Overview

This trial is active, not recruiting.

Condition marijuana abuse
Treatments met/cbt, cm, bpt
Sponsor Dartmouth-Hitchcock Medical Center
Collaborator National Institutes of Health (NIH)
Start date November 2007
End date July 2012
Trial size 153 participants
Trial identifier NCT00580671, 5R01DA015186-07, 5R01DA015186-08, 75185

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Integrated psychosocial counseling. 14 weekly session. Twice weekly urine testing. Abstinence-based incentives based on urine test results. 14 weekly behavioral parenting sessions.
met/cbt
Weekly Individual Counseling Sessions
cm
Abstinence-based incentives delivered contingent on drug-negative urine test results.
bpt
Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.
(Experimental)
Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results.
met/cbt
Weekly Individual Counseling Sessions
cm
Abstinence-based incentives delivered contingent on drug-negative urine test results.
(Active Comparator)
Integrated psychosocial counseling. 14 weekly sessions.
met/cbt
Weekly Individual Counseling Sessions

Primary Outcomes

Measure
Marijuana Abstinence (2 Weeks or Greater)
time frame: Testing done twice weekly for 14 weeks.
Marijuana Abstinence (4 Weeks or Greater)
time frame: Twice weekly urine tests for 14 weeks.

Secondary Outcomes

Measure
Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)
time frame: 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

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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)

Additional Information

Official title Behavioral Treatment of Adolescent Marijuana Use
Principal investigator Alan J Budney, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center.