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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 1 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 2 Learning Objectives 1. Define medically assisted treatment 2. Identify at least one benefit of using medically assisted treatments, such as XR-NTX, among alcohol or opioid users 3. Identify disparities in access to XR-NTX 4. Describe at least one association between gender and subsequent doses of XR-NTX for alcohol use disorders 3 Learning Objective #1 DEFINE MEDICALLY ASSISTED TREATMENT 4 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 5 Partial/Full Agonist, Antagonist, What’s the Difference? 6 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 7 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 8 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 9 No opioid effect Full MU Agonist: Partial MU Agonist: Full MU Antagonist: Methadone Buprenorphine Naltrexone •Naltrexone has the highest receptor BINDING AFFINITY, then buprenorphine, then methadone 10 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 11 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” 12 Naltrexone/Vivitrol for Opioid and Alcohol Dependence • Full MU opioid receptor ANTAGONIST No opioid effect 13 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 14 Audience? • How many of you work with medications in your treatment programs? • How has your experience been with XRNTX (Vivitrol)? • What are the issues you would like to discuss in today’s workshop? 15 Learning Objective #2 IDENTIFY AT LEAST ONE BENEFIT OF USING MAT 16 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 17 Results and Conclusions Results Significant at p<.05 or better 18 Limited Side Effects Proportion Reporting Side Effect for Weeks 1 – 4 After First Dose 19 Participant Characteristics Categorical Variable Gender (Female) Race/Ethnicity White African American Latino Other Criminal Justice Involvement (yes) Homeless status (yes) Employment Activities (yes) Program Type (Outpatient) Mental Illness* (yes) Vivitrol Group (% yes) 55.3% Post-hoc TAU Group (% yes) 56.8% 41.1% 13.2% 41.1% 4.7% 31.6% 40.5% 10% 35.3% 44.7% 43.7% 12.1% 40% 4.2% 33.2% 35.3% 14.2% 34.7% 32.1% Statistic X2 = 0.096 X2 = 0.323 X2 = .108 X2 = 1.118 X2 = 1.583 X2 = .012 X2 = 6.407 *Lifetime report of mental illness differed between groups; p<.01 20 Participant Characteristics Vivitrol Group Post-hoc TAU Group Mean (sd) Mean (sd) Age at Admission 37.2 (9.5) 36.8 (10.7) t(374) = -.469 Age at First Use 17.1 (6.3) 17 (6.1) t(378) = -.173 Days of Primary Drug in the Last 30 8.2 (9.5) 10.2 (11.3) t(378) = 1.877 # of Prior Treatment Episodes 2.2 (3.7) 2 (6) t(378) = -.463 Days on Wait List* 7.2 (13.6) 3.7 (10.5) t(378) = -2.826 Age at Admission 37.2 (9.5) 36.8 (10.7) t(374) = -.469 Age at First Use 17.1 (6.3) 17 (6.1) t(378) = -.173 Continuous Variable Test Statistic *Days spent on the wait list significantly differed between the groups p<.001. 21 Engagement & Completion Rates for Vivitrol and Post Hoc (TAU) Clients Engagement and Completion Rates of Vivitrol Treatment Clients vs. TAU Treatment Clients 22 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) 23 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) 24 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) 25 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? 26 Learning Objective #2 IDENTIFY DISPARITIES IN ACCESS TO MAT 27 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) 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) Treatment Access & Gender Did not seek help 100% Sought help 80% 72 69.5 60% 76 40% 20% 28 30.5 24 0% Total Men Women 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 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 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 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 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 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 Disparities in Access to XR-NTX? 1. Are XR-NTX recipients different from the “average” patient seeking Opioid or Alcohol treatment services in LA County? 