CTN Research Update. National Advisory Council on Drug Abuse May 8, Betty Tai, Ph.D. Center for the Clinical Trials Network

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1 CTN Research Update National Advisory Council on Drug Abuse May 8, 2013 Betty Tai, Ph.D. Center for the Clinical Trials Network

2 CTN Steering Committee

3 NIDA - CCTN

4 NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) CTN goals and projects are aligned with NIDA priorities: Revive medical involvement in drug abuse treatment Translate research into practice Increase and enhance the use of the CTN as a platform for additional types of research and training

5 Timeline for Active and Upcoming CTN Trials Revised 05/06/ POATS F/UP (CTN0030A3) STRIDE (CTN0037) SMART-ED (CTN0047) CURB (CTN0048) HOPE (CTN0049) START F/UP (CTN0050) X:BOT (CTN0051) BRAC-Pilot (CTN0052) BRAC-Main (CTN0058) ACCENT (CTN0053) ADAPT-MD (CTN0054) CHOICES (CTN0055) J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O Concept/Protocol Development Preparation for Implementation Randomization Treatment+Follow-up of Last Participant Data Lock

6

7 Pharmacotherapy to Treat SUD: Efficacy/Effectiveness Studies CTN-0048 CURB: Cocaine Use Reduction with Buprenorphine CTN-0052 BRAC: Buspirone for Relapse-Prevention in Adults with Cocaine Dependence CTN-0053 ACCENT: Achieving Cannabis Cessation Evaluating N-Acetylcysteine Treatment CTN-0054 ADAPT-MD: Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Dependence

8 CTN-0048 CURB: Cocaine Use Reduction with Buprenorphine PI: Walter Ling, M.D. (UCLA/CTN Pacific Region Node) Aim is to assess the safety and effectiveness of buprenorphine (BUP), in the presence of extended release naltrexone (XR- NTX), for the treatment of cocaine dependence Participants are cocaine-dependent adults with opioid use/abuse/dependence history Randomization to receive 8 weeks of: 1. XR-NTX + 16 mg BUP 2. XR-NTX + 4 mg BUP 3. XR-NTX + placebo

9 CTN-0048 CURB: Cocaine Use Reduction with Buprenorphine Trial enrolled 302 participants at 11 sites, from September 2011 to November 2012 Last follow-up visit completed March 2013 Database lock anticipated in May 2013 Final study report anticipated in September 2013

10 Pharmacotherapy to Treat SUD: Comparative Effectiveness Studies CTN-0051 X:BOT: Extended-Release Depot Naltrexone vs. Buprenorphine for Opioid Treatment CTN-0054 ADAPT-MD: Combine Extended Release Depot Naltrexone + Bupropion vs. Matched Placebos for Methamphetamine Dependence CTN-0055 CHOICES: Comparing Treatments for HIV- Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

11 The Break-Even Point Potential lives saved through quality improvement the break-even point for a drug that reduces mortality by 20 percent Woolf & Johnson: Annals of Family Medicine 2005; 3(6):

12 Vivitrol October 13, 2010: FDA approved Vivitrol (extended-release injectable naltrexone) for the treatment of opioid dependence Already marketed for alcohol dependence Potential for other indications Combination with other medications Place in spectrum of available treatments: compared to methadone and buprenorphine Limited to special patient populations?

13 Adjunctive Treatments for SUD Specialty Care Providers CTN-0037 STRIDE: Stimulant Reduction Intervention Using Dosed Exercise CTN-0044 Web-Delivery of Evidence-Based Psychosocial Treatment for SUD CTN-0046 S-CAST: Smoking Cessation and Stimulant Treatment

14 CTN-0044 Web-Delivery of Evidence-Based Treatment for SUD PI: Edward Nunes, M.D. (Columbia/CTN Greater New York Node) Participants are adults seeking outpatient treatment for substance abuse minimal exclusionary criteria Random assignment: 1. Treatment as Usual (TAU) 2. Modified TAU + Therapeutic Education System (TES) TES substituted for 2 hours/week of usual clinician-delivered treatment 10 sites enrolled a total of 507 participants

15 Therapeutic Education System (TES) (Bickel, Marsch et al., Exp Clin Psychopharm, 2008) CTN-0044 Comprehensive, computer-assisted, psychosocial treatment delivered by internet: Based on Community Reinforcement Approach & Contingency Management Automated web-based platform high dissemination potential 32 core modules (~weeks 1-8) 30 optional modules (~weeks 9-12) Prize-based incentives targeting abstinence and module completion

16 CTN-0044 Results Abstinent at baseline Non-abstinent at baseline TES at least as good as TAU among participants abstinent at baseline TES doubles abstinence (OR=2.18) among participants non-abstinent at baseline TES also reduced dropout from treatment (HR=0.72)

17 Blending Team & Plan NIDA & SAMHSA Product Plan July 1, 2013 Target Audiences Primary care and integrated care providers (e.g., FQHCs and hospital settings) Addiction & specialty treatment providers Product Launch Summer 2014

18 HIV CTN-0049 HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV- Infected Drug Users CTN-0055 CHOICES: Comparing Treatments for HIV- Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study CTN-0056-Ot Testing and Linkage to HIV Care in China Project AWARE HIV Rapid Testing and Counseling in STD Clinics in the U.S.

