National Drug Abuse Treatment Clinical Trials Network
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Transcript of National Drug Abuse Treatment Clinical Trials Network
National Drug Abuse TreatmentClinical Trials Network
February 13, 2003Betty 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
To Improve Drug Abuse TreatmentThroughout the Nation…
Using SCIENCE as the Vehicle
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
CTNWhere the Rubber Meets the Road
A Paradigm Shift: Transferability, Acceptability, Sustainability
CTN Development Update
FY 2000 FY 2001 FY 2003FY 2002
7 Protocol Projects………12………21………26………
Dissemination
New Research Agenda (HIV, CJS, etc.)
New Concepts & Protocols (Ongoing)
Build & Maintain Infrastructure……5…….11………14……….17
Establish Policies and SOPs
National Drug Abuse Treatment Clinical Trials Network Node
RRTC – Regional Research and Training CenterCTP – Community-Based Treatment Program
CTPCTP
CTP
CTP
CTPCTP
CTP
CTP
CTP
CTP
RRTC
National Drug Abuse Treatment Clinical Trials Network
Oregon NodeOregon NodeOHSUOHSU
Washington NodeWashington NodeU. WashingtonU. Washington
Pacific NodePacific NodeUCLAUCLA
Rocky Mountain NodeRocky Mountain NodeU. ColoradoU. Colorado
Florida NodeFlorida NodeU. MiamiU. Miami
Great Lakes NodeGreat Lakes NodeWayne State U.Wayne State U.
Ohio Valley NodeOhio Valley NodeU. CincinnatiU. Cincinnati
South Carolina NodeSouth Carolina NodeMUSCMUSC
North Carolina NodeNorth Carolina NodeDukeDuke
California/Arizona NodeCalifornia/Arizona NodeUCSF/U. ArizonaUCSF/U. Arizona
Southwest NodeSouthwest NodeU. New MexicoU. New Mexico
Northern NE NodeNorthern NE NodeMcLean/HarvardMcLean/Harvard
New England NodeNew England NodeYaleYaleNew York NodeNew York Node
NYUNYULong Island NodeLong Island Node
NY State Psych. Inst.NY State Psych. Inst.
Delaware Valley NodeDelaware Valley NodeU. PennsylvaniaU. Pennsylvania
Mid-Atlantic NodeMid-Atlantic NodeJHU/MCVJHU/MCV
17 Regional Research and Training Centers17 Regional Research and Training Centers working in partnership with working in partnership with 115 Community-Based 115 Community-Based
Treatment ProgramsTreatment Programs across across 27 States27 States
Infrastructure
CTN Administrative Overview
NIDA GrantsManagement
Branch
Ad HocOversight
PRB
DSMB
CCTN
ContractSupport
CTN Nodes
Repository
Steering Committee
NIDA Director New England New York
Delaware Valley Mid-Atlantic
Oregon Pacific
South Carolina Florida
Great Lakes Ohio Valley
RockyMountain Long Island
Washington NorthCarolina
California/Arizona New Mexico
NorthernNew England
Steering Committee
Research Portfolio Operations External Affairs
Executive Committee
AdministrationOD
Science Operations Dissemination
Center for the Clinical Trials Network
Steering Committee
Research Portfolio Operations External Affairs
Executive Committee
ReviewData
Informatics
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
Research Concept Generation
NIDA CTN
CTN Steering
Committee
Network Oversight Board
NIDA Director
Concepts
CTN Nodes
CTPs
ProtocolDevelopment
CTN Protocol Portfolio – 2002Project # Protocol Title LI
CTN 0001 Bup/Nal vs Clonidine for Inpatient Opiate Detox LingCTN 0002 Bup/Nal vs Clonidine for Outpatient Opiate Detox LingCTN 0003 Bup/Nal: Comparison of Three Taper Schedules for Opiate Detox Amass
CTN 0004 MET (Motivational Enhancement Treatment) To Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse Carroll
CTN 0005 MI (Motivational Interviewing) To Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse Carroll
CTN 0006 Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics StitzerCTN 0007 Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics StitzerCTN 0008 Baseline Survey Greenlick
CTN 0009 Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy in Substance Abuse Rehabilitation Program Reid
CTN 0010 Bup/Nal in the Treatment of Adolescent and Young Adult Heroin Addicts WoodyCTN 0011 Telephone Enhancement of Long-Term Engagement HubbardCTN 0012 Infections Screening in Substance Abuse Treatment Programs BrownCTN 0013 Motivational Interviewing for Pregnant Women Seeking Substance Abuse Treatment WinhusenCTN 0014 Brief Strategic Family Therapy for Adolescent Drug Abusers Szapocznik
