NCT00580671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 5, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 20, 2015

Status Verified

July 1, 2015

Enrollment Period

4.7 years

First QC Date

December 21, 2007

Results QC Date

March 25, 2013

Last Update Submit

July 30, 2015

Conditions

Keywords

Adolescent Marijuana Abuse

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)

    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

Study Arms (3)

MET/CBT+CM/BPT

EXPERIMENTAL

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/CBTBehavioral: CMBehavioral: BPT

MET/CBT+CM

EXPERIMENTAL

Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results.

Behavioral: MET/CBTBehavioral: CM

MET/CBT

ACTIVE COMPARATOR

Integrated psychosocial counseling. 14 weekly sessions.

Behavioral: MET/CBT

Interventions

MET/CBTBEHAVIORAL

Weekly Individual Counseling Sessions

MET/CBTMET/CBT+CMMET/CBT+CM/BPT
CMBEHAVIORAL

Abstinence-based incentives delivered contingent on drug-negative urine test results.

MET/CBT+CMMET/CBT+CM/BPT
BPTBEHAVIORAL

Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.

MET/CBT+CM/BPT

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

  • 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. doi: 10.1097/01.chi.0000159949.82759.64.

    PMID: 15908833BACKGROUND
  • Stanger C, Ryan SR, Scherer EA, Norton GE, Budney AJ. Clinic- and home-based contingency management plus parent training for adolescent cannabis use disorders. J Am Acad Child Adolesc Psychiatry. 2015 Jun;54(6):445-53.e2. doi: 10.1016/j.jaac.2015.02.009. Epub 2015 Feb 28.

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Alan J. Budney, PhD
Organization
Geisel School of Medicine at Dartmouth

Study Officials

  • Alan J Budney, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

November 1, 2007

Primary Completion

July 1, 2012

Study Completion

December 1, 2013

Last Updated

August 20, 2015

Results First Posted

June 5, 2013

Record last verified: 2015-07

Locations