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Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard CBT
CBT+CM/adherence
CM/abstinence
CM/abstinence+CBT
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASAP/1 Long Wharf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

manualized delivery of CBT by trained clinicians

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

Contingency Management for abstinence alone (CM/abstinence)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Economic analysis with use of PACC-SAT

Full Information

First Posted
July 7, 2006
Last Updated
September 26, 2011
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00350649
Brief Title
Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
Official Title
Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
manualized delivery of CBT by trained clinicians
Arm Title
2
Arm Type
Active Comparator
Arm Description
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
Arm Title
3
Arm Type
Experimental
Arm Description
Contingency Management for abstinence alone (CM/abstinence)
Arm Title
4
Arm Type
Active Comparator
Arm Description
Contingency Management integrated with CBT (CM/abstinence+CBT)
Intervention Type
Behavioral
Intervention Name(s)
Standard CBT
Intervention Description
Manualized delivery of CBT by trained clinicians
Intervention Type
Behavioral
Intervention Name(s)
CBT+CM/adherence
Intervention Description
CBT and Clinical Management for attendance and completing homework
Intervention Type
Behavioral
Intervention Name(s)
CM/abstinence
Intervention Description
Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
CM/abstinence+CBT
Intervention Description
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
Primary Outcome Measure Information:
Title
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Economic analysis with use of PACC-SAT
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Carroll, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASAP/1 Long Wharf
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States

12. IPD Sharing Statement

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Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

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