A Phase 2 interventional study of Standard CBT and CBT+CM/adherence in Marijuana Dependence, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-09-27.
Sponsored by Yale University · Phase 2, Interventional, and Treatment
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.
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.
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 205 is above the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
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Exclusion Criteria:
manualized delivery of CBT by trained clinicians
Behavioral: Standard CBT
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
Behavioral: CBT+CM/adherence
Contingency Management for abstinence alone (CM/abstinence)
Behavioral: CM/abstinence
Contingency Management integrated with CBT (CM/abstinence+CBT)
Behavioral: CM/abstinence+CBT
Manualized delivery of CBT by trained clinicians
CBT and Clinical Management for attendance and completing homework
Contingency Management
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
Time frame: 12 weeks
Economic analysis with use of PACC-SAT
Time frame: 12 weeks
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Yale University