19 CTN-0049 HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users PI: Lisa Metsch, Ph.D. (Columbia/CTN Florida Node Alliance) AIM: To evaluate strategies for achieving HIV virologic suppression among HIVinfected drug users recruited from the hospital setting

20 CTN-0049 HOPE Conceptual Model COVARIATES Socio-demographics Housing Mental health status Alcohol & drug use History of HIV primary care History of ART Perceived health status History of Drug Treatment INTERVENTION Use of PRIMARY CARE ART ADHERENCE VIROLOGIC SUPPRESSION Moderating effect Primary Outcome Proximal Outcome SUBSTANCE ABUSE TREATMENT Mechanism of main effect

21 CTN-0049 HOPE: Overview Participant-level randomization 800 HIV-infected inpatients to be randomized at 10 sites (hospitals) in the U.S.

22 Long-Term Follow-Up Studies CTN-0030-A3 Long-Term Follow-Up of the Prescription Opioid Addiction Treatment Study (POATS) CTN-0050 Long-Term Follow-Up of the Starting Treatment with Agonist Replacement Therapies (START) Study

23 Chronic Care Management for Substance Use Treatment of addiction should follow a chronic model of disease and maintain continued care for patients tailored to the severity and the substance abused. Volkow N.D. & Li, T.K. Nature Neuroscience 8 (11), 1429 (2005) N. Volkow: NIDA Blending Conference, 2010

24 Unreachable Star?

25 Recent U.S. Health Care Reform Legislation Mandates that benefits measure up to medical and surgical benefits Affordable Care Act (2010) Children s Health Insurance Program Reauthorization Act (2009) Mental Health Parity and Addiction Act (2008) Requires essentially all health plans to offer, by 2014: Prevention, Early intervention, and Treatment for the full spectrum of substance use disorders

26 How Recent U.S. Health Care Reform Legislation Impacts SUD Care Drives SUD care to primary care settings for initial identification and treatment Supports a chronic care model for all diseases (e.g., diabetes, hypertension, SUD) Requires outcome measures in a recovery/relapse disease model vs. just acute episodic care

27 Medical Benefit for Diabetes Care Physician visits Clinic visits Home health visits Insulin and 4 other meds Glucose tests, monitors, supplies HbA 1c, eye, foot exams 4x/year Smoking cessation Personal care visits Language interpreter

28 NIDA Taskforce on Chronic Care Management for SUD in Primary Care 2012 Lead: Dr. Tom McLellan

29 Diagnostic Prevalence Very Serious Use In Treatment ~ 2,300,000 ~12% more Qualify! Harmful Use ~ 45,000,000 Qualify! Little/No Use Little or No Use

30 US Health Reform Affordable Care Act 2010 Very Frequent Use Expanded Role For Specialty Care Major NEW Role For Primary Care Very Rare Use

31 Care of Substance Use Disorders Very Frequent Use Chronic Care Model Office-Based PC Treatment Very Rare Use Prevention & Early Intervention

32 NIDA Taskforce on Chronic Care Management for SUD To bring clinicians and researchers together to focus on real-world patients with multi-faceted health conditions For the following four goals: Natural history of a disease Treatment effectiveness Patient safety Health care process quality improvement (Federal Register, Feb 2012 ref)

33 1 For now (until research findings arrive) Develop and adopt Electronic Health Records (EHRs) to facilitate: 1. Screening and Brief Interventions (SBI) in primary care 2. Registries to define parameters for Chronic Care Management research

34 CTN-0047 SMART-ED: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments Southwest & Pacific Northwest Nodes Lead Investigators: Michael Bogenschutz, M.D. & Dennis Donovan, Ph.D. Project Director: Alyssa Forcehimes, Ph.D.

35 Multiple Chronic Conditions

36 Prevalence of Substance Use among Adults with Diabetes Among adults with diabetes: Approximately 20% are current cigarette smokers 50-60% are current alcohol users Adults with diabetes and comorbid substance use disorders have a high risk for: Developing and experiencing additional medical comorbidities and hospital readmissions More adverse outcomes U.E. Ghitza, L.T. Wu, B. Tai. Substance Abuse Rehabilitation 2013; 4:3-10.

37 CTN-0057-Ot SBIRT-PC: Screening, Brief Intervention, and Referral to Treatment in Primary Care An add-on study to Duke University s Southeastern Diabetes Initiative, a CMS Innovation Award Project

38 International Collaborations: Research and Training CTN-INVEST Fellowship 12-month term Since 2007, 16 fellows from 14 countries Mexico Established a network to conduct SUD clinical trials modeled on the CTN Funded by Dept. of State, working with researchers from Univ. of Miami Successfully completed a pilot RCT based on CTN-0021 study; second protocol to follow Italy MOU with Italian government Funds for fellowships within CTN Provided faculty for Italian national SUD counselor training Canada Major consultation for CIHR s CTN UBC a site for CTN-0055 pilot study China CTN-0056-Ot platform study Peru MOU in development follows Italian model

39 NIDA-CTN Data Share Public website ( for 29 completed CTN studies Posted no later than 18 months after data lock or acceptance of the primary manuscript Clinical Data Interchange Standards Consortium (CDISC) format or Case Report Form (CRF) format Researchers (from 44 countries) have downloaded de-identified data from completed CTN studies (2,000 hits)

40 The CTN Dissemination Library

41

42 Longitudinal Disease and Treatment Registry for SUD: Why? Broader range of SUD patients Co-morbidities, poly-drug use problems Long-term outcomes vs. acute or short-term treatment Larger database (N>>10,000) vs. small database (N<< few 100s) Risks/benefits Cost-effectiveness

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