Treatment for Adolescent Marijuana Abuse

July 30, 2015 updated by: Alan J. Budney, Dartmouth-Hitchcock Medical Center

Behavioral Treatment of Adolescent Marijuana Use

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Geisel School of Medicine at Dartmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: MET/CBT+CM/BPT
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
Weekly Individual Counseling Sessions
Behavioral: CM
Abstinence-based incentives delivered contingent on drug-negative urine test results.
Behavioral: BPT
Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.
Experimental: MET/CBT+CM
Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results.
Behavioral: MET/CBT
Weekly Individual Counseling Sessions
Behavioral: CM
Abstinence-based incentives delivered contingent on drug-negative urine test results.
Active Comparator: MET/CBT
Integrated psychosocial counseling. 14 weekly sessions.
Behavioral: MET/CBT
Weekly Individual Counseling Sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marijuana Abstinence (2 Weeks or Greater)
Time Frame: Testing done twice weekly for 14 weeks.
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)
Time Frame: Twice weekly urine tests for 14 weeks.
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Alan J Budney, Ph.D., Dartmouth College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75185
  • 5R01DA015186-07 (U.S. NIH Grant/Contract)
  • 5R01DA015186-08 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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