Treatment for Adolescent Marijuana Abuse

Study Overview
=================
Brief Summary
-----------------
Marijuana remains the most prevalent illicit substance used by adolescents and the number of adolescents receiving treatment for marijuana abuse more than tripled during the last decade. A small number of clinical trials suggest that family-based and individual interventions have efficacy for treating adolescent substance abuse. However, even with these interventions most adolescents fail to reduce their substance use substantially, thus, there remains much room for improvement of treatment services. The overarching goal of this project is to develop and test novel behavioral treatments to enhance treatment outcome in this important treatment population, and in so doing, learn more about mechanisms of change that have broader implications for addiction science. In our initial Stage IB project Behavioral Treatment for Adolescent Marijuana Abuse, we created, manualized, and pilot tested a unique contingency-management (CM) intervention that combined abstinence-based voucher incentives with contingency management training for parents. A small randomized, clinical trial provided encouraging results. When added to a commonly used cognitive-behavior therapy, CM improved rates of sustained abstinence during treatment. Adolescents receiving this intervention were less likely to relapse over the 9-month follow-up period, however this finding was not as robust as the observed during treatment effects, most likely due to the small sample size and associated low power to detect effects. Despite strong indicators of the efficacy of this CM intervention, there remained room for improvement in increasing rates of treatment response and reducing rates of relapse. Hypothesized mediators and moderators of change indicated that changes in parenting had direct effects on post-treatment marijuana abstinence outcomes, and that abstinence early in treatment was a robust predictor of the CM treatment effect. This proposal will systematically replicate and extend these findings. A Stage II trial will compare three treatment conditions: (1) cognitive behavior therapy (CBT only); (2) CBT plus CM; and (3) CBT plus an enhanced CM model targeting increased early abstinence rates, parenting skills, and maintenance of effects. Replicating the initial demonstration of the positive effects of CM will extend the scientific evidence for use of CM to increase treatment efficacy for substance-abusing adolescents. Testing an enhanced CM model will determine if modifications that are consistent with the underlying behavioral principles and empiricism supporting CM interventions can result in improved outcomes. Last, assessment of potential mechanisms of action, particularly parenting, adolescent psychopathology and impulsivity, will provide scientific information directly relevant to future development of more effective intervention and prevention models of adolescent substance abuse, and will inform us about fundamental mechanisms operating in drug-dependence.

Official Title
-----------------
Behavioral Treatment of Adolescent Marijuana Use

Conditions
-----------------
Marijuana Abuse

Intervention / Treatment
-----------------
* Behavioral: MET/CBT
* Behavioral: CM
* Behavioral: BPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 to 18 years old (if 18, they must attend high school and live at home) Report using marijuana during the previous 30 days or provide a marijuana- positive urine test Meet criteria for cannabis abuse or dependence Have a parent/guardian who can participate Live within a 30-minute driving range from the clinic Exclusion Criteria: Currently meet DSM criteria for dependence on alcohol or other illicit drugs other than marijuana (use/abuse of other drugs will not be excluded) Exhibit active psychosis Have severe medical or psychiatric illness limiting participation Are pregnant or breast-feeding (youth only)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MET/CBT+CM/BPT<br>Integrated psychosocial counseling. 14 weekly session. Twice weekly urine testing. Abstinence-based incentives based on urine test results. 14 weekly behavioral parenting sessions. | Behavioral: MET/CBT<br>* Weekly Individual Counseling Sessions<br>Behavioral: CM<br>* Abstinence-based incentives delivered contingent on drug-negative urine test results.<br>Behavioral: BPT<br>* Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.<br>|
| Experimental: MET/CBT+CM<br>Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results. | Behavioral: MET/CBT<br>* Weekly Individual Counseling Sessions<br>Behavioral: CM<br>* Abstinence-based incentives delivered contingent on drug-negative urine test results.<br>|
| Active Comparator: MET/CBT<br>Integrated psychosocial counseling. 14 weekly sessions. | Behavioral: MET/CBT<br>* Weekly Individual Counseling Sessions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marijuana Abstinence (2 Weeks or Greater) | Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment. | Testing done twice weekly for 14 weeks. | 
| Marijuana Abstinence (4 Weeks or Greater) | Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment. | Twice weekly urine tests for 14 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks) | This reflects the mean proportion of days of marijuana abstinence for each participant | This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent Marijuana Abuse