1 / 45

Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network

NIDA. NATIONAL INSTITUTE ON DRUG ABUSE. NIDA Drug Abuse Treatment Clinical Trials Network The First Decade. Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network National Institute on Drug Abuse. Institute of Medicine, 1998. NIDA Clinical Trials Network.

chip
Download Presentation

Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. NIDA NATIONAL INSTITUTE ON DRUG ABUSE NIDA Drug Abuse Treatment Clinical Trials Network The First Decade Betty Tai, Ph.D. February 3, 2010 Director Center for the Clinical Trials Network National Institute on Drug Abuse

  2. Institute of Medicine, 1998 NIDA Clinical Trials Network Bridging the Gap ResearchPractice

  3. CTN Premises • Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs, • Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments, • Engage the providers in the research process will improve the acceptability/adoption of research results. B. Tai 2009 B. Tai 2010

  4. Council Report2/3/2010 • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2010

  5. Northern NE Node McLean/Harvard California/Arizona Node UCSF/U. Arizona Southwest Node U. New Mexico National Drug Abuse Treatment Clinical Trials Network Pacific Northwest Node U. Washington Oregon/Hawaii Node OHSU New England Node Yale New York Node NYU Appalachian Tri-State Node WPIC/U of Pitt. Long Island Node NY State Psych. Inst. Delaware Valley Node U. Pennsylvania Ohio Valley Node U. Cincinnati Mid-Atlantic Node JHU/MCV Pacific Node UCLA Southern Consortium Node MUSC Texas Node UT/S. Med Center Florida Node U. Miami 16 RRTCs & 240 CTPs across 37 States and Puerto Rico B. Tai 2010

  6. National Drug Abuse Treatment Clinical Trials Network Regional Research and Training Center (RRTC) State with Community Treatment Program (CTP)

  7. The Drug Abuse Treatment Community Rehab Centers Betty Ford Center Hazelden Foundation Caron Foundation Hospitals Kaiser Permanente VA Hospitals Mayo Clinic Mercy Hospital RWJ Medical Center “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 2010

  8. CTN Coordinating Centers Organizational design of a multisite trial is as important to its success as is the experimental design. Curtis Meinert, Controlled Clinical Trials 1, 305 (1981) “Science and process are equally important to ensure success of large prospective studies Timothy Sprosen, UK Biobank NIH New Models for Large Prospective Studies symposium (1/22/2010) B. Tai 2010

  9. CTN Coordinating Centers CTN Data and Statistics Centers • Provide statistical support for protocol design/analysis • Provide data management via electronic data capture • Monitor integrity and security of data CTN Clinical Coordinating Center • Provide centralized regulatory support, trial monitoring, training in clinical trials implementation procedures • Uniform handling of pharmaceuticals, laboratory and clinical supplies B. Tai 2010

  10. Center for the Clinical Trials Network B. Tai 2010

  11. Council Report2/3/2010 • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2010

  12. Pending, Development & Review Data Collection Data Analysis Publication & Dissemination CTN 0022 CTN 0023 CTN 0024 CTN 0025 CTN 0026 CTN 0037 CTN 0044 CTN 0046 CTN 0047 CTN 0048 CTN 0027 CTN 0031 CTN 0032 CTN 0014 CTN 0028 CTN 0030 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 0015 CTN 0016 CTN 0017 CTN 0018 CTN 0019 CTN 0020 CTN 0021 CTN 0029 The CTN Trials (1999-now) • Pharmacotherapies: 12 • Behavioral Interventions: 14 • HIV/HCV Interventions: 4 • Others: 3 B. Tai 2010

  13. A Decade of Growth: CTN by the (Cumulative) Numbers Randomized Participants Completed Trials Peer-Reviewed Articles B. Tai 2010

  14. CTN Studies in Development • STRIDE (CTN 0037): • Stimulant Reduction Intervention Using Dosed Exercise • Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders (CTN 0044) • S-CAST (CTN 0046) • Smoking Cessation and Stimulant Treatment • SMART-ED (CTN 0047) • Screening, Motivational Assessment, Referral and Treatment in Emergency Departments • CURB (CTN 0048) • Cocaine Use Reduction with Buprenorphine B. Tai 2009

  15. Highlighting CTN Pharmacological Therapy Trials • Buprenorphine (Suboxone) • CTN 0001, 0002 Bup/Nxvs Clonidine in detox • CTN 0027 Bup/Nxvs Methadone in maintenance • CTN 0010 Bup/Nxfor adolescents tapering • CTN 0030 Bup/Nxfor prescription opiate dependence • Osmotic-Release Methylphenidate (Concerta) • CTN 0029 Adult smokers • CTN 0028 Adolescents Substance users • Nicotine replacement in drug treatment • CTN 0009 • CTN 0029 B. Tai 2010

