- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00107588
Marijuana Treatment Project - 3 (MTP-3)
July 27, 2017 updated by: Mark Litt, UConn Health
Contingency Management for Marijuana Dependence
The goal of this research is to improve treatment outcome for marijuana-dependent individuals.
The current study builds on the findings of our prior NIDA-funded marijuana treatment study in which improved client outcomes were associated with greater treatment attendance, greater client self-efficacy, and greater use of coping skills.
We will use a contingency management paradigm to provide tangible reinforcement for completing homework assignments that are designed to enhance coping skills.
It is anticipated that this will result in greater homework compliance, leading to greater self-efficacy regarding one's ability to cope with high-risk situations.
Improved self-efficacy will enhance the likelihood of employing coping skills in high-risk situations, thereby increasing the probability of achieving and maintaining abstinence.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants will receive an intervention combining one session of motivational enhancement therapy with eight sessions of cognitive-behavioral coping skills therapy (MET+CBT).
A contingency management procedure will be added to this intervention, providing reinforcement for completion of homework, as verified by call-ins to an Interactive Voice Recording (IVR) system.
Outcomes will be compared to an MET+CBT intervention in which reinforcement will be provided for marijuana-free urine specimens, and to a control group that receives Case Management.
Recruitment of 234 marijuana-dependent participants will occur over a three-year period.
They will be randomly assigned to one of the three 9-session interventions.
Treatment will be individual, manualized, and provided on an outpatient basis.
Pretreatment assessments will obtain baseline data; follow-up assessments at three-month intervals for one year will evaluate marijuana use outcomes, other drug or alcohol use, and psychosocial functioning.
It is anticipated that the intervention in which completion of homework is reinforced will result in the best outcomes.
The mechanisms by which the interventions result in behavior change will be the specific focus of attention in this study.
Study Type
Interventional
Enrollment (Actual)
215
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030-3910
- University of Connecticut Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cannabis dependence
- Willing to accept random assignment to interventions
Exclusion Criteria:
- Current dependence on alcohol or other drugs
- Problems that require inpatient hospitalization
- Reading ability below fifth grade level
- Lack of reliable transportation to treatment
- Excessive commuting distance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Case Management
|
Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.
|
|
Experimental: Reinforcement for homework completion
|
Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills
|
|
Active Comparator: Reinforcement for Abstinence
|
Provides contingent reinforcement for submitting marijuana-free urine specimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Marijuana abstinence
Time Frame: One-year follow-up period
|
One-year follow-up period
|
|
Self-efficacy, use of coping skills, and treatment attendance
Time Frame: During 2-month treatment period
|
During 2-month treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Continuous abstinence will be predicted by (a) treatment attendance; (b) posttreatment self-efficacy for coping; and (c) use of coping skills
Time Frame: One-year follow-up period
|
One-year follow-up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark D Litt, Ph.D., UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 5, 2005
First Submitted That Met QC Criteria
April 5, 2005
First Posted (Estimate)
April 6, 2005
Study Record Updates
Last Update Posted (Actual)
July 28, 2017
Last Update Submitted That Met QC Criteria
July 27, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-12728-06
- R01DA012728-06 (U.S. NIH Grant/Contract)
- R01-12728-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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