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Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

NCT ID: NCT00350649

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Marijuana Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

manualized delivery of CBT by trained clinicians

Group Type EXPERIMENTAL

Standard CBT

Intervention Type BEHAVIORAL

Manualized delivery of CBT by trained clinicians

2

CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)

Group Type ACTIVE_COMPARATOR

CBT+CM/adherence

Intervention Type BEHAVIORAL

CBT and Clinical Management for attendance and completing homework

3

Contingency Management for abstinence alone (CM/abstinence)

Group Type EXPERIMENTAL

CM/abstinence

Intervention Type BEHAVIORAL

Contingency Management

4

Contingency Management integrated with CBT (CM/abstinence+CBT)

Group Type ACTIVE_COMPARATOR

CM/abstinence+CBT

Intervention Type BEHAVIORAL

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

Interventions

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Standard CBT

Manualized delivery of CBT by trained clinicians

Intervention Type BEHAVIORAL

CBT+CM/adherence

CBT and Clinical Management for attendance and completing homework

Intervention Type BEHAVIORAL

CM/abstinence

Contingency Management

Intervention Type BEHAVIORAL

CM/abstinence+CBT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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ASAP/1 Long Wharf

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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0407026913

Identifier Type: -

Identifier Source: org_study_id