John Viernes, Jr. Executive Director. Substance Abuse Prevention and Control (SAPC) Los Angeles County Department of Public Health

Transcription

1 Extended-Release Injectable Naltrexone (Vivitrol) Pilot Project in Los Angeles County John Viernes, Jr. Executive Director Substance Abuse Prevention and Control (SAPC) Los Angeles County Department of Public Health

2 Disclosures This project was funded entirely by treatment funds allocated to Los Angeles County. None of the research pertaining to this project was funded by Alkermes who manufactures Vivitrol. 2

3 What is Vivitrol? Extended-release injectable naltrexone Approved for the treatment of alcohol dependence in Approved for the treatment of opiate dependence in An opioid receptor antagonist that blocks the mu-opioid receptors in the brain. Mu-opioid receptors are responsible for the high or buzz individuals feel when alcohol is consumed or opiates are used. When the receptors are blocked, the high or buzz experienced and the cravings for alcohol and the high experienced by opiates is eliminated.

4 Benefits of Vivitrol Treatment Reduces the number of risky and heavy drinking days. Augments cognitive behavioral therapy because naltrexone increases periods of abstinence and decreases rates of heavy drinking. Eases discomfort of withdrawal symptoms in early recovery. Improves individuals quality of life. Source: Garbutt et al., 2005; Lee et al., 2010; Manelli, 2007; Pettinati et al., 2009; Schmitz et al., 2001; Manelli et al., 2011

5 Precautions with Vivitrol Treatment Client must be abstinent from all opiates for at least 10 days. Ideally, client must be abstinent from alcohol for at least 7 days. Not approved for anyone under 18; or pregnant woman and woman who are nursing. Not approved for anyone with active hepatitis or elevated liver enzymes.

6 Vivitrol Pilot Project Phase I 6

7 Vivitrol Treatment Sites (Phase I)

8 Outcome Evaluation Questions Do clients remain on Vivitrol beyond the 1st dose? Does Vivitrol affect client outcomes (e.g., urge to drink, treatment engagement and completion)? As a result of trainings, do staff knowledge and attitudes toward medication-assisted treatment (MAT) improve at 4 month follow-up compared to baseline?

9 Data Collection Patient Response to Vivitrol Urge to Drink/Use Scale (UDS) Medically Assisted Treatment Survey (MATS) Counselors Attitudes Counselor Attitude Survey Treatment Outcomes Los Angeles County Participant Reporting System (LACPRS) data Site Visits Over 60 site visits conducted at 25 sites over 9 months. Provide training/education.

10 Results (Phase I)

11 Participant Characteristics Asian/Pacific Islander 1.3% African American 9.8% American Indian/Alaskan Native 0.8% Other 3.1% Female 49.6% Male 50.4% Hispanic/ Latino 32.0% White 53.0% Gender Ethnicity N=399 Mean Age=38 years (SD=10.3)

12 Vivitrol Doses by Sites One Dose Two Doses Three Doses Four or More Doses 45.5% 41.1% 36.7% 24.0% 22.6% 22.1% 21.0% 28.2% 30.9% 25.6% 30.0% 20.0% 12.3% 11.4% 15.4% 13.3% Total Tarzana Prototypes BHS (N=399) (N=290) (N=39) (N=70)

13 Urge to Drink Scores UDS Score Week 0 Week 2 Week 3 Week 4

14 Side Effects

15 Treatment Outcomes Percent Treatment Engagement Abstinence at Discharge Treatment Completion County Average Vivitrol Treatment Clients

16 Counselor Attitudes Baseline vs. 4 month later follow-up survey Counselor attitudes improved over the course of the project. Many who initially reported neutral or negative attitudes toward MAT in general, or Vivitrol in particular, reported positive attitudes on the follow-up survey.

17 Vivitrol Pilot Project Phase II 17

18 Phase II Cohorts (N=244) Non Follow-Up 12.7% Follow-Up 87.3% Drug Court 17.5% Non-Drug Court 82.5% Primary Drug Problem for Using Vivitrol Alcohol 72.5% Opioids 27.5% 18

19 Vivitrol Treatment Sites (Phase II) BHS 34.6% AVRC 25.2% Prototypes 12.2% Tarzana 27.0% (N=244)

20 Results (Phase II)

21 Vivitrol Doses (N=244) 36.5% 26.6% 21.7% 15.2% One Dose Two Doses Three Doses Four or More Doses

22 Urge to Drink Score among Vivitrol Patients with Alcohol Problems Urge to Drink Score Week 0 Week 1 Week 2 Week 3 Week 8 Week 12 FU 1 FU 2

23 Urge to Use Score among Vivitrol Patients with Opioid Problems Urge to Use Score Week 0 Week 1 Week 2 Week 3 Week 8 Week 12 FU 1 FU 2

24 Side Effects % Reporting Side Effects 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Site Reaction Nausea Fatigue Headache Other Side Effects Week 1 Week 2 Week 3 Week 8 Week 12 24

25 Days Used and Days Intoxicated in the Past Month 30 Days Used Days Use in the Past Month Days Intoxicated Week 0 (n=212) Week 8 (n = 84) Week 12 (n = 53) FU 1 (n = 143) FU 2 (n = 121) 25

26 Conclusions Although no causal conclusions can be made, Vivitrol was associated with: An increase in medication adherence A decrease in urges to drink alcohol or use opioids A decrease in other substance use An increase in treatment engagement and completion

27 Next Steps Policy changes needed to expand the availability of Vivitrol. Recommendations on how Vivitrol can be purchased at the most affordable price. Examine the efficacy of Vivitrol as cost effective measures to improve outcomes. Examine long-term effects of Vivitrol.

28 Questions?

29 Acknowledgements Desiree A. Crevecoeur-MacPhail, Ph.D. James H. Barger, M.D. Tina Kim, Ph.D. Shantel Muldrew, MPH Ricardo Contreras, MPH Ben Lee, Ph.D. Susan Lesser, MPH Christina Jackson, MPH