2. Were there any disparities in access to XR-NTX recipients by racial/ethnic or gender groups? 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 Use of XR-NTX in LA County 100% Treatment Modality XR-NTX Patients 80% LAC Patients 67% 60% 40% 49% 32% 17% 20% 19% 16% 0% Outpatient p < 0.05 Residential Detoxification Use of XR-NTX in LA County 100% Substance of Use 80% XR-NTX Patients 74% LAC Patients 63% 60% 40% 30% 18% 20% 8% 7% 0% Alcohol p < 0.05 Heroin Other Opiates Use of XR-NTX in LA County (M + SD) XR-NTX Alcohol (N = 438) LAC Alcohol (N = 31,554) XR-NTX Opioid (N = 171) LAC Opioid (N = 18,177) Age 40.5 (9.836) 38.6 (14.347) 36.1 (11.587) 40.3 (13.474) Age First used 16.7 (5.993) 17.7 (6.708) 21.8 (9.667) Days Used Past Mo 13.5 (11.850) 9.8 (11.157) 11.1 (12.426) 20.6 (12.054) 2.4 (5.632) 1.2 (3.378) # of Prior Tx Episodes 4.2 (5.393) 22.1 (8.833) 2.7 (4.036) All findings significant at p < .01 Bottom line: XR-NTX recipients appear to have a more substantive SUD history as compared to the typical patient in LA County. Use of XR-NTX in LA County XR-NTX Alcohol (N = 438) LAC Alcohol (N = 31,554) XR-NTX Opioid (N = 171) LAC Opioid (N =18,177) Non-Hispanic White 45.9% 26.3% 66.1% 54.9% Black or African American 11.6% 27.9% 3.5% 8.3% Latino / Hispanic 36.3% 39.8% 23.4% 31.9% Asian/Pacific Islanderi 0.9% 2.4% 1.2% 1.2% American Indian/Alaska Nativei 0.7% 1.2% 0.6% 0.8% Other/Mixedi 4.6% 2.4% 5.3% 2.9% Race i Due to small sample sizes, a chi-square was conducted on a collapsed “Other Race/Ethnicity” category. This Race/Ethnic group contained individuals who identified as either American Indian, Asian/Pacific Islander or Other/Mixed Race. Analysis resulted in “Other Race/Ethnicity” comprising of 6.2% Vivitrol Alcohol vs. 6% LAC Alcohol as well as 8.3% Vivitrol Opioid vs. 4.9% LAC Opoids. p < 0.01 Bottom line: Racial/ethnic minorities were under-represented among Vivitrol recipients. Use of XR-NTX in LA County 100% Gender by patients seeking Alcohol Tx 80% XR-NTX Patients LAC Patients 61% 60% 52% 48% 40% 40% 20% 0% p < 0.05 Men Women Use of XR-NTX in LA County 100% Gender by patients seeking Opioid Tx 80% 68% 60% XR-NTX Patients LAC Patients 54% 46% 40% 32% 20% 0% p < 0.05 Men Women Summary of Findings • Treatment providers may have promoted XRNTX 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. 44 Learning Objective #3 DESCRIBE AT LEAST ONE ASSOCIATION BETWEEN GENDER AND SUBSEQUENT VIVITROL DOSES 45 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 46 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 47 Participant Demographics by Gender Total (N=465) Male (N=223) Female (N=242) % 45.9 9.7 36.7 7.7 % 43.5 7.2 37.8 11.5 % 48.1 11.9 35.7 4.3 37.7 (10.2) 38.2 (10.4) 37.0 (9.9) Parent of child <age 18** 55.1 42.3 65.1 Homeless at treatment admission 38.1 37.5 38.7 Under criminal justice supervision* 34.5 38.9 29.8 Mental illness diagnosis* 46.3 33.2 57.9 31.6 20.2 41.7 Variable Race/Ethnicity* White African American Latino Othera Age at treatment admission Prescribed medication for MI** *p<.05; **p<.01 aOther race/ethnicity includes multi-racial, Native American & Asian 48 SUD Characteristics by Gender Total (N=465) Male (N=223) Female (N=242) Alcohol problems 75.1 73.5 76.4 Opiate problems 24.9 26.5 23.6 Primary substance of use ** Alcohol Opiates Other 50.6 20.7 28.8 54.3 26.2 19.5 47.2 15.7 37.0 Secondary substance of use ** Alcohol Opiates Other 18.0 7.4 74.6 14.8 3.8 81.4 20.9 10.6 68.5 Variable Prescribed XR-NTX for: *p<.05; **p<.01. 49 Treatment Characteristics by Gender Total (N=465) Male (N=223) Female (N=242) Outpatient 33.1 26.7 38.9 Residential 61.5 67.1 56.4 Detoxification 5.4 6.2 4.7 Days on SUD b treatment waiting list 8.2 (14.8) 8.4 (12.2) 8.0 (16.9) Average XR-NTX doses received 2.5 (1.7) 2.5 (1.6) 2.5 (1.8) Variable Treatment modality * *p<.05; **p<.01 b SUD=substance use disorder. 50 Clinical Characteristics by Gender (1) Total (N=220) Male (N=110) Female (N=110) Week 1 2.1 (1.3) 1.9 (1.4) 2.2 (1.3) Week 2* 1.1 (1.2) 0.9 (1.1) 1.3 (1.2) Week 1** 85.5 79.0 92.0 Week 2** 57.2 46.4 68.0 Week 1 39.5 36.0 43.0 Week 2** 28.9 19.6 38.1 Side Effects Reported Average number of side effects Any side effects Headache *p<.05; **p<.01 51 Clinical Characteristics by Gender (2) Total (N=220) Male (N=110) Female (N=110) Week 1 55.9 49.0 61.0 Week 2 27.3 23.7 30.7 Injection site reaction Week1 Week 2 34.0 14.9 31.0 11.3 37.0 18.6 Nausea Week 1 Week 2 46.5 20.6 44.0 17.5 49.0 23.7 Side Effects Reported Fatigue *p<.05; **p<.01 52 Reduced Urge to Drink/Use by Gender 30 Women Men 25 20 15 19.2 18.7 A score of 10 or more indicates danger of relapse. 10 8.9 7.3 5 6.2 0 Week 0 Week 1 Week 2 Based on the Urge to Drink/Use Scale, which is scored from 0 to 30. 53 Qualitative Findings Total Male Female Percent who had questions or concerns about XR-NTX in week 1, 2 or 3 (e.g., regarding adverse events, liver concerns, efficacy of XR-NTX; medication interactions) 18.9% 21.2% 16.8% Percent reporting positive response to XRNTX (i.e., reduced cravings for substances including nicotine) 12.0% 11.7% 12.2% Respondents were asked “Have you noticed any other changes from using Vivitrol”? ”Do you have any questions or concerns about Vivitrol?” No statistically significant differences between men and women 54 Qualitative Findings Concerns/Problems Mild and/or transient Severe No Severity “trouble sleeping on the second day” “slight redness at injection site” “unable to get out of bed” “pain at injection site that went on forever” “I’ve been eating more, not as satisfied with food; adding more salt and pepper to food” “appetite decreased” Related to Abstinence? “irritable”, “moody”, “shakiness” Not attributed to Vivitrol “I’ve been jittery, but don’t think it’s because of the Vivitrol” Respondents were asked “Have you noticed any other changes from using Vivitrol”? ”Do you have any questions or concerns about Vivitrol?” 55 Summary of Findings on Gender – Based on the findings, women may have a greater need for SUD treatment that addresses co-occurring mental health problems as well as parenting needs – Women may also have a greater need for additional support in managing early side effects – No differences in the total number of injections received – Despite quantitative findings that women had more side effects, there were no differences in the number of doses obtained by gender. – Qualitative findings seem to suggest similar experiences with XR-NTX 56 Put Your Collaborative Thinking Caps On! 57 To Discuss • Would MAT work in your facility? • What MATs could work for your program and treatment population? • What if you implemented MAT and noticed… – More men compared to women were receiving MAT? – A large proportion of some race/ethnic group were not receiving MAT? 58 Conclusions • Although no causal conclusions can be made, Vivitrol was associated with increases in – Treatment engagement – Treatment retention – Positive compliance in treatment – Reductions in use were noted 59 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 60 Acknowledgements • Could not have done this work without: – Loretta L. Denering, MS – Diane Herbeck, MA – Eva Vasquez – Reham Abdel Maksoud, MBBS – Stefanie Weimann, MA – Dave Bennett, BA – Mary-Lynn Brecht, PhD – Richard A. Rawson, PhD 61 Thank You! Desiree A. Crevecoeur-MacPhail, Ph.D. (310) 267-5207 email: [email protected] 62