Implementation of Antagonist Medication into SUD Treatment System

1. Implementation of Antagonist Medication into SUD Treatment System Desirée A. Crèvecoeur-MacPhail, PhD Sarah J. Cousins, MPH Kira Jeter, MPH UCLA Integrated Substance Abuse Program Los Angeles CA Department of Health Care Services Substance Use Disorders Statewide Conference Costa Mesa, CA August 2014

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

3. Learning Objectives • Define medically assisted treatment • Identify at least one benefit of using medically assisted treatments, such as XR-NTX, among alcohol or opioid users • Identify disparities in access to XR-NTX • Describe at least one association between gender and subsequent doses of XR-NTX for alcohol use disorders

4. Learning Objective #1 Define medically assisted treatment

5. 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

6. Partial/Full Agonist, Antagonist, What’s the Difference?

7. Agonist Medications • Similar structure and bind to same receptor sites as drug of abuse • Full activation at receptor site • Synthetic opioid that binds to receptors activated by heroin and other opioids • If taken as prescribed, user does not experience euphoria or intoxication • Example: Methadone

8. Partial Agonist Medications • Similar structure and bind to same receptor sites as drug of abuse • Provide partial activation at site • Relief from craving & withdrawal • Degree of activation less than full agonist • Block full agonists from binding • Limit drug’s effect if substance is subsequently used • Example: Buprenorphine

9. 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

10. No opioid effect Full MU Agonist: Methadone Partial MU Agonist: Buprenorphine Full MU Antagonist: Naltrexone • Naltrexone has the highest receptor BINDING AFFINITY, then buprenorphine, then methadone

11. Agonist/Antagonist Medications • Best of all worlds? • Provides some relief from withdrawal but also binds with the site so that patients cannot abuse the agonist Suboxone= Buprenorphine + Naloxone is an agonist/antagonist combo • Naloxone is a powerful opioid receptor antagonist that will displace other opioids and precipitate withdrawal

12. What is XR-NTX (Vivitrol)? • Injectable extended release naltrexone (XR-NTX) was FDA approved in 2006, for the treatment of alcoholism • In 2010, the FDA approved Vivitrol for the opioid use relapse prevention • An antagonist - blocks the mu-opioid receptors in the brain • Mu-opioid receptors are responsible for the “high” or “buzz”

13. Naltrexone/Vivitrol for Opioid and Alcohol Dependence • Full MU opioid receptor ANTAGONIST No opioid effect

14. 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

15. Audience? • How many of you work with medications in your treatment programs? • How has your experience been with XR-NTX (Vivitrol)? • What are the issues you would like to discuss in today’s workshop?

16. Learning Objective #2 Identify at least one benefit of using mat

17. Evaluation Design • Treatment Outcome Data • Los Angeles County Participant Reporting System (LACPRS) • Patient Response to Vivitrol • Medically Assisted Treatment Survey (MATS) • Urge to Drink Scale (UDS) • Counselor Attitudes

18. Results and Conclusions Results Significant at p<.05 or better

19. Limited Side Effects Proportion Reporting Side Effect for Weeks 1 – 4 After First Dose

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

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

22. Engagement & Completion Rates for Vivitrol and Post Hoc (TAU) Clients Engagement and Completion Rates of Vivitrol Treatment Clients vs. TAU Treatment Clients

23. 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)

24. 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)

25. XR-NTX & Pos Compliance • Positive Compliance = Discharge status • Vivitrol group (78.4%) • Comparison group (60%) • Predictors included • XR-NTX (p < .001) • OR (95% CI) = 2.766 (1.665 – 4.595) • Age at first use (p < .01) • OR (95% CI) = 1.062 (1.018 - 1.109) • Employment activities (p < .01) • OR (95% CI) = .318 (.134 - .755)

26. Audience? • Have you tried implementing an MAT? • If yes: • What barriers did you experience? • What successes did you have? • If no: • What barriers do you expect to experience? • What successes do you hope to have? • What do you think promotes/inhibits an individual seeking MAT at a treatment center?

27. Learning Objective #2 Identify disparities in access to mat

28. What is a Health Disparity? • Population-specific differences in • the presence of disease • outcome of disease • quality of health care • access to health care services • Commonly viewed through the lens of race and ethnicity, but also includes SES, age, geographic location, gender, disability status, and sexual orientation (HRSA, 2014; Kaiser Family Foundation, 2008)

29. Health Disparities & Race/Ethnicity Compared to the non-Hispanic whites, racial/ethnic minority populations: • Lower prevalence of SUD, anxiety, mood disorders but an anxiety and mood disorder that persists for a longer duration (SAMHSA, 2012; Breslau et al., 2005.) • Less satisfied with SUD treatment services (Marsh et al, 2009; Niv et al, 2009) • Less likely to complete SUD treatment (Bluthenthal et al, 2007; Guerrero et al, 2013) • Experience more medical and social consequences from substance use (NIDA, 2008) • May receive less innovative evidence based treatments such as MATs (Knudsen & Roman, 2009)

30. Treatment Access & Gender Bottom line: Women with SUD have lower levels of help-seeking compared to men. Source: Grella & Stein, 2013. NESARC Wave I sample with past-year alcohol or other drug dependence; refers to any type of help received in lifetime; N = 1,262; p < .001

31. Treatment Outcomes & Gender • It is unclear if gender predicts SUD Tx outcomes • Characteristics associated with gender may have a greater impact on women’s treatment outcomes: • Co-occurring psychiatric disorders • History of abuse or trauma • Socioeconomic status, employment • Parenting and childcare responsibilities Source: Grella & Stein, 2013. NESARC Wave I sample with past-year alcohol or other drug dependence; refers to any type of help received in lifetime; N = 1,262; p < .001

32. What causes a Health Disparity? • The way the healthcare systems are organized and operate can contribute to differences • Patients attitudes and behaviors • Health care providers’ biases, prejudices and uncertainties when treating minority groups Institute of Medicine, 2002

33. So what? • Inequities in the health care system result in lost productivity or use of services at a later stage of illness, there are health and social costs that affect us all Kaiser Family Foundation, 2008

34. Disparities in MAT utilization Less likely to provide MATs: • Publically-funded SUD Tx programs • Use of XR-NTX: 8% public vs. 18% private • Outpatient-only treatment settings • Programs that receive a large proportion of CJ referrals • Lack of knowledge, recovery status, and counselor credential predict MAT utilization Abraham, Kundsen, Reickmann, Roman, 2013; Knudsenm Abraham, Oser, 2012; Roman, Abraham, Knudesen, 2011

35. 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

36. Disparities in Access to XR-NTX? • Are XR-NTX recipients different from the “average” patient seeking Opioid or Alcohol treatment services in LA County? • Were there any disparities in access to XR-NTX recipients by racial/ethnic or gender groups?

37. Methods • Used 2010-2013 admission records to compare XR-NTX patients to LA County patients seeking treatment for alcohol or opioids • Examined differences in treatment modality, race/ethnicity, SUD history and gender

38. Use of XR-NTX in LA County Treatment Modality p < 0.05

39. Use of XR-NTX in LA County Substance of Use p < 0.05

40. Use of XR-NTX in LA County Bottom line: XR-NTX recipients appear to have a more substantive SUD history as compared to the typical patient in LA County.

41. Use of XR-NTX in LA County Bottom line: Racial/ethnic minorities were under-represented among Vivitrol recipients.

42. Use of XR-NTX in LA County Gender by patients seeking Alcohol Tx p < 0.05

43. Use of XR-NTX in LA County Gender by patients seeking Opioid Tx p < 0.05

44. Summary of Findings • Treatment providers may have promoted XR-NTX to the patients with more severe SUD histories • Men and racial/ethnic minorities were 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.

45. Learning Objective #3 Describe at least one association between gender and subsequent Vivitrol doses

46. Studies on Gender and NTX • Results of studies on effectiveness of oral NTX by gender are mixed • Hernandez-Avila et al (2006) suggests that oral NTX may be more effective in men than women • Baros et al (2008) and Greenfield et al (2010) both found that NTX was effective in both men and women

47. Studies on Gender and Oral NTX cont. • O’Malley et al (2000) found that women were more likely to report nausea led to low adherence and discontinuation • Suh et al (2008) found that women more likely to discontinue oral NTX treatment with prior severe psychiatric disorder or nausea

48. Participant Demographics by Gender

49. SUD Characteristics by Gender *p<.05; **p<.01.

50. Treatment Characteristics by Gender • *p<.05; **p<.01 b SUD=substance use disorder.