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Clinical Trials Network Bridging the Gap between Science & Practice:

Translating Addiction Research to Benefit Patients. Clinical Trials Network Bridging the Gap between Science & Practice:. Betty Tai, Ph.D. Director, Center for the Clinical Trials Network October 23, 2011. B. Tai 2011. U.S. National Institutes of Health. 27 Institutes and Centers

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Clinical Trials Network Bridging the Gap between Science & Practice:

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  1. Translating Addiction Research to Benefit Patients Clinical Trials Network Bridging the Gap between Science & Practice: Betty Tai, Ph.D. Director, Center for the Clinical Trials Network October 23, 2011 B. Tai 2011

  2. U.S. National Institutes of Health • 27 Institutes and Centers • Annual budget $31.2 Billion (2010) • About 1/3 budgeted for clinical research • NIDA Budget $1.06 Billion (2012) • 3% of NIH Budget • Research funding priorities • Public health demand • High risk research • Research lack of financial incentives • Vaccine development, Preventive medicine, Rare diseases, etc. B. Tai2011

  3. Clinical Research to Clinical Practice: Lost in Translation? “Enormous amounts of new knowledge are barreling down the information highway, but they are not arriving at the doorsteps of our patients….” Lenfant (2003), NEJM 349: 868 B. Tai 2011

  4. NIH ROADMAP 2003 “NIH aims to accelerate the pace of discovery and speed of application of new knowledge . . …… ultimately to the transfer of innovations to health care providers, and the public.” WWW.nihroadmap.nih.gov

  5. NIH Sets Forth Vision for Reengineering Translational Science “…….Millions of people are looking to science to deliver new and better ways to detect, treat, and prevent disease—and the scientific opportunities have never been greater. Consequently, the time is right to take bold action to transform the translational research enterprise. NIH’s vision for a new entity to do just that—the proposed National Center for Advancing Translational Sciences (NCATS)—is laid out in this Commentary,………..” Collins, Science Translational Medicine July 6, 2011 . B. Tai2011

  6. Domains of Research How does the brain work? What molecules/behavior manipulation affect which brain function? Are interventions safe, effective? For which disorders? The NIDA CTN Bench Bedside Practice T1-devise new treatment T2-treatment to practice How to optimally deliver treatments to patients? (clinician guidance) How to align systems to deliver cost-effective outcomes? (delivery guidance) What brain processes are involved in which disease for specific clinical observations? Adapted from John Rush’s presentation at a CTN Workshop -2007 B. Tai 2011

  7. Strategies to Accelerate T2 Infrastructure Building • Develop trial network, workforce • Develop and utilize bio-informatics • EHRs, e-health technologies • Harmonize regulatory requirements for human subject protection Research approaches • Focus on dissemination potential/products • Research questions address clinical care needs • Care providers included in research team • Outcome measures are clinically relevant • Assessment tools fit providers’ practice • Broad patient inclusion, in real world treatment settings • Large RCTs with power to detect moderate effects • Ancillary studies to inform “policy” makers IOM Report 2009: Transforming Clinical Research in the US B. Tai2011

  8. Translational ResearchNIDA’s Commitment • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2011

  9. Institute of Medicine, 1998 Bridging the Gap NIDA Clinical Trials Network ResearchPractice B. Tai 2011

  10. National Drug Abuse Treatment Clinical Trials Network 13 Nodes 57 affiliated Universities 200 + Clinical Care Providers (CTPs) Regional Research and Training Center (RRTC) State with Community Treatment Program (CTP) Appalachian Tri-State Node University of Pittsburgh Delaware Valley Node University of Pennsylvania Florida Node Alliance University of Miami Greater New York Node New York State Psychiatric Institute/New York University Mid-Atlantic Node The Johns Hopkins University Friends Research Institute, Inc. New England Consortium McLean Hospital Yale University Ohio Valley Node University of Cincinnati Pacific Northwest Node University of Washington Washington State University Pacific Region Node University of California, Los Angeles Southern Consortium Node Medical University of South Carolina Duke University Medical Center Southwest Node University of New Mexico Texas Node Univ. of Texas, Southwestern Med Cen. Western States Node University of California, San Francisco Oregon Health & Science University B. Tai 2011

