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Treatment for Adolescent Marijuana Abuse

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MET/CBT
CM
BPT
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring Adolescent Marijuana Abuse

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Geisel School of Medicine at Dartmouth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

MET/CBT+CM/BPT

MET/CBT+CM

MET/CBT

Arm Description

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

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

Integrated psychosocial counseling. 14 weekly sessions.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2007
Last Updated
July 30, 2015
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00580671
Brief Title
Treatment for Adolescent Marijuana Abuse
Official Title
Behavioral Treatment of Adolescent Marijuana Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
Adolescent Marijuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET/CBT+CM/BPT
Arm Type
Experimental
Arm Description
Integrated psychosocial counseling. 14 weekly session. Twice weekly urine testing. Abstinence-based incentives based on urine test results. 14 weekly behavioral parenting sessions.
Arm Title
MET/CBT+CM
Arm Type
Experimental
Arm Description
Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results.
Arm Title
MET/CBT
Arm Type
Active Comparator
Arm Description
Integrated psychosocial counseling. 14 weekly sessions.
Intervention Type
Behavioral
Intervention Name(s)
MET/CBT
Intervention Description
Weekly Individual Counseling Sessions
Intervention Type
Behavioral
Intervention Name(s)
CM
Intervention Description
Abstinence-based incentives delivered contingent on drug-negative urine test results.
Intervention Type
Behavioral
Intervention Name(s)
BPT
Intervention Description
Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.
Primary Outcome Measure Information:
Title
Marijuana Abstinence (2 Weeks or Greater)
Description
Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.
Time Frame
Testing done twice weekly for 14 weeks.
Title
Marijuana Abstinence (4 Weeks or Greater)
Description
Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.
Time Frame
Twice weekly urine tests for 14 weeks.
Secondary Outcome Measure Information:
Title
Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)
Description
This reflects the mean proportion of days of marijuana abstinence for each participant
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Budney, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisel School of Medicine at Dartmouth
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15908833
Citation
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.
Results Reference
background
PubMed Identifier
26004659
Citation
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.
Results Reference
derived
Links:
URL
http://www.uams.edu/psych/car/
Description
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Treatment for Adolescent Marijuana Abuse

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