Medication Assisted Treatment for SUD: Extended Release Naltrexone Improves Treatment Outcome

1. Medication Assisted Treatment for SUD: Extended Release Naltrexone Improves Treatment Outcome Desirée A. Crèvecoeur-MacPhail, PhD UCLA Integrated Substance Abuse Program Los Angeles CA California SUD/Health Care Integration Learning Collaborative (ILC) September 24, 2014

2. Disclosures • No part of this research was funded by Alkermes who manufactures XR-NTX • This project was funded solely by the Los Angeles County Department of Public Health Substance Abuse Prevention and Control

3. What is Medically Assisted Treatment (MAT)? • 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 • Research shows that when treating substance use disorders, a combination of medication and behavioral therapies is most successful

4. Antagonist Medications • Decrease pleasure and reward • Have similar structure and bind to same receptor sites as drug of abuse • Provide no activation • Block full and partial agonists from binding at receptor sites • May induce withdrawal symptoms • Example: Naltrexone

5. Naltrexone/XR-NTX for Opioid and Alcohol Dependence • Full MU opioid receptor ANTAGONIST No opioid effect

6. XR-NTX (Vivitrol) • Monthly intramuscular injection • Given by nurse, PA, MD, other • Non-narcotic, prescribed by MD/DO/NP • Not for use if: • Pregnancy • Severe liver disease • Chronic pain requiring opioids

7. The LA County Project: Evaluation Background

8. Evaluation Questions • Will patients take multiple doses? • How did the Urge to Drink/Use score change? • Compared to the Post-hoc group, what proportion of the XR-NTX group: • Engaged in treatment (LOS 30+ days)? • Retained in treatment (LOS 90+ days)?

9. Evaluation Design: Scales & Tools • 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

10. Evaluation Design • The three medication hubs: • Tarzana Treatment Center (main hub) • Behavioral Health Services • Prototypes • Selection criteria: • Infrastructure (staff, examination room, refrigerated and locked location for medication storage) to administer medications • Long-standing histories of providing quality substance abuse treatment to a broad range of clients

11. Evaluation Design: Procedures • Three medication hubs were selected based on existing infrastructure. • Counselors attended a training. • Patients were offered the opportunity to utilize XR-NTX once per month. • Data were collected on participants’ urge to use, medication side effects and days of use. • Data was collected at weeks 0, 1, 2, 3 post injection and then monthly thereafter.

12. Evaluation Design • No random assignment • The three medication hubs • Clients went to hubs for medication and returned to their treatment agency for psychosocial treatment • Hub selection criteria: • Infrastructure to administer medications • Long-standing histories of providing quality substance abuse treatment

13. Overall Results

14. XR-NTX Doses in LA County Among LAC XR-NTX Patients(N=609) Bottom line: Patients received two to three doses of XR-NTX, regardless of substance use disorder.

15. Clinical Characteristics Comparison of LAC XR-NTX Patients(N=609) Bottom line: XR-NTX recipients appear to have a more substantive SUD history as compared to the typical patient in LA County.

16. Patient Demographics by Gender Among UCLA XR-NTX Participants (N=465) *p<.05; **p<.01 aOther race/ethnicity includes multi-racial, Native American & Asian

17. Reduced Urge to Drink/Use Among UCLA Phase 2 XR-NTX Participants (N=220) Based on the Urge to Drink/Use Scale, which is scored from 0 to 30. A score of 10 or more indicates danger of relapse.

18. Reduced Urge to Drink/Use by Gender Among UCLA Phase 2 XR-NTX Participants (N=220) Based on the Urge to Drink/Use Scale, which is scored from 0 to 30. A score of 10 or more indicates danger of relapse.

19. Limited Side Effects Among UCLA Phase 2 Participants (N=220)

20. Clinical Characteristics by Gender Among UCLA Phase 2 XR-NTX Evaluation Participants (N=220) • *p<.05; **p<.01

21. Comparison Results Results Significant at p<.05 or better

22. Two Groups • XR-NTX (n = 190) • Received at least one dose of medication • No random assignment – wanted medication, got medication • Post-hoc Comparison (TAU) (n = 190) • Did not receive medication • Demographics matched to XR-NTX group • Calculated propensity scores

23. Participant Characteristics • *Lifetime report of mental illness differed between groups; p<.01

24. Participant Characteristics *Days spent on the wait list significantly differed between the groups p<.001.

25. Engagement & Completion Rates for XR-NTX and Post Hoc (TAU) Clients Engagement and Completion Rates of XR-NTX Treatment Clients vs. TAU Treatment Clients

