Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

Marijuana Dependence Clinical Trial

Official title:

Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350649
• Other study ID #: 0407026913
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2006
• Last updated: September 26, 2011
• Start date: December 2004
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Behavioral:
• Standard CBT
Manualized delivery of CBT by trained clinicians
• CBT+CM/adherence
CBT and Clinical Management for attendance and completing homework
• CM/abstinence
Contingency Management
• CM/abstinence+CBT
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician

Locations

Country	Name	City	State
United States	ASAP/1 Long Wharf	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens		12 weeks	No
Secondary	Economic analysis with use of PACC-SAT		12 weeks	No