Transcript Behavioral Therapies - CTN Dissemination Library

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
NIDA
NATIONAL INSTITUTE
ON DRUG ABUSE
Institute of Medicine,
1998
Research
Bridging
the
Gap
Practice
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 2010
2009
Council Report
2/3/2010
 Infrastructure
 Research
 Research utilization
 CTN next decade
B. Tai 2010
National Drug Abuse Treatment
Clinical Trials Network
Pacific Northwest
Node
U. Washington
Northern NE Node
McLean/Harvard
Oregon/Hawaii Node
OHSU
New England Node
Yale
New
York
Node
Appalachian
Tri-State NodeNYU
Long Island Node
WPIC/U of Pitt.
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
Pacific Node
UCLA
Southern Consortium
Node
MUSC
Southwest Node
U. New Mexico
Texas Node
UT/S. Med Center
Florida Node
U. Miami
16 RRTCs & 240 CTPs across 37 States and Puerto Rico
B. Tai 2010
National Drug Abuse Treatment
Clinical Trials Network
Regional Research and Training Center (RRTC)
State with Community Treatment Program (CTP)
The Drug Abuse Treatment Community
Hospitals
Kaiser Permanente
VA Hospitals
Mayo Clinic
Mercy Hospital
RWJ Medical Center
Rehab Centers
Betty Ford Center
Hazelden Foundation
Caron Foundation
“Drug free programs”
Odyssey House
Center for Drug-Free Living
Walden House, Phoenix House
Na’Nizhoozi Center
Homeward Bound
Social Model
B. Tai 2010
Methadone Clinics
Evergreen Treatment Services
Addiction Research & Treatment Corp.
Bi-Valley Medical Clinic
Hartford Dispensary
Behavioral Model
Medical Model
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
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
B. Tai 2010
CTN Clinical Coordinating Center
• Provide centralized regulatory
support, trial monitoring, training
in clinical trials implementation
procedures
•
Uniform handling of pharmaceuticals,
laboratory and clinical supplies
Center for the Clinical Trials Network
B. Tai 2010
Council Report
2/3/2010
 Infrastructure
 Research
 Research utilization
 CTN next decade
B. Tai 2010
The CTN Trials (1999-now)
Pending,
Development &
Review
CTN 0022
CTN 0023
CTN 0024
CTN 0025
CTN 0026
CTN 0037
CTN 0044
CTN 0046
CTN 0047
CTN 0048
B. Tai 2010
Data
Collection
CTN 0027
CTN 0031
CTN 0032
Data Analysis
CTN 0014
CTN 0028
CTN 0030
Pharmacotherapies: 12
Behavioral Interventions: 14
HIV/HCV Interventions: 4
Others: 3
Publication &
Dissemination
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
A Decade of
Growth:
CTN by the
(Cumulative)
Numbers
Completed Trials
Randomized Participants
12000
10000
8000
6000
4000
2000
0
Peer-Reviewed Articles
25
120
20
100
15
80
60
10
40
5
20
0
0
B. Tai 2010
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
Highlighting CTN
Pharmacological Therapy Trials
• Buprenorphine (Suboxone)
– CTN 0001, 0002 Bup/Nx vs Clonidine in detox
– CTN 0027 Bup/Nx vs Methadone in maintenance
– CTN 0010 Bup/Nx for adolescents tapering
– CTN 0030 Bup/Nx for 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
CTN Pharmacotherapy Trials
CTN 0010
Context:
Detox only
• Increased heroin
and pharmaceutical opioid
use among 12th graders
• Usual Tx for Opioid addicted youth:
Detox and counseling
Bup/NX 12 weeks
• First RCT study of continued agonist Tx
in this young population
B. Tai 2010
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
MET for Spanish-Speaking Substance Users
CTN 0021
B. Tai 2010
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
CTN 0032: HIV Rapid Testing and
Counseling in Drug Treatment
Recruitment
What is the more
What is the
and
Enrollment
effective testing
more effective
strategy to ensure
testing strategy
Brief
First participant randomized:
01/05/2009
Baseline
they get HIVLast participant Assessment
to reduce their
completed 12/31/2009
tested and receive
risk behaviors?