  11. The Drug Abuse Treatment Community Rehab Centers Betty Ford Center Hazelden Foundation Caron Foundation Medical Care Kaiser Permanente VA Hospitals/medical homes General practices/Dental Clinics Pain/HIV clinics FQHCs “Drug free programs” Odyssey House Center for Drug-Free Living Walden House, Phoenix House Na’Nizhoozi Center Homeward Bound Methadone Clinics Evergreen Treatment Services Addiction Research & Treatment Corp. Bi-Valley Medical Clinic Hartford Dispensary Social Model Behavioral Model Medical Model B. Tai 2011

  12. CTN: Translate Research into Practice • Engaging Community providers in the research process will improve the acceptability/adoption of research results, • Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments, • Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs. B. Tai2011

  13. National Institute on Drug Abuse Portfolio FY 2010 Actual Basic & Clinical Neuroscience & Behavioral Research -- 46% Epidemiology, Services & Prevention Research -- 23% Pharmacotherapies & Medical Consequences -- 12% Clinical Trials Network -- 4% Intramural Research -- 8% RM&S -- 6% B. Tai 2011

  14. SUD Translational Research at NIH:

  15. Translational ResearchNIDA’s Commitment • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2011

  16. CTN by the (Cumulative) Numbers B. Tai 2011

  17. The CTN Trials (1999-now) Pending, Development & Review (3) Data Collection (6) Data Analysis (2) Publication & Dissemination (25) CTN 0022 CTN 0023 CTN 0024 CTN 0025 CTN 0026 CTN 0049 CTN 0051 CTN 0052 CTN 0037 CTN 0044 CTN 0046 CTN 0047 CTN 0048 CTN 0050 CTN 0027 CTN 0031 CTN 0001 CTN 0002 CTN 0003 CTN 0004 CTN 0005 CTN 0006 CTN 0007 CTN 0008 CTN 0009 CTN 0010 CTN 0011 CTN 0012 CTN 0013 CTN 0014 CTN 0015 CTN 0016 CTN 0017 CTN 0018 CTN 0019 CTN 0020 CTN 0021 CTN 0028 CTN 0029 CTN 0030 CTN 0032 • 36 Multisite Studies address: • Pharmacotherapies • Behavioral Interventions • Integrated Therapies • HIV/HCV • Surveys B. Tai 2011

  18. Currently Enrolling Studies* • STRIDE-Stimulant Reduction Intervention using Dosed Exercise– CTN 0037 • Current Enrollment: 219/330 • Web Delivery of EBT – CTN 0044 • Final Enrollment: 507/500 (Ahead of Schedule) • S-CAST - Smoking - Cessation and Stimulant Treatment - CTN 0046 • Current Enrollment: 483/528 *Numbers as of October 22, 2011 B. Tai 2011

  19. More Currently Enrolling Studies* • SMART-ED –Screening, Motivational Assessment, Referral, and Treatment in Emergency DepartmentsCTN 0047 • Current Enrollment: 1040/1285 • CURB – Cocaine Use Reduction with BuprenorphineCTN 0048 • Current enrollment: 9/300 *Numbers as of October 22, 2011 B. Tai 2011

  20. Studies Launching Next • Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users - CTN 0049 • Naltrexone Extended Release Injection - CTN 0051 • A Randomized Controlled Trial of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence (BRAC) - CTN 0052 B. Tai 2011

  21. Completed CTN Pharmacotherapy Trials Adapted from Roger Weiss presentation 7/13/2011 B. Tai 2011

  22. CTN Pharmacotherapy Trials CTN 0010 • Context: • Increased heroin and pharmaceutical opioid • use among 12th graders • Usual Tx for Opioid addicted youth: • Detox and counseling • First RCT study of continued agonist Tx • in this young population Detox only Bup/NX 12 weeks B. Tai 2011

  23. Prescription Opioid Addiction Treatment Study Conclusions • Prescription opioid-dependent patients most likely to reduce opioid use during bup/nx treatment • Likelihood of unsuccessful outcome is extremely high when tapered off bup/nx, even among patients receiving counseling in addition to medical management • Weiss RD et al., Archives of General Psychiatry, in press B. Tai 2011

  24. On Buprenorphine/Naloxone Practice • Can be used safely and effectively in community treatment settings (Amass et al, 2004) • More patients stay in care and complete care with Bup/Nal (Ling et al, 2005) • 7 day taper is as effective as a 30 day taper (Ling et al, 2009) • Treatment Programs continue to use • Maryhaven, Columbus OH (Brigham et al, 2008) • Phoenix House, NY, NY (Collins et al, 2007) • Betty Ford Center, Palm Spring, CA • Kaiser-Permanente NW, Portland, OR • 100+ maintenance patients B. Tai 2011

