Transcript National and State Research: The Clinical Trials Network

What the Heck is the CTN Anyway?
The NIDA National Drug Abuse
Treatment Clinical Trials Network
Principles of
Drug Addiction
Treatment
Counseling and Other
Behavioral Therapies
Are Critical Components
of Effective Treatment
For Addiction
Principles of
Drug Addiction
Treatment
Medications Are An
Important Element
of Treatment For
Many Individuals,
Especially When
Combined With
Behavioral Therapies
Institute of Medicine Report
Bridging the Gap
between
Practice and Research:
Forging Partnerships
with
Community-Based Treatment
Lamb, Greenlick, McCarty, 1998
Practice & Policy
Science
We Need To Bring
Practice and Policy In Line
With the Science
Practice & Policy
Bridging the Gap
Research
Practice
Policy
How Can We Accomplish This?
CSAT’s Response to IOM Report:
Practice Improvement Collaboratives
• Developed in 1999, with 7 statewide and 7 metropolitan
area projects
• To support and promote effective and efficient communitybased treatment
• Develop and sustain community involvement in and
commitment to practice improvement in the delivery of
substance abuse treatment services
• Improve the quality of substance abuse treatment through
the adoption of evidence-based practices in communitybased organizations
NIDA’s Response to the IOM Report
The National Drug Abuse Treatment
Clinical Trials Network
(CTN)
NIDA’s Millennial Goal:
To Improve Drug Abuse Treatment
Throughout the Nation…
Using SCIENCE as the Vehicle
NIDA Treatment Initiative
Develop New Treatment Components
Improve Existing Treatment Components
Incorporate Efficacious Treatments into
Clinical Practice
NIDA’s Clinical Trials Network
• Established in 1999.
• NIDA’s largest initiative to blend research
and clinical practice by bringing promising
therapies to community treatment providers.
• Network of 17 University-based Nodes
(RRTCs) involving 116 Community
Treatment Programs (CTPs) in 24 states,
Washington D.C. and Puerto Rico.
Important Precursors to CTN
at the Local Level
•
•
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•
DASA Research Subcommittee
ADAI Statewide Outcome Project
Failed attempt for NIDA center grant
Decision not to try for CTN the first time
around
• DASA “Bridging the Gap” Group
DASA “Bridging the Gap” Group
• Developed as an offshoot from the DASA
Research Subcommittee
• Stimulated by Institute of Medicine’s 1998 report,
“Bridging the Gap Between Practice and
Research: Forging Partnerships with CommunityBased Drug and Alcohol Treatment”
• Brought together individuals with interest in
research and practice, and expanded to include
“policy” as a component
Bridging the Gap Group
• Helped plan the November 1999 NIDA Town Meeting in
Seattle, including a panel entitled “Bridging the Gaps:
Policy – Practice – Research”
• Helped develop subsequent DASA Research Meetings
• Provided a sounding board in the development of the
Washington grant proposal submitted for the CTN
• Provided clear evidence that there was a supportive
atmosphere for researchers, community-based
practitioners, and policy implementers to work together
collaboratively
National Drug Abuse Treatment
Clinical Trials Network
CTN Nodes
Washington Node
U. Washington
Northern NE Node
McLean/Harvard
Oregon Node
OHSU
Great Lakes Node
Wayne State U.
California/Arizona Node
UCSF/U. Arizona
Ohio Valley Node
U. Cincinnati
Rocky Mountain Node
U. Colorado
Pacific Node
UCLA
New England Node
Yale
New York Node
NYU
Long Island Node
NY State Psych. Inst
Delaware Valley Node
U. Pennsylvania
Mid-Atlantic Node
JHU/MCV
North Carolina Node
Duke
Southwest Node
U. New Mexico
South Carolina Node
MUSC
Florida Node
U. Miami
National Drug Abuse Treatment
Clinical Trials Network
Goal: To establish a research infrastructure to improve
the quality of drug abuse treatment in the nation
 Conduct multi-site clinical trials of interventions
efficacious in small-scale studies, to test their effectiveness
across a broad range of clinical settings and patient
populations.
 Develop models for integrating new medications and
behavioral interventions into clinical practice.
Purpose of the National Drug Abuse
Clinical Trials Network
“…do these treatments work when you embed them in
diverse, ongoing treatment programs and do they work
with diverse patients typically seen in community-based
treatment programs? The second goal of the network is
to diffuse those science-based treatment components that
are in fact shown to be effective into ongoing practice
throughout the country.”
Alan Leshner, Ph.D.
