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Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

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ClinicalTrials.gov Identifier: NCT00350649
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : September 27, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Marijuana Dependence Behavioral: Standard CBT Behavioral: CBT+CM/adherence Behavioral: CM/abstinence Behavioral: CM/abstinence+CBT Phase 2

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
Study Start Date : December 2004
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
manualized delivery of CBT by trained clinicians
Behavioral: Standard CBT
Manualized delivery of CBT by trained clinicians
Active Comparator: 2
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
Behavioral: CBT+CM/adherence
CBT and Clinical Management for attendance and completing homework
Experimental: 3
Contingency Management for abstinence alone (CM/abstinence)
Behavioral: CM/abstinence
Contingency Management
Active Comparator: 4
Contingency Management integrated with CBT (CM/abstinence+CBT)
Behavioral: CM/abstinence+CBT
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician


Outcome Measures

Primary Outcome Measures :
  1. Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Economic analysis with use of PACC-SAT [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350649


Locations
United States, Connecticut
ASAP/1 Long Wharf
New Haven, Connecticut, United States, 06512
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kathleen Carroll, PhD Yale School of Medicine
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00350649     History of Changes
Other Study ID Numbers: 0407026913
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Yale University:
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

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders