Treatment for Adolescent Marijuana Abuse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alan J. Budney, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00580671
First received: December 21, 2007
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Marijuana Abuse
Behavioral: MET/CBT
Behavioral: CM
Behavioral: BPT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Adolescent Marijuana Use

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Marijuana Abstinence (2 Weeks or Greater) [ Time Frame: Testing done twice weekly for 14 weeks. ] [ Designated as safety issue: No ]
    Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.

  • Marijuana Abstinence (4 Weeks or Greater) [ Time Frame: Twice weekly urine tests for 14 weeks. ] [ Designated as safety issue: No ]
    Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    This reflects the mean proportion of days of marijuana abstinence for each participant


Enrollment: 153
Study Start Date: November 2007
Estimated Study Completion Date: August 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580671

Locations
United States, New Hampshire
Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Alan J Budney, Ph.D. Geisel School of Medicine at Dartmouth
  More Information

Publications:
Responsible Party: Alan J. Budney, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00580671     History of Changes
Other Study ID Numbers: 75185, 5R01DA015186-07, 5R01DA015186-08
Study First Received: December 21, 2007
Results First Received: March 25, 2013
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Adolescent Marijuana Abuse

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014