- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350649
Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
September 26, 2011 updated by: Yale University
Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends.
Treatment retention and compliance are associated with enhanced treatment outcomes in CBT.
Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes.
Despite their many strengths, neither CBT nor CM is universally effective.
It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively.
To maximize the effectiveness of CBT, the investigators will evaluate the benefit of adding CM, with reinforcement for session attendance and homework completion, to standard individual CBT for outpatient marijuana abusers, in order to expose participants to more skill training and opportunities for practice of skills.
To maximize the effectiveness and durability of CM, we will evaluate the benefit of integrating it with skills training, specifically designed to reduce drop off effects, in order to extend CM's benefits beyond the active treatment period.
We propose to conduct a Stage II trial which will: (1) Evaluate the efficacy of four conditions for 160 marijuana dependent outpatients: (a) Standard CBT, (b) CBT with CM reinforcement for attendance and completing homework (CBT+CM/adherence), (c) CM for abstinence alone (CM/abstinence), (d) CM for abstinence integrated with CBT (CM/abstinence+CBT), and (2) Evaluate the longer-term durability and / or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up.
Secondary aims will be to conduct (a) detailed process studies to evaluate whether the proposed enhancements affect proximal and distal outcomes as hypothesized and (b) economic analyses.
Study treatments will last 12 weeks.
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06512
- ASAP/1 Long Wharf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 year old marijuana dependent
- willing to sign consent
- no use of prescribed psychotropic drugs
- willing to give three individuals as contacts
- willing to accept randomization
- read and write English (third grade level)
Exclusion Criteria:
- unable to commit to 1 year follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
manualized delivery of CBT by trained clinicians
|
Manualized delivery of CBT by trained clinicians
|
Active Comparator: 2
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
|
CBT and Clinical Management for attendance and completing homework
|
Experimental: 3
Contingency Management for abstinence alone (CM/abstinence)
|
Contingency Management
|
Active Comparator: 4
Contingency Management integrated with CBT (CM/abstinence+CBT)
|
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Economic analysis with use of PACC-SAT
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Carroll, PhD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 7, 2006
First Submitted That Met QC Criteria
July 7, 2006
First Posted (Estimate)
July 11, 2006
Study Record Updates
Last Update Posted (Estimate)
September 27, 2011
Last Update Submitted That Met QC Criteria
September 26, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
- coping
- cognitive behavioral therapy
- combination therapy
- psychotherapy
- drug abuse therapy
- outpatient care
- therapy compliance
- outcomes research
- patient oriented research
- human therapy evaluation
- behavior modification
- human subjects
- neuropsychological test
- drug addition
- clinical trial phase II
- drug and alcohol abstinence
- longitudinal human study
- psychological reinforcement
- behavior and social research tag
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0407026913
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Dependence
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Marijuana DependenceUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Marijuana DependenceUnited States
-
York UniversityUniversity of ManitobaCompletedMarijuana Use | Marijuana DependenceCanada
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)Completed
-
Medical University of South CarolinaCompleted
-
Southern Illinois University CarbondaleNational Institute on Drug Abuse (NIDA)Completed
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA); Food and Drug Administration (FDA)CompletedMarijuana DependenceUnited States
-
University of MinnesotaCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedMarijuana DependenceUnited States
-
Medical University of South CarolinaCompletedMarijuana DependenceUnited States
Clinical Trials on Standard CBT
-
Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre CopenhagenCompletedPanic Disorder | Depression, Unipolar | Anxiety Disorder SocialDenmark
-
National Institute of Diabetes and Digestive and...Completed
-
Northwestern UniversityCompleted
-
University of South FloridaCompletedPosttraumatic Stress DisorderUnited States
-
University of South FloridaCompleted
-
VA Office of Research and DevelopmentCompleted
-
VA Office of Research and DevelopmentVA Finger Lakes Healthcare SystemRecruiting
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)Completed
-
Rochester Institute of TechnologyNot yet recruitingSubstance Use Disorders | Alcohol Use Disorder | Stimulant-Related Disorder
-
University of MiamiUniversity of MinnesotaCompletedSmoking | Smoking CessationUnited States