Treatment for Adolescent Marijuana Abuse

Marijuana Abuse Clinical Trial

Official title:

Behavioral Treatment of Adolescent Marijuana Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580671
• Other study ID #: 75185
• Secondary ID: 5R01DA015186-075
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 30, 2015
• Start date: November 2007
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Geisel School of Medicine at Dartmouth	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kamon J, Budney A, Stanger C. A contingency management intervention for adolescent marijuana abuse and conduct problems. J Am Acad Child Adolesc Psychiatry. 2005 Jun;44(6):513-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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	No