Official Title: “Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: September 2010

We propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively. To maximize the effectiveness of CBT, we 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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • manualized delivery of CBT by trained clinicians
• Active Comparator: 2
  • CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
• Experimental: 3
  • Contingency Management for abstinence alone (CM/abstinence)
• Active Comparator: 4
  • Contingency Management integrated with CBT (CM/abstinence+CBT)

Primary Measures

• Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Economic analysis with use of PACC-SAT
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Kathleen Carroll, PhD Principal Investigator Yale School of Medicine  

Overall Contact: Sally Vitolo, BA 203-974-5740 sally.vitolo@yale.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350649

Study ID Number: 0407026913

ClinicalTrials.gov Identifier: NCT00350649

Health Authority: United States: Federal Government