Random Assignment
their results?Total Participants
Randomized: 1281
Offer Rapid Testing
with RESPECT
Counseling
Offer Rapid Testing
with Minimal
Counseling
Client post-intervention
data collection
B. Tai 2010
-
Offer Referral for
Testing in Community
CTN American Indian
Collaborations
Node initiated exploratory studies
to develop collaborations with
tribes and Native American
treatment programs to explore
methamphetamine use and cooccurring problems:
Southwest Node
Ohio Valley Node
Pacific Northwest Node
Oregon Hawaii Node
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
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
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
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
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
B. Tai 2010
Hein et al AJP Jan 2010, 167, 1, 95-101
Providing Implications for
Practice
B. Tai 2010
Back, SE Am J Psychiatry 167:1, January 2010
B. Tai 2010
Severity
3.00
0.20
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0.00
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-2.80
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Probably of Endorsement
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1.00
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0.00
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-0.40
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-2.60
-2.80
-3.00
Probably of Endorsement
Figure 1
Alcohol -- Item Characteristic Curves
1.20
1.00
0.80
Tolerance
Withdrawal
Larger Amounts
Cut Down
Time Spent
Giving Up
0.00
Continued Use
Severity
Marijuana -- Item Characteristic Curves
1.20
1.00
0.80
Tolerance
Withdrawal
Larger Amounts
Cut Down
Time Spent
Giving Up
0.00
Continued Use
Council Report
2/3/2010
 Infrastructure
 Research
 Research utilization
 CTN next decade
B. Tai 2010
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
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
The CTN Dissemination Library
http://ctndisseminationlibrary.org
•
•
•
Housed and maintained by Washington Node
Inaugural year 2003
Library usage statistics
B. Tai 2010
YEAR
Visitors
Documents
requested
Publications
added
2009
11,592
344
39
2008
10,489
77
36
2007
8,644
19
33
2006
4,459
17
18
2005
1,003
NA
2
NIDA-SAMHSA Blending Products
www.attcnetwork.org/explore/priorityareas/science/blendinginitiative/index.asp
Promoting Awareness of
Motivational Incentives (PAMI)
Buprenorphine
Treatment: A
Training for
Multidisciplinary
Addiction
Professionals
B. Tai 2010
Short-Term
Opioid
Withdrawal
Using
Buprenorphine
Treatment
Planning
MATRS: Utilizing
the Addiction
Severity Index
(ASI) to Make
Required Data
Collection Useful
Motivational
Interviewing
Assessment:
Supervisory
Tools for
Enhancing
Proficiency
(MIA-STEP)
Promoting
Awareness of
Motivational
Incentives
(PAMI)
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:
–
–
–
–
B. Tai 2010
Data sets (SAS and ASCII)
Defined file (aka data dictionary)
Annotated Case Report Forms
Study protocol and reference to study publication of
primary outcomes
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
Council Report
2/3/2010
 Infrastructure
 Research
 Research utilization
 CTN next decade
B. Tai 2010
CTN RFA 2009
•
•
•
•
•
B. Tai 2010
Published – June 2009
Proposals – November 2009
Review – February 2010
Council – May 2010
Award – September 2010
Stay Tuned…
Future of the CTN
Mission/Goals
• 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
B. Tai 2010
Future of the CTN
Infrastructures
• Current
• Future expansion
ED
CTP
CTP
CTP
CTP
CTP
CTP
Dental
HMO
RRTC
PCP
CTP
RRTC
HIV
CTP
CTP
CTP
Optimal ratio of research $/infrastructure $
B. Tai 2010
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 2010
2009
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 2010
2009
Future of the CTN
Ask 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
• “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?
B. Tai 2010
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 2010
2009
www.nida.nih.gov/CTN/Index.htm
B. Tai 2009
Q&A
B. Tai 2010