Betty Tai, Ph.D. Betty Tai, Ph.D. February 3, 2010 February 3, 2010 Director Director Center for the Clinical Trials Network Center for the Clinical Trials Network National Institute on Drug Abuse National Institute on Drug Abuse NATIONAL INSTITUTE ON DRUG ABUSE NIDA NIDA Drug Abuse Treatment Clinical NIDA Drug Abuse Treatment Clinical Trials Network Trials Network The First Decade The First Decade
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Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network
NIDA. NATIONAL INSTITUTE ON DRUG ABUSE. 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. Institute of Medicine, 1998. NIDA Clinical Trials Network. - PowerPoint PPT Presentation
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Betty Tai, Ph.D.Betty Tai, Ph.D.February 3, 2010 February 3, 2010
DirectorDirector
Center for the Clinical Trials NetworkCenter for the Clinical Trials Network
National Institute on Drug AbuseNational Institute on Drug Abuse
NATIONAL INSTITUTEON DRUG ABUSE
NIDA
NIDA Drug Abuse Treatment Clinical Trials NetworkNIDA Drug Abuse Treatment Clinical Trials NetworkThe First DecadeThe First Decade
Research Practice
Research Practice
BridgingtheGap
BridgingtheGap
Institute of Medicine,Institute of Medicine,19981998
Institute of Medicine,Institute of Medicine,19981998
CTN PremisesCTN PremisesCTN PremisesCTN 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.
• 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 B. Tai 20092009B. Tai B. Tai 20102010
Council Report2/3/2010
Council Report2/3/2010
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
B. Tai B. Tai 20102010
National Drug Abuse Treatment National Drug Abuse Treatment Clinical Trials NetworkClinical Trials Network
Oregon/Hawaii NodeOregon/Hawaii NodeOHSUOHSU
Pacific NorthwestPacific Northwest NodeNode
U. WashingtonU. Washington
Pacific NodePacific NodeUCLAUCLA
Texas NodeTexas NodeUT/S. Med CenterUT/S. Med Center
Southwest NodeSouthwest NodeU. New MexicoU. New Mexico
Northern NE NodeNorthern NE NodeMcLean/HarvardMcLean/Harvard
New England NodeNew England NodeYaleYale
New York NodeNew York NodeNYUNYU
Long Island NodeLong Island NodeNY State Psych. Inst.NY State Psych. Inst.
Delaware Valley NodeDelaware Valley NodeU. PennsylvaniaU. Pennsylvania
Mid-Atlantic NodeMid-Atlantic NodeJHU/MCVJHU/MCV
16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto RicoB. Tai B. Tai 20102010
National Drug Abuse Treatment National Drug Abuse Treatment Clinical Trials NetworkClinical Trials Network
Regional Research and Training Center (RRTC) State with Community Treatment Program (CTP)
The Drug Abuse Treatment CommunityThe Drug Abuse Treatment Community
Rehab Centers
Betty Ford CenterHazelden Foundation
Caron Foundation
Social Model Behavioral Model Medical Model
HospitalsKaiser Permanente
VA HospitalsMayo Clinic
Mercy HospitalRWJ Medical Center
“Drug free programs”Odyssey House
Center for Drug-Free LivingWalden House, Phoenix House
Na’Nizhoozi CenterHomeward Bound
Methadone ClinicsEvergreen Treatment Services
Addiction Research & Treatment Corp.Bi-Valley Medical Clinic
Hartford Dispensary
B. Tai B. Tai 20102010
CTN Coordinating Centers
Organizational design of a multisite trial is as Organizational design of a multisite trial is as important to its success as is the experimental important to its success as is the experimental design. design.
