Marijuana Treatment Project - 3 (MTP-3)
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | April 5, 2005 | ||||
Last Updated Date | May 10, 2012 | ||||
Start Date ICMJE | February 2007 | ||||
Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
|
||||
Change History | Complete list of historical versions of study NCT00107588 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
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 ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Marijuana Treatment Project - 3 | ||||
Official Title ICMJE | Contingency Management for Marijuana Dependence | ||||
Brief Summary | 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. |
||||
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 ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Marijuana Dependence | ||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 234 | ||||
Estimated Completion Date | August 2012 | ||||
Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00107588 | ||||
Other Study ID Numbers ICMJE | NIDA-12728-06, R01DA012728-06, R01-12728-06 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Mark Litt, University of Connecticut Health Center | ||||
Study Sponsor ICMJE | University of Connecticut Health Center | ||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Investigators ICMJE |
|
||||
Information Provided By | University of Connecticut Health Center | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |