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National Drug Abuse Treatment Clinical Trials Network

National Drug Abuse Treatment Clinical Trials Network. February 13, 2003 Betty Tai, Ph.D. Director, Center for the Clinical Trials Network, NIDA/NIH. Who could want a more lovely way To spend Valentine’s Day Than talking about how we may Implement protocols the CTN way. CTN’s Mission.

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National Drug Abuse Treatment Clinical Trials Network

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  1. National Drug Abuse TreatmentClinical Trials Network February 13, 2003 Betty Tai, Ph.D. Director, Center for the Clinical Trials Network, NIDA/NIH

  2. Who could want a more lovely way To spend Valentine’s Day Than talking about how we may Implement protocols the CTN way

  3. CTN’s Mission To Improve Drug Abuse Treatment Throughout the Nation… Using SCIENCE as the Vehicle

  4. Uniqueness of CTN • Blending Research and Practice • Bi-directional Collaboration • Multi-node, Multi-site RCTs • Rigorous Scientific Standards • Real World Approach • Dissemination End-products Targeted

  5. CTN Where the Rubber Meets the Road A Paradigm Shift: Transferability, Acceptability, Sustainability

  6. Dissemination New Research Agenda (HIV, CJS, etc.) New Concepts & Protocols (Ongoing) 7 Protocol Projects………12………21………26……… Establish Policies and SOPs Build & Maintain Infrastructure……5…….11………14……….17 FY 2000 FY 2001 FY 2002 FY 2003 CTN Development Update

  7. CTP CTP CTP CTP CTP RRTC CTP CTP CTP CTP CTP National Drug Abuse Treatment Clinical Trials Network Node RRTC – Regional Research and Training Center CTP – Community-Based Treatment Program

  8. Washington Node U. Washington Northern NE Node McLean/Harvard Oregon Node OHSU New England Node Yale Great Lakes Node Wayne State U. New York Node NYU Long Island Node NY State Psych. Inst. California/Arizona Node UCSF/U. Arizona Ohio Valley Node U. Cincinnati Delaware Valley Node U. Pennsylvania Mid-Atlantic Node JHU/MCV Rocky Mountain Node U. Colorado Pacific Node UCLA North Carolina Node Duke Southwest Node U. New Mexico South Carolina Node MUSC Florida Node U. Miami National Drug Abuse Treatment Clinical Trials Network 17 Regional Research and Training Centers working in partnership with 115 Community-Based Treatment Programs across 27 States

  9. Infrastructure

  10. CTN Nodes Northern New England NIDA Director New England New York Delaware Valley Mid-Atlantic Ad Hoc Oversight Oregon Pacific Steering Committee CCTN South Carolina Florida PRB Contract Support Great Lakes Ohio Valley NIDA Grants Management Branch DSMB Rocky Mountain Long Island Repository Washington North Carolina California/ Arizona New Mexico CTN Administrative Overview

  11. Research Portfolio Operations External Affairs Executive Committee Steering Committee

  12. Research Portfolio Operations External Affairs Center for the Clinical Trials Network Administration OD Executive Committee Science Operations Dissemination Steering Committee Data Informatics Review

  13. CTN Rules • CTN Bylaws • CTN Node Performance Index • CTN Operations Guidebook • CTN Study Integrity Monitoring Standards • Medication Trials • Behavioral Trials • CTN Study Safety Monitoring System

  14. Research Concept Generation Network Oversight Board NIDA CTN GO CTN Steering Committee CTN Nodes CTPs Concepts NIDA Director Protocol Development

  15. CTN Protocol Portfolio – 2002

  16. Current CTN Portfolio (21 Protocols) By Intervention Type

  17. Current CTN Portfolio (21 Protocols)Total Projected Enrollment by Intervention Type

  18. Current CTN Portfolio (21 Protocols)Protocols Involving Special Populations

  19. Status of Current Trials:> 1,900 Patients Enrolled

  20. CTN Special Interest Groups • HIV/AIDS • Adolescent • Women and Gender • Co-morbidity • Court-involved Patients • Ethnic Minority • Behavioral Therapy • Buprenorphine • Treatment match • Smoking • Homelessness • Spirituality

  21. CTN Special Interest Group • Generate snapshots of current practice • Identify empirically supported interventions • Develop high quality research concepts • 4 AIDS concepts • 3 Women concepts • 2 Adolescent concepts • 3 Co-morbidity concepts • Identify and develop special research tools • Develop long range research plan • Serve as expert resources