Director, National Institute on Drug Abuse
National Drug Abuse Clinical Trials Network
Kickoff Meeting (2/99)
Moving from Research to Community
Based Treatment
It’s as Much a Process as It Is an Outcome
Basic Operating Principle of the CTN
Research
Practice
Bidirectional Partnership
A CTP View of the
Research-to-Practice Process
“Research to practice is like marriage; if you
stick together with anything long enough
you can get used to it and develop a unique
affection.”
Nancy Hamilton, M.P.A., CAP, CCJAP, Operation PAR, Florida Node
National Drug Abuse Treatment
Clinical Trials Network Node
CTP
CTP
CTP
CTP
CTP
RRTC
CTP
CTP
CTP
CTP
CTP
RRTC -- Regional Research and Training Center
CTP -- Community-Based Treatment Program
Regional Research and Training Centers
(RRTCs)
A Center Core
• Research agenda, management plan, SOPs,
policies, budget, training, performance
measures
A Data Management Center
• Statistical support, methods/design, data
management
Community Based Treatment Programs (CTPs)
• Operational plan, concept generation, protocol
implementation, subject accrual, QA
Regional Research and Training Centers
(RRTCs)
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•
•
•
•
Initiate and Develop Protocols
Conduct Studies
Arrange CTP Participation
Design and Conduct Training
Implement Local Data Management Plan
Additional Components of
Washington Node RTC
• CTN Dissemination Library
• Dissemination Specialist / ATTC Liaison
Community Treatment Programs
(CTPs)
•
•
•
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Provide Setting for CTN Studies
Incorporate CTN Training Protocols
Collect Protocol-Specific Data
Generate Clinically Relevant Concepts
Have equal representation on CTN Steering
Committee
• Participate fully in CTN committees
National Drug Abuse Treatment
Clinical Trials Network – Washington Node
The Washington Node
CTP
CTP
RCKC
Residence XII
CTP
Providence
CTP
Kitsap Recovery
Research Center
CTP
Evergreen Manor
University of
Washington
CTP
Vancouver
VAMC
CTP
Triumph
CTP
Evergreen
Treatment
The Washington Node of the
NIDA Clinical Trials Network
The Route from Concept to
Protocol Implementation
Concept
Development
Concept
Review
Community Clinicians
and
Researchers
Protocol
Development
Protocol
Review
Protocol
Implementation
in CTPs
Protocol Design & Implementation
Protocol Development
Design and Analysis
Project
Teams
Data Management
Regulatory
Training
Quality Assurance
Publications
Steering
Committee
“NIDA Clinical Trials Network
Begins First Multisite Tests
of
New Science-Based Drug Abuse
Treatments”
By Robert Mathias, NIDA NOTES Staff Writer
NIDA Notes - Volume 15, Number 6
First CTN Protocols
Buprenorphine / Naloxone Detoxification
*
Motivational Enhancement Therapy (MET)
to Improve Treatment Engagement
 Motivational Incentive – Vouchers for
Drug Free Urine Samples
CTN Protocols
• A baseline assessment of the CTN for investigating diffusion of
innovation *
• Smoking cessation
• Buprenorphine/naloxone-facilitated rehabilitation of heroin addicted
adolescents
• Telephone-enhanced long-term engagement
• Infections and Substance abuse *
• MET for pregnant substance abusers
• Brief strategic family therapy for adolescent drug abusers
• Women's treatment for trauma and substance use disorders *
CTN Protocols
• Patient feedback improvement system
• HIV intervention in drug treatment settings *
• HIV/STD safer sex skills for men **
• HIV/STD safer sex skills for women *
• Job seekers workshop
• MET – Spanish
• Family management skills for opiate addicted women
• 12-step facilitation **
• Reducing HIV risk among adolescent drug abusers
• Community reinforcement and family training for increasing
motivation
• Treatment of depressed adult substance abusers (Lexapro)
Local CTN Involvement
• Buprenorphine Detoxification Taper
– Providence Behavioral Health
– Andy Saxon, Anthony Floyd
• Women’s Treatment for Trauma and Substance
Use Disorders
– Residence XII
– Betsy Wells, Mary Hatch Maillette
• HIV Intervention in Drug Treatment Settings
– Recovery Centers of King County
– Don Calsyn, Anthony Floyd
Local CTN Involvement
• HIV Safer Sex Skills for Men and Women
– Evergreen Treatment Services
– Don Calsyn, Sara Berns, Mary Hatch-Maillette
• Twelve Step Facilitation
– Under Development
– Dennis Donovan