  16. 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 2010

  17. Highlighting 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 B. Tai 2009

  18. MET for Spanish-Speaking Substance UsersCTN 0021 B. Tai 2010

  19. Study Challenges and Opportunities CTN 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 B. Tai 2010

  20. 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 2010

  21. CTN American Indian Collaborations • Node initiated exploratory studies to develop collaborations with tribes and Native American treatment programs to explore methamphetamine use and co-occurring problems: • Southwest Node • Ohio Valley Node • Pacific Northwest Node • Oregon Hawaii Node

  22. 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 2010

  23. CTN Ancillary Studies CTN 0031: STAGE-12 • CTN 0031 A-1 • Identify the association between performance and neurotoxic oxidative stress level (by measuring antioxidants parameters in the plasma) • CTN 0031 A-2 • Validate the concept that frequency of risk drinking patterns a predictor for severity of AUDs in a clinical population • CTN 0031 A-3 • Identify organizational and counselor level factors that may impact the implementation process and possible adoption of STAGE-12 B. Tai 2009

  24. 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 2010

  25. 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 2010

  26. 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 2010

  27. Providing Implications for Practice Back, SE Am J Psychiatry 167:1, January 2010 B. Tai 2010

  28. Figure 1 B. Tai 2010

  29. Council Report2/3/2010 • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2010

  30. Research Utilization Process through which research findings are put in use in the form of programs and policies • Difficult • Slow • Not an action that begins when research is completed • Rather a two way concurrent process Everett Rogers, Diffusion of Innovations, 2003

  31. CTN Research Utilization Activities • Led by CTN Research Utilization Committee • Coordinate intra-CTN and intra-Node activities • Support and monitor the CTN dissemination library utilization • Serve as point of contact for • NIDA Blending Conference • SAMHSA ATTC Program • Major regional workshops in 2009 • June 2009 Pacific Region (Portland, Oregon) • October 2009 Appalachian Tri-state (Pittsburgh, Pa) • November 2009 Southern Consortium (Charlotte, SC) B. Tai 2010

  32. The CTN Dissemination Libraryhttp://ctndisseminationlibrary.org • Housed and maintained by Washington Node • Inaugural year 2003 • Library usage statistics B. Tai 2010

  33. 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 Treatment Planning MATRS: Utilizing the Addiction Severity Index (ASI) to Make Required Data Collection Useful Promoting Awareness of Motivational Incentives (PAMI) Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA-STEP) B. Tai 2010

  34. CTN Data Sharing http://www.ctndatashare.org • CTN 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0011, 0012, 0013, 0016, 0017, 0018, 0019, 0021, 0029 • 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 2010

  35. 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

  36. Council Report2/3/2010 • Infrastructure • Research • Research utilization • CTN next decade B. Tai 2010

  37. CTN RFA 2009 Stay Tuned… • Published – June 2009 • Proposals – November 2009 • Review – February 2010 • Council – May 2010 • Award – September 2010 B. Tai 2010

  38. Bring drug abuse treatment into mainstream medical practice Engage providers from medical settings Flexible research strategy/portfolio Seize new scientific opportunities Address emerging public health concerns Training platform for clinical workforce Facilitate research utilization Future of the CTNMission/Goals B. Tai 2010

  39. Current Future expansion CTP CTP CTP RRTC CTP CTP Future of the CTNInfrastructures ED ED PCP CTP Dental HMO CTP RRTC HIV HIV CTP CTP CTP CTP Optimal ratio of research $/infrastructure $ B. Tai 2010

  40. Future of the CTN Challenges and Opportunities • Information Technology • Novel approaches to data collection, processing & storage • EHR /EMR & real time EDC • Data standardization, access, reporting • Data privacy & confidentiality • Approaches to accommodate physiologic and genetic information B. Tai 2009 B. Tai 2010

  41. Future of the CTN Challenges and Opportunities • New statistical tools and techniques • adaptive design • simulation and modeling • large database mining • Innovative trial/study designs • large, simpler and longer trials • pragmatic trials , comparative effectiveness trials • subgroup analysis • Chronic Disease management model • treatment algorithm for continuing care B. Tai 2009 B. Tai 2010

  42. “What” and “for whom” questions “How” questions How to best practice based on efficacy and side effects, Decision questions How much time, training, and cost is entailed in the new treatment? Is the clinical benefit worth the cost? Is there a cost offset? Future of the CTNAsk a different research question For a Chronic disease like addiction, what is the first line treatment? Is there a next best treatment sequence at steps 2, 3, and 4? What sequence is best for whom? What is the long-term outcome after steps 1, 2, 3, and 4? Research questions that impact practice B. Tai 2010

  43. Future CTN Premises • Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs, • Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments, • Engage the providers in the research process will improve the acceptability/adoption of research results. • Address research questions that impact practice. B. Tai 2009 B. Tai 2010

  44. www.nida.nih.gov/CTN/Index.htm B. Tai 2009

  45. Q&A B. Tai 2010

More Related