  22. CTN as Research Platform • Currently 4 RO1s from Services Research Branch • Managed by CTN Research Liaison Sub-C • A new PA released from SRB • Bup/NX Post Marketing Survey from Pharmaceutical Co. • Other collaborations welcome

  23. National CTN Symposia: 2003 • 4/03 – AATOD • 5/03 – ASAM, NCDEU • 6/03 – NASADAD, CPDD, RSA • 7/03 – SCT • 8/03 – APsychologicalA • 9/03 – ICTAB-10, Blending Meeting

  24. CTN By-Products • Appreciation of Research/Science in the CTPs • Change of Practice Attitudes • Buprenorphine detox for patients in drug-free clinics • TAU has been greatly modified • Training • GCP/CAB training on regular basis • 80 therapists trained/certified for MI • LIs training in leading complex clinical trials • NIDA’s presence in Community Treatment Programs

  25. CTN Challenges • Gaps Between Researchers and Practitioners • Culture • Interests • Clinical Trials in Real-World Settings • Protocol Design & Analysis • Protocol Implementation

  26. Concept Selection CriteriaResearchers’ perspectives • Need scientific evidence • Need pilot data • Need dose response • Need sample size/power considerations • Need adequate data analysis • Need data to focus future studies • Need assurance of data integrity

  27. Researchers Published in JAMA Replicated Large sample with good power Practitioners Everyone is doing it State mandated It worked for my patients Evidence Criteria How to address bi-directionality issues? How to develop “science-based” practice?

  28. Concept Selection CriteriaPractitioners’ perspectives Need relevance in real life settings • How much internal/external validity? • How representative are the samples? • How does this deviate from practice? • How expensive? Who pays for this? • Any impact on long-term outcome? • Do my patients accept it?

  29. Challenges: Research Design and AnalysisDetermining Control Treatment Pharmacotherapies Placebo control • Ethics • Feasibility Bup/Nx vs. clonidine detox trial • Open trial for feasibility • Patients’/clinicians’ bias uncontrolled

  30. Challenges: Research Design and AnalysisDetermining Control Treatment Behavioral Therapies Standardized control • Relevance for individual sites Treatment-as-usual (TAU) control • Wide variability of TAU between and within sites and over time • Difficulty of analyzing multi-site, multi-TAU data Many trials need to describe and monitor TAUs

  31. User friendly Transferable KISS Protocol language Standardized procedures across sites Quality data output Quality Assurance Implementation Challenges:Accommodating the Real World

  32. Implementation Challenges:Accommodating the Real World • Training • Research experience varies • Fidelity and monitoring • Staff turnover • Assessment batteries • Which instruments? Validated? • How much time? • Redundancy? • Open vs. blinded • Bleeding or contamination

  33. Opportunities A Frontier of Research Researchers and Practitioners are • Fully aware of the challenges • Determined to conquer them • Willing to cooperate

  34. Clinical Trials Network CTN trials completed in 2002: • Buprenorphine/Naloxone Detoxification • Change in programs’ attitudes • Change in medical management of opiate addiction • Adolescent, Dose Tapering trials • Motivational Enhancement Therapy/Motivational Interviewing (MET/MI) • 80 therapists trained/certified • Complement to usual practice • Spanish MET trial

  35. Completed and Ongoing Studies Medication Therapies • Buprenorphine/Naloxone Detoxification • Inpatient/Outpatient Behavioral Therapies • Motivational Enhancement Therapy (MET)/Motivational Interviewing (MI) • Motivational Incentives Therapy • Drug-Free Clinics/Methadone Clinics • TELE Engagement Procedure Surveys • Baseline Survey of CTPs

  36. Studies to Begin Enrollment in 2003 • Bup/Nx Tapering Schedules • Smoking Cessation Treatment in Substance Rehabilitation Programs • Bup/Nx for Adolescents • Infections and Substance Abuse Survey • MET for Pregnant Substance Users • Brief Strategic Family Therapy • Women’s Treatment for Trauma and Substance Use Disorders

  37. Studies Under Development • Patient Feedback • HIV/HCV Risk Reduction Intervention in Drug Treatment Settings • HIV/STD Safer Sex Skills for Men/Women • Job Seekers Training • MET for Spanish Speaking Individuals • HIV Risk Reduction Intervention for Adolescents • Family Management Skills • Community Reinforcement and Family Training • SSRI Treatment of Comorbid Depression and Substance Dependence • Individual 12-Step Facilitation

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