CTN 0015 Women’s Treatment for Substance Use Disorders and Trauma in Inpatient Rehabilitation and Intensive Outpatient Settings Hien
CTN 0016 Patient Feedback: A Performance Improvement Study FormanCTN 0017 HIV/HCV Intervention in Drug Treatment Settings BoothCTN 0018 HIV/STD Safer Sex Skills Groups for Men CalsynCTN 0019 HIV/STD Safer Sex Skills Groups for Women TrossCTN 0020 Job Seekers Training for Clients with Drug Dependence SvikisCTN 0021 MET or MI: Spanish version Carroll
Current CTN Portfolio (21 Protocols) By Intervention Type
Medication (5)
Services/Non-treatment (5)
MET/MI (4)
HIV (3)
Incentives (2)
CBT (1)
Family (1)
Current CTN Portfolio (21 Protocols)Total Projected Enrollment by Intervention Type
Medication n=2400
HIV Behavioral n=1500
Non-HIV Behavioral
n=4900
Current CTN Portfolio (21 Protocols)Protocols Involving Special Populations
No Special Population (15)
Women (3)
Adolescents (2)
Spanish Speakers (1)
Status of Current Trials:> 1,900 Patients Enrolled
ProtocolNIDA-CTN- Short Title Number
RandomizedEnrollment
Target
0001 Bup/Nx Inpatient 113 Closed
0002 Bup/Nx Outpatient 233 Closed
0004 MET 349 600
0005 MI 400 Closed
0006 Incentives Drug-Free 410 400
0007 Incentives Methadone 391 400
0011 TELE 13 360
CTN Special Interest Groups1. HIV/AIDS2. Adolescent3. Women and Gender4. Co-morbidity5. Court-involved Patients6. Ethnic Minority7. Behavioral Therapy8. Buprenorphine 9. Treatment match 10. Smoking11. Homelessness12. Spirituality
1. Generate snapshots of current practice 2. Identify empirically supported interventions3. Develop high quality research concepts
4 AIDS concepts 3 Women concepts 2 Adolescent concepts 3 Co-morbidity concepts
4. Identify and develop special research tools5. Develop long range research plan 6. Serve as expert resources
CTN Special Interest Group
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
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
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
CTN Challenges
• Gaps Between Researchers and Practitioners– Culture– Interests
• Clinical Trials in Real-World Settings– Protocol Design & Analysis– Protocol Implementation
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
Evidence Criteria
• Researchers– Published in JAMA– Replicated– Large sample with
good power
• Practitioners– Everyone is doing it– State mandated– It worked for my
patients
How to address bi-directionality issues?
How to develop “science-based” practice?
Concept Selection CriteriaPractitioners’ perspectives
Need relevance in real life settings1. How much internal/external validity?2. How representative are the samples?3. How does this deviate from practice?4. How expensive? Who pays for this? 5. Any impact on long-term outcome?6. Do my patients accept it?
Challenges: Research Design and AnalysisDetermining Control Treatment
Placebo control • Ethics • Feasibility
Bup/Nx vs. clonidine detox trial• Open trial for feasibility • Patients’/clinicians’ bias uncontrolled
Pharmacotherapies
Challenges: Research Design and AnalysisDetermining Control Treatment
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
dataMany trials need to describe and monitor TAUs
Behavioral Therapies
Implementation Challenges:Accommodating the Real World
• User friendly• Transferable• KISS • Protocol language• Standardized procedures across sites
– Quality data output– Quality Assurance
• Training– Research experience varies– Fidelity and monitoring– Staff turnover
• Assessment batteries– Which instruments? Validated? – How much time?– Redundancy?
• Open vs. blinded– Bleeding or contamination
Implementation Challenges:Accommodating the Real World
Opportunities
A Frontier of Research
Researchers and Practitioners are • Fully aware of the challenges • Determined to conquer them• Willing to cooperate
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
Clinical Trials Network
Completed and Ongoing StudiesMedication 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
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
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