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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00350649 |
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.
Condition | Intervention | Phase |
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Marijuana Dependence |
Behavioral: Standard CBT Behavioral: CBT+CM/adherence Behavioral: CM/abstinence Behavioral: CM/abstinence+CBT |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management |
Estimated Enrollment: | 160 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
manualized delivery of CBT by trained clinicians
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Behavioral: Standard CBT
Manualized delivery of CBT by trained clinicians
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2: Active Comparator
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
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Behavioral: CBT+CM/adherence
CBT and Clinical Management for attendance and completing homework
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3: Experimental
Contingency Management for abstinence alone (CM/abstinence)
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Behavioral: CM/abstinence
Contingency Management
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4: Active Comparator
Contingency Management integrated with CBT (CM/abstinence+CBT)
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Behavioral: CM/abstinence+CBT
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: JoAnna DePiono, BA | 203-974-5731 | joanna.depino@yale.edu |
Contact: Rhonda Pruzinski, BA | 203-974-5740 | rhonda.pruzinski@yale.edu |
United States, Connecticut | |
ASAP/1 Long Wharf | Recruiting |
New Haven, Connecticut, United States, 06512 |
Principal Investigator: | Kathleen Carroll, PhD | Yale School of Medicine |
Responsible Party: | Yale University ( Kathleen Carroll, PhD ) |
Study ID Numbers: | 0407026913 |
Study First Received: | July 7, 2006 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00350649 |
Health Authority: | United States: Federal Government |
behavior modification cognitive behavioral therapy combination therapy drug abuse therapy drug addition human therapy evaluation psychotherapy clinical trial phase II coping drug and alcohol abstinence |
longitudinal human study outcomes research outpatient care psychological reinforcement therapy compliance behavior and social research tag human subjects neuropsychological test patient oriented research |
Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Marijuana Abuse Ethanol |