opportunity to utilize XR-NTX once per month. (Because this was an implementation study, there was no random assignment). o Data were collected on participants’ urge to use, medication side effects and days of use. o Data was collected at weeks 0, 1, 2, 3 post injection and then monthly thereafter. Overall Results o Conclusions On average, patients received about 2-3 doses of XR-NTX, regardless of substance (alcohol or opioid), a positive sign indicating that patients do not have a problem taking multiple doses of injectable naltrexone. The pill form of the drug has been shown to have very low refill rates as people do not continue to take the drug in that form. XR-NTX recipients appear to have a more substantive SUD history as compared to the typical patient in LA County. Though no causal conclusions can be made, XR-NTX was associated with positive outcomes: Improved treatment engagement Improved treatment retention Positive compliance in treatment Reductions in use o Additional Findings and Lessons Learned Funding varies and included Medi-Cal, AB 109, government grants (used to set up processes around using the medication, but not to pay for the medication itself) Use of the medication required collaboration between some or all of the following: SU treatment Primary healthcare Sheriff’s Department Probation Department BH department Addressing barriers involved the following: LA County increased availability of XR-NTX as a treatment option Obtained a grant for drug court patients Medication hubs linked with referring agencies to provide medical screenings and provide XR-NTX doses Transportation to/from Tx and the medication hub was coordinated Education sessions to increase knowledge of MAT among Tx providers Before the LA County study, 1 SUD treatment program had patients taking XR-NTX; after the study, the number of programs with patients taking XR-NTX expanded to 32 o Policy Changes Substantial work done to reduce time required to get approval from Medi-Cal – down from almost 3 months to 3-5 days Given results from the first pilot, doses are capped at 3, but clients may acquire additional doses (up to 6) if: Request made to Medical Director at SAPC Urges remain high Client remains in treatment o Expansion to Other Areas of CA Many other counties and jurisdictions in California have started using the medication, including: Orange County, Santa Cruz County, San Mateo County, Sacramento County, San Francisco County APPENDIX – Relevant Materials MATERIALS FOR THIS MEETING PPT Presentation – Medication Assisted Treatment for SUD: Extended Release Naltrexone Improves Treatment Outcomes RELEVANT LINKS SAMHSA-HRSA Center for Integrated Health Solutions: Overview of Medication Assisted Treatment (MAT) http://www.integration.samhsa.gov/clinical-practice/mat/matoverview SAMHSA Advisory: An Introduction to Extended-Release Injectable Naltrexone for the Treatment of People with Opioid Dependence http://store.samhsa.gov/product/An-Introduction-to-ExtendedRelease-Injectable-Naltrexone-for-the-Treatment-of-Peoplewith-Opioid-Dependence/SMA12-4682 Copies of materials can be found at UCLA ISAP’s Integration Website: http://www.uclaisap.org/integration/html/learning-collaborative/index.html.