““Science and process are equally important to Science and process are equally important to ensure success of large prospective studiesensure success of large prospective studies
Timothy Sprosen, UK BiobankTimothy Sprosen, UK BiobankNIH New Models for Large Prospective Studies symposium (1/22/2010) NIH New Models for Large Prospective Studies symposium (1/22/2010)
CTN Coordinating Centers
CTN Data and Statistics CentersCTN Data and Statistics Centers
• Provide statistical support for Provide statistical support for protocol design/analysis protocol design/analysis
• Provide data management via Provide data management via electronic data captureelectronic data capture
• Monitor integrity and security of dataMonitor integrity and security of data
CTN Clinical Coordinating Center• Provide centralized regulatory support, trial monitoring, training in clinical trials implementation
procedures
• Uniform handling of pharmaceuticals, laboratory and clinical supplies
B. Tai B. Tai 20102010
B. Tai B. Tai 20102010
Council Report2/3/2010
Council Report2/3/2010
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
B. Tai B. Tai 20102010
Pending, Pending, Development & Development &
ReviewReview
Pending, Pending, Development & Development &
ReviewReview
Data Data CollectionCollection
Data Data CollectionCollection Data AnalysisData AnalysisData AnalysisData Analysis Publication & Publication &
A Decade of A Decade of Growth: Growth: CTN by the CTN by the (Cumulative) (Cumulative) NumbersNumbers
B. Tai B. Tai 20102010
CTN Studies in DevelopmentCTN Studies in Development
• STRIDE (CTN 0037):STRIDE (CTN 0037):– Stimulant Reduction Intervention Using Dosed Exercise Stimulant Reduction Intervention Using Dosed Exercise
• Web-delivery of Evidence-Based, Psychosocial Treatment Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders (CTN 0044) for Substance Use Disorders (CTN 0044)
• S-CAST (CTN 0046) S-CAST (CTN 0046) – Smoking Cessation and Stimulant TreatmentSmoking Cessation and Stimulant Treatment
• SMART-ED (CTN 0047)SMART-ED (CTN 0047)– Screening, Motivational Assessment, Referral and Treatment in Screening, Motivational Assessment, Referral and Treatment in
Emergency DepartmentsEmergency Departments
• CURB (CTN 0048)CURB (CTN 0048)– Cocaine Use Reduction with BuprenorphineCocaine Use Reduction with Buprenorphine
• 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 B. Tai 20092009
MET for Spanish-Speaking Substance UsersCTN 0021
B. Tai B. Tai 20102010
Study Challenges and Opportunities Study Challenges and Opportunities CTN 0021CTN 0021
• Recruited 436 representative population of US Recruited 436 representative population of US Hispanics across 5 CTP sites Hispanics across 5 CTP sites
• Bilingual investigators/therapists/RAs Bilingual investigators/therapists/RAs • Translation of 70% of project materialsTranslation of 70% of project materials
• Bilingual Training and fidelity monitoring Bilingual Training and fidelity monitoring
• Shovel ready project for Spanish language Shovel ready project for Spanish language international collaborationinternational collaboration
B. Tai B. Tai 20102010
CTN 0032: HIV Rapid Testing and Counseling in Drug Treatment
CTN 0032: HIV Rapid Testing and Counseling in Drug Treatment
Recruitment and
Enrollment
Brief Baseline
Assessment
-
Offer Rapid Testing with RESPECT
Counseling
Random Assignment
Client post-intervention data collection
Offer Rapid Testing with Minimal Counseling
Offer Referral for Testing in Community
What is the more effective testing strategy to ensure they get HIV tested and receive their results?
What is the more effective testing strategy to ensure they get HIV tested and receive their results?
What is the more effective testing strategy to reduce their risk behaviors?
What is the more effective testing strategy to reduce their risk behaviors?
