Teen Marijuana Check-Up

Cannabis Use Disorder Clinical Trial

Official title:

Reaching and Motivating Change in Teen Marijuana Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109563
• Other study ID #: 37852-G
• Secondary ID: 2R01DA014296-09A
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2010
• Last updated: October 25, 2016
• Start date: March 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions.

HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.

Description:

The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions.

All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

1. age (14-19 years old),

2. grade level (9th through 11th) and

3. marijuana use.

Exclusion Criteria:

Individuals will be excluded if:

1. they are not fluent in English,

2. they have a thought disorder that precludes full participation,

3. they refuse to accept randomization to condition,

4. they are high school seniors.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Behavioral:
• Marijuana Check-Ins
The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Denise Walker	National Institute on Drug Abuse (NIDA), Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency (number of days) of marijuana use	Global Appraisal of Individual Needs - I (self-report measure)	60 days	No
Primary	treatment utilization	Global Appraisal of Individual Needs - I	90 days	No
Primary	marijuana abuse/dependence symptoms	Global Appraisal of Individual Needs - I	60 days	No
Primary	engagement in cognitive behavioral skills training sessions	Frequency of attendance at optional in-school counseling sessions	90 days	No
Secondary	self-efficacy	Self-efficacy scale that assesses self-efficacy for avoiding marijuana use	90 days	No
Secondary	normative perceptions of peer marijuana use	Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age	90 days	No