National Drug Abuse Treatment Clinical Trials Network

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National Drug Abuse TreatmentClinical Trials
Network
February 13, 2003 Betty Tai, Ph.D. Director,
Center for the Clinical Trials Network, NIDA/NIH
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Who could want a more lovely way To spend
Valentines Day Than talking about how we
may Implement protocols the CTN way
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CTNs Mission
To Improve Drug Abuse Treatment Throughout the
Nation Using SCIENCE as the Vehicle
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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

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CTN
Where the Rubber Meets the Road
A Paradigm Shift Transferability, Acceptability,
Sustainability
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CTN Development Update
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National Drug Abuse Treatment Clinical Trials
Network Node
RRTC Regional Research and Training Center CTP
Community-Based Treatment Program
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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
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Infrastructure
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CTN Administrative Overview
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Research Portfolio
Operations
External Affairs
Executive Committee
Steering Committee
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Data Informatics
Review
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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

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Protocol Development
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CTN Protocol Portfolio 2002
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Current CTN Portfolio (21 Protocols) By
Intervention Type
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Current CTN Portfolio (21 Protocols)Total
Projected Enrollment by Intervention Type
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Current CTN Portfolio (21 Protocols)Protocols
Involving Special Populations
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Status of Current Trialsgt 1,900 Patients
Enrolled
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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

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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

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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

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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

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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
• NIDAs presence in Community Treatment Programs

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CTN Challenges

• Gaps Between Researchers
• and Practitioners
• Culture
• Interests
• Clinical Trials in Real-World Settings
• Protocol Design Analysis
• Protocol Implementation

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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

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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?
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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?

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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

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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

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Implementation ChallengesAccommodating the Real
World

• User friendly
• Transferable
• KISS
• Protocol language
• Standardized procedures across sites
• Quality data output
• Quality Assurance

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Implementation ChallengesAccommodating 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

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Opportunities

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

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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

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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

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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
• Womens Treatment for Trauma and Substance Use
  Disorders

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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