- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350285
The Teen Marijuana Check-Up (TMCU3)
Reaching and Motivating Change in Teen Marijuana Smokers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Three hundred adolescents who smoke marijuana (ages 14-19), recruited in four Seattle-area high schools, will be enrolled in the trial. Participants will be recruited either through in-class presentations focusing on marijuana or via referrals from school staff. They will first be assessed regarding use of marijuana, alcohol, and other drugs, as well as pertinent attitudes and goals. Participants will then be randomly assigned to one of three conditions.
- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the Health Educator employing motivational interviewing strategies intended to enhance motivation for reduction or cessation of marijuana use. Specific goals for change and behavior change strategies are discussed with participants who wish support to change their marijuana use.
- The comparison condition involves two educational sessions focusing on the health and behavioral effects of marijuana.
- The third condition (delayed treatment control) involves a minimal baseline assessment followed three months later by a reassessment interview. Those assigned to this condition will then be given their choice of either active treatment.
Following completion of their two intervention sessions, participants in the two active treatments will be offered an additional four sessions of cognitive-behavioral skills training in which the focus is strategies in quitting marijuana. All participants will be reassessed at 3 and 12 months following their initial assessment interviews.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Individuals who contact the project will be screened according to the following inclusion criteria:
- age (14-19 years old),
- grade level (freshmen through seniors) and
- marijuana use (smoked 9 or more days in past 30).
Exclusion Criteria: Individuals will be excluded if:
- they are not fluent in English,
- they have a thought disorder that precludes full participation,
- they refuse to accept randomization to condition.
In addition to the inclusion and exclusion criteria, participants who appear to be in psychological or physical distress will be assessed further and referred to other services as appropriate. The need for other services will not necessarily preempt participation in the TMCU unless the individual is incapable or unwilling to complete the protocol. As was the case in our Stage 1b trial, all ineligible applicants will be offered a single feedback session, and the Strategies That Work booklet will be offered to those who indicate any interest in reducing or quitting marijuana use.
Study Plan
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 |
---|---|
Experimental: 1
Motivational enhancement therapy
|
Personal feedback with counselor using motivational interviewing strategies.
|
Active Comparator: 2
Marijuana education
|
Information about health and behavioral effects of marijuana use.
|
No Intervention: 3
Delayed treatment control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-report of marijuana use
Time Frame: 3 months and 12 months
|
3 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accepting abstinence-focused counseling
Time Frame: 3 months and 12 months
|
3 months and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roger A Roffman, DSW, University of Washington School of Social Work
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-8666-G-05
- R01DA014296 (U.S. NIH Grant/Contract)
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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