First participant randomized: 01/05/2009 Last participant completed 12/31/2009
Total Participants Randomized: 1281
B. Tai B. Tai 20102010
Node initiated exploratory studies to develop collaborations with tribes and Native American treatment programs to explore methamphetamine use and co-occurring problems:
Southwest NodeOhio Valley NodePacific Northwest NodeOregon Hawaii Node
• 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 B. Tai 20102010
CTN Ancillary Studies CTN 0031: STAGE-12
• CTN 0031 A-1CTN 0031 A-1– Identify the association between performance and Identify the association between performance and
neurotoxic oxidative stress level neurotoxic oxidative stress level (by measuring antioxidants (by measuring antioxidants parameters in the plasma) parameters in the plasma)
• CTN 0031 A-2CTN 0031 A-2 – Validate the concept that Validate the concept that frequency of risk drinking patternsfrequency of risk drinking patterns
a predictor for severity of AUDs in a clinical populationa predictor for severity of AUDs in a clinical population
• CTN 0031 A-3CTN 0031 A-3 – Identify Identify organizational and counselor level organizational and counselor level factors that may factors that may
impact the implementation process and possible adoption of impact the implementation process and possible adoption of STAGE-12STAGE-12
– Mediators and moderators and their interactions at baselineMediators and moderators and their interactions at baseline
• Scientist RationaleScientist Rationale– Investigators (especially junior) benefitInvestigators (especially junior) benefit– A platform for independent research supportA platform for independent research support– Training opportunities (e.g., K Awards)Training opportunities (e.g., K Awards)
• Economic RationaleEconomic Rationale– Inexpensive methods to address important questions Inexpensive methods to address important questions – More precisely define future research steps More precisely define future research steps – Shorten measures to save future costsShorten measures to save future costs
– Mediators and moderators and their interactions at baselineMediators and moderators and their interactions at baseline
• Scientist RationaleScientist Rationale– Investigators (especially junior) benefitInvestigators (especially junior) benefit– A platform for independent research supportA platform for independent research support– Training opportunities (e.g., K Awards)Training opportunities (e.g., K Awards)
• Economic RationaleEconomic Rationale– Inexpensive methods to address important questions Inexpensive methods to address important questions – More precisely define future research steps More precisely define future research steps – Shorten measures to save future costsShorten measures to save future costs
B. Tai B. Tai 20102010
Do Treatment Improvements in PTSD Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? Severity Affect Substance Use Outcomes? A A Secondary Analysis Secondary Analysis From a Randomized From a Randomized Clinical Trial in NIDA’s Clinical Trials Clinical Trial in NIDA’s Clinical Trials NetworkNetwork
Denise A. Hien et al.Denise A. Hien et al.American Journal of PsychiatryAmerican Journal of PsychiatryJanuary 2010, Vol. 167, No. 1, 95-101 January 2010, Vol. 167, No. 1, 95-101
B. Tai B. Tai 20102010
Conclusions/ImplicationsConclusions/Implications
• PTSD severity reductions were associated with SUD PTSD severity reductions were associated with SUD improvement improvement
• Integrated PTSD/SUD treatments may be Integrated PTSD/SUD treatments may be advantageous for patients with severe symptomsadvantageous for patients with severe symptoms
• For further study:For further study:
– Men, mixed populationsMen, mixed populations
– Combat/military traumaCombat/military trauma
– Other forms of integrated treatmentOther forms of integrated treatment
Hein et al AJP Jan 2010, 167, 1, 95-101 AJP Jan 2010, 167, 1, 95-101 B. Tai B. Tai 20102010
Providing Implications for Providing Implications for PracticePractice
Back, SE Am J Psychiatry 167:1, January 2010B. Tai B. Tai 20102010
Alcohol -- Item Characteristic Curves
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Figure 1
Marijuana -- Item Characteristic Curves
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B. Tai B. Tai 20102010
Council ReportCouncil Report2/3/20102/3/2010
Council ReportCouncil Report2/3/20102/3/2010
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
InfrastructureInfrastructure
ResearchResearch
Research utilizationResearch utilization
CTN next decadeCTN next decade
B. Tai B. Tai 20102010
Research Utilization Research Utilization
Process through which research findings are put in use in the form of programs and policies
Process through which research findings are put in use in the form of programs and policies
• DifficultDifficult
• SlowSlow
• Not an action that begins when research is Not an action that begins when research is completedcompleted
• Rather a two way concurrent processRather a two way concurrent process
Everett Rogers, Everett Rogers, Diffusion of InnovationsDiffusion of Innovations, 2003, 2003
CTN Research Utilization ActivitiesCTN Research Utilization Activities
• Led by CTN Research Utilization CommitteeLed by CTN Research Utilization Committee
• Coordinate intra-CTN and intra-Node activitiesCoordinate intra-CTN and intra-Node activities
• Support and monitor the CTN dissemination library Support and monitor the CTN dissemination library utilizationutilization
• Serve as point of contact for Serve as point of contact for – NIDA Blending ConferenceNIDA Blending Conference
– SAMHSA ATTC ProgramSAMHSA ATTC Program
• Major regional workshops in 2009Major regional workshops in 2009– June 2009 Pacific Region (Portland, Oregon)June 2009 Pacific Region (Portland, Oregon)
Promoting Awareness of Motivational Incentives (PAMI)
TreatmentTreatmentPlanningPlanningMATRS: Utilizing MATRS: Utilizing the Addiction the Addiction Severity Index Severity Index (ASI) to Make (ASI) to Make Required Data Required Data Collection UsefulCollection Useful
B. Tai B. Tai 20102010
• CDISC standardized
• HIPAA Compliant
• CTN Public data/documents include:– Data sets (SAS and ASCII)
– Defined file (aka data dictionary)
– Annotated Case Report Forms – Study protocol and reference to study publication of
primary outcomes
CTN Data Sharinghttp://www.ctndatashare.orgCTN Data Sharinghttp://www.ctndatashare.org
International Outreach: International Outreach: NIDA CTN INVEST FellowsNIDA CTN INVEST Fellows
• Create an international network of scientistsCreate an international network of scientists• CTN serves as the training platformCTN serves as the training platform• Senior non-U.S. scientists and health administratorsSenior non-U.S. scientists and health administrators
– 2007 (1), 2008 (3), 2009 (2) and 2010 (3)2007 (1), 2008 (3), 2009 (2) and 2010 (3)– Export CTN technology, identified future opportunities for Export CTN technology, identified future opportunities for
collaboration and fundingcollaboration and funding
• Proposals – November 2009 Proposals – November 2009
• Review – February 2010Review – February 2010
• Council – May 2010Council – May 2010
• Award – September 2010Award – September 2010
CTN RFA 2009CTN RFA 2009
Stay Tuned…
B. Tai B. Tai 20102010
Future of the CTNFuture of the CTNMission/GoalsMission/Goals
• Bring drug abuse treatment into mainstream medical Bring drug abuse treatment into mainstream medical practicepractice– Engage providers from medical settingsEngage providers from medical settings
• Flexible research strategy/portfolioFlexible research strategy/portfolio– Seize new scientific opportunitiesSeize new scientific opportunities
– Address emerging public health concernsAddress emerging public health concerns
• Training platform for clinical workforceTraining platform for clinical workforce
• Facilitate research utilizationFacilitate research utilization
B. Tai B. Tai 20102010
• Current
RRTC
CTP
CTP
CTP
CTP
CTP
Future of the CTNInfrastructures
• Future expansion
RRTC
Dental
HIV
ED
HMO
CTP
CTP
CTP
CTP
CTP
ED
HIV
CTP
PCP
B. Tai B. Tai 20102010
Optimal ratio of research $/infrastructure $ Optimal ratio of research $/infrastructure $
Future of the CTN Challenges and Opportunities
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
• 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 B. Tai 20092009B. Tai B. Tai 20102010
Future of the CTN Challenges and Opportunities
Future of the CTN Challenges and Opportunities
• New statistical tools and techniques– adaptive design – simulation and modeling – large database mining
• Chronic Disease management model– treatment algorithm for continuing care
B. Tai B. Tai 20092009B. Tai B. Tai 20102010
Future of the CTNAsk a different research question
• ““What” and “for whom” questionsWhat” and “for whom” questions
• ““How” questions How” questions – How to best practice based on efficacy and How to best practice based on efficacy and
side effects,side effects,
• Decision questionsDecision questions– How much time, training, and cost is entailed How much time, training, and cost is entailed
in the new treatment? Is the clinical benefit in the new treatment? Is the clinical benefit worth the cost? Is there a cost offset?worth the cost? Is there a cost offset?
Research questions that impact practice 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?