  25. CTN Behavioral Therapy Trials • MI or CM: Lower-cost motivational incentives • MI/MET: Motivational interviewing & enhancement • Adults, pregnant women, Spanish speakers • Seeking Safety: Trauma counseling for women • BSFT: Brief Strategic Family Therapy • Adolescent • STAGE-12: Twelve Step Facilitation Therapy • Reducing HIV/HCV risk behavior • Injection drug use, sex risks for women & men • Seek & test • STRIDE: Exercise to reduce stimulant use • SMART-ED: SBIRT in the ED for SUD B. Tai 2011

  26. MET for Spanish-Speaking Substance UsersCTN 0021 B. Tai 2011

  27. MET for Spanish-Speaking Substance UsersCTN 0021 • Recruited 436 representative population of US Hispanics across 5 CTP sites • Bilingual investigators/therapists/RAs • Translation of 70% of project materials • Consent forms • CRFs • Assessment instruments • Intervention manual • Bilingual Training and fidelity monitoring • Shovel-ready project for Spanish language international collaboration - Mexico B. Tai 2011

  28. Recruitment and Enrollment Brief Baseline Assessment Random Assignment Offer Rapid Testing with RESPECT Counseling Offer Rapid Testing with Minimal Counseling Offer Referral for Testing in Community Client post-intervention data collection - CTN 0032: HIV Rapid Testing and Counseling in Drug Treatment What is the more effective testing strategy to ensure they get HIV tested and receive their results? What is the more effective testing strategy to reduce their risk behaviors? First participant randomized: 01/05/2009 Last participant completed 12/31/2009 Total Participants Randomized: 1281 B. Tai 2011

  29. CTN Ancillary Studies • Cost analysis (NIDA DESPR: Services Research Branch) • CTN 0004, 0005, 0006, 0007, 0010, 0030, 0032, 0046 • Genetics – (NIDA Genetics Consortium) • CTN 0027 • Training methods(NIDA DCNBR: Behavioral & Integrative Treatment Research Branch) • CTN 0014 • Psychometric study (NIAAA) • CTN 0031 • Brain Imaging study (NIDA DCNBR: Clinical Neuroscience Branch) • CTN 0030 B. Tai 2011

  30. CTN Secondary Analysis Studies • Scientific Rationale • Secondary clinically useful information • E.G. Who drops out when • Mediators and moderators and their interactions at baseline • Scientist Rationale • Investigators (especially junior) benefit • A platform for independent research support • Training opportunities (e.g. K awards) • Economic Rationale • Inexpensive methods to address important questions • More precisely define future research steps • Shorten measures to save future costs B. Tai 2011

  31. Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis From a Randomized Clinical Trial in NIDA’s Clinical Trials Network Denise A. Hien et al. American Journal of Psychiatry January 2010, Vol. 167, No. 1, 95-101 B. Tai 2011

  32. Researchers control the participant population in clinical trials for many good reasons… But study populations reflect a broader patient population B. Tai 2011

  33. Conclusions/Implications • PTSD severity reductions were associated with SUD improvement • Integrated PTSD/SUD treatments may be advantageous for patients with severe symptoms • For further study: • Men, mixed populations • Combat/military trauma • Other forms of integrated treatment Hein et al AJP Jan 2010, 167, 1, 95-101 B. Tai 2011

  34. Providing Implications for Practice “Findings bring into question the common practice of requiring patients with PTSD and substance use dis- orders to be abstinent from alcohol or drugs before commencing trauma work.” Back, SE Am J Psychiatry 167:1, January 2010 B. Tai 2011

  35. Translational ResearchNIDA’s Commitment • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2011

  36. CTN Dissemination Library • Continued increase in utilization • 2010: 52,016 pages viewed; & 15,219 unique visitors • New brochure available: http://ctndisseminationlibrary.org/CTNLibhandout2011.pdf • A new Blog…http://ctndisseminationlibrary.wordpress.com/ • RSS feed • News • Training B. Tai 2011

  37. Buprenorphine Treatment: A Training for Multi- disciplinary Addiction Professionals NIDA-SAMHSA Blending Products www.attcnetwork.org/explore/priorityareas/science/blendinginitiative/index.asp Short-Term Opioid Withdrawal Using Buprenorphine Buprenorphine Treatment for Young Adults Treatment Planning MATRS: Utilizing the Addiction Severity Index (ASI) to Make Required Data Collection Useful Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA-STEP) Motivational Incentives Suite: PAMI MIPRESTO MIIS B. Tai 2011

