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OpenTrials
Completed

NCT Number: NCT00350649

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.

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Key information

Conditions

Marijuana Dependence Alcohol Abstinence Behavior Chemically-Induced Disorders Drinking Behavior Health Behavior Marijuana Abuse Mental Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ASAP/1 Long Wharf

New Haven, Connecticut, 06512, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard CBT

Behavioral

Manualized delivery of CBT by trained clinicians

CBT+CM/adherence

Behavioral

CBT and Clinical Management for attendance and completing homework

CM/abstinence

Behavioral

Contingency Management

CM/abstinence+CBT

Behavioral

Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician

Primary outcomes

  1. Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens

    Time frame: 12 weeks

Secondary outcomes

  1. Economic analysis with use of PACC-SAT

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 11, 2006
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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