26. XR-NTX & Engagement • Engagement = In treatment for 30+ days • Predictors included • XR-NTX (p < .001) • OR (95% CI) = 12.609 (5.178-30.706) • Age at first use (p < .05) • OR (95% CI) = 1.066 (1.009-1.126)

27. XR-NTX & Retention • Retention = In treatment for 90+ days • Predictors included • XR-NTX (p < .001) • OR (95% CI) = 3.868 (2.352 – 6.361) • Race (African American vs. White) (p < .05) • OR (95% CI) = .380 (.175 - .826) • Mental illness diagnosis (p <.01) • OR (95% CI) = 2.415 (1.370 – 4.258)

28. Additional Findings

29. Examine Access to Prevent Disparity • Treatment providers may have promoted XR-NTX to the patients with more severe SUD histories • Men and some racial/ethnic minorities may be underrepresented among XR-NTX recipients • Further research is warranted to examine if geographic area or organizational characteristics predicts access to XR-NTX Bottom Line: Not only is it important to provide evidence based practices, like MAT, but it is also important to ensure equal access for all patients.

30. Addressing Barriers • 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

31. Summary of Findings on Gender • No differences in the total number of doses (not shown) by gender • Women may have a greater need for SUD treatment that addresses co-occurring MH and parenting needs • Women may need support in managing side effects • Qualitative findings (not shown) suggest similar experiences with XR-NTX

32. What about: Treatment Integration?

33. Expansion of Availability of MAT • Number of SUD treatment programs with patients taking XR-NTX before LA County Study: 1 program • Number of SUD treatment programs with patients taking XR-NTX after LA County Study: 32 programs

34. Expansion to Other Areas of CA? • Many other counties and jurisdictions in CA using the medication: • Orange County: starts in jail, also used by probation • Santa Cruz County: similar to OC program • San Mateo County: DD clients with AUD • Sacramento: small, but very successful – no crime, tx compliant, clean urines • San Francisco: VA using with Homeless Veteran project

35. Use of Medication Requires Collaboration • In all counties, some collaboration needed between (some or all of) offices below • Substance Use Treatment • Primary Healthcare • Sheriff’s Department • Probation Department • Behavior Health • Funding varied – Medi-Cal (not Drug), AB109, Gov grants

36. Conclusions • Although no causal conclusions can be made, XR-NTX was associated with increases in • Treatment engagement • Treatment retention • Positive compliance in treatment • Reductions in use were noted

37. 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 first pilot, doses are capped at 3; but client may acquire additional doses if • Request made to Medical Director at SAPC • Urges remain high • Client remains in treatment

38. 45-year-old, Latina female who has been trying to stop drinking for 15 years. She has been in “over 20 detoxes” and this is her fifth time in residential treatment. This is the first time, thanks to XR-NTX, that she has lost the craving for alcohol since she began drinking as an adolescent.

39. 52-year-old, Caucasian male who has been drinking since 14 years of age. He tried to stop drinking for 25 years on his own or through 12-step programs. He never achieved more than 3-4 months of sobriety at a time. This is his 2ndTx program; in his first program he lasted two months – “thinking about drinking every single day. I couldn’t get it out of my head, so I left.” Currently, he has received 2 XR-NTX injections and has “been able to concentrate on the counseling work” since the third day after his first injection. He was on a pass last week and passed the liquor store where he has been “keeping a tab” for 15 years and “didn’t even realize I went by it until I was three blocks away. XR-NTX is fantastic!”

40. 36-year-old, American Indian male with a 20-year history of alcohol and methamphetamine abuse and a co occurring diagnosis of bipolar disorder.He has been in treatment 4 times since he began trying to stop using 8 years ago. While he did manage to stop using meth 4 years ago, his daily drinking has been steadily getting worse over the last two years, most often leading to blackouts. He has received 4 XR-NTX injections so far and says he has not had any urges to drink since “a couple of days after the first shot.”

41. Acknowledgements • Sarah J. Cousins, MPH • Kira Jeter, MA • Diane Herbeck, MA • Eva Vasquez • Reham Abdel Maksoud, MBBS • Stefanie Weimann, MA • Dave Bennett, BA • Mary-Lynn Brecht, PhD • Richard A. Rawson, PhD • Loretta L. Denering, MS

42. Thank You! Desiree A. Crevecoeur-MacPhail, Ph.D. (310) 267-5207 email: desireec@ucla.edu