  38. CTN Data Sharing http://www.ctndatashare.org CTN 0001,0002,0003,0004,0005,0006,0007,0008,0009,0010,0011, 0012,0013,0014,0015,0016,0017,0018,0019,0020,0021,0028,0029,0030 • CDISC standardized • HIPAA Compliant • CTN Public data/documents include: • Data sets (SAS and ASCII) • Defined file (aka data dictionary) • Annotated Case Report Forms • Study protocol and reference to study publication of primary outcomes B. Tai 2011

  39. United States •India• UK • Canada • China • Spain • France • Malaysia • Bangladesh Turkey •Egypt• Poland • Nepal • Brazil • Afghanistan • Mexico • South Korea B. Tai 2011

  40. International Outreach: NIDA CTN INVEST Fellows • Create an international network of scientists • CTN serves as the training platform • Senior non-U.S. scientists and health administrators • 2007 (1), 2008 (3), 2009 (2) and 2010 (3) • Export CTN technology, identified future opportunities for collaboration and funding http://international.drugabuse.gov/research/fellowships_investCTN.html

  41. CTN Invest Fellows Australia (2009) Mexico (2010)* Ukraine (2010) Kosovo (2010) France (2010) Switzerland (2011) ** Colombia (2008) Chile (2009) Iran (2010)* Georgia (2007) Philippines (2008) China (2007, 2010) India (2007, 2009) * Funded by U.S. Department of State **Funded by University of Geneva B. Tai 2011

  42. Translational ResearchNIDA’s Commitment • Infrastructure • Research • Research utilization • CTN next decade B. Tai2011

  43. Build additional new Bridges: Integrated treatment with mainstream medical practices Develop new research paradigms: To study chronic disease management model for SUDs Adopt information technology Novel approaches to data collection, processing & storage, e.g. EHR /EMR & real-time EDC Data standardization, access, reporting Data privacy & confidentiality Future of the CTN-ACA 2010 B. Tai 2011

  44. EHR Development NIDA’s Proposed SUD EHR Small Core Set of Questions for Primary Care Setting Enlarged Core Set of Questions for SUD Treatment Setting B. Tai 2011

  45. Validated Core Questions - MU stage 2 Single question drug screen “How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons?” Smith PC, Schmidt SM, Allensworth-Davies D and Saitz R. A. Arch Intern Med 2010; 170(13):1155-1160 DAST-10 Have you used drugs other than those required for medical reasons? Do you abuse more than one drug at a time? Are you always able to stop using drugs when you want to? Have you had “blackouts” or “flashbacks” as a result of drug use? Do you every feel bad or guilty about your drug use? Does your spouse (or parents) ever complain about your involvement with drugs? Have you neglected your family because of your use of drugs? Have you engaged in illegal activities in order to obtain drugs? Have you ever experienced withdrawal symptoms (felt sick) when you stopped taking drugs? Have you had medical problems as a result of your drug use (e.g., memory loss, hepatitis, convulsions, bleeding, etc.? B. Tai 2011

  46. 1. Screening 2. Brief Assessment 3.Plan of Action 1-Item Screener Minimal or No Risk Low Intensity DAST-10 High Intensity Additional Questions Proposed CDS for SUD If score = 0 If score > 0 Adapted from G. Subramaniam, MD Sept 2011 B. Tai 2011

  47. NIDA’s gem? www.nida.nih.gov/CTN/Index.htm B. Tai 2011

  48. Data Share Stats CTN 0030: Only posted 3 months! Year CTN Trial Number B. Tai 2011

  49. New Resource – Assessments Tool • Detailed information on assessments (CRFs)that were used in CTN studies • Description of all assessments • Identifies CTN studies by either • specific assessments • all assessments within a particular CTN study • www.ctndatashare.org B. Tai 2011

  50. Welcome International Colleagues • Denmark Dr. Annette SØgaard Nielsen • People’s Republic of China Dr. Zunyou Wu • BrazilDr. Ronaldo Laranjeira Dr. Andre Miguel • Italy Dr. Roberto Mollica • Canada Dr. Nathalie Gendron • MexicoDr. Rodrigo Marin-Navarrete, Sr. Dr. Ana de la Fuente Martin Mr. José Carlos Fernández Mondragón • Nigeria Dr. AjibikeSalako-Akande Dr. Henry Daniyan Participated/presented in CTN International Forum 9/27/2011 CTN Steering Committee Meeting B. Tai 2011

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