AzTrials
AzTrials

Marijuana AbuseNCT00580671

Treatment for Adolescent Marijuana Abuse

A study testing MET/CBT, CM and BPT in people with Marijuana Abuse, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Marijuana Abuse
What is being tested?
MET/CBT, CM and BPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteUnited States
Study dates
Nov 2007to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Geisel School of Medicine at Dartmouth

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: 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.

Conditions
Marijuana Abuse
Being tested
MET/CBT, CM, BPT
Keywords
Adolescent Marijuana Abuse
Medical subject headings
Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MET/CBTBehavioural

    Weekly Individual Counseling Sessions

  • CMBehavioural

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

  • BPTBehavioural

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

Study groups in NCT00580671
Study groupRoleWhat they receive
MET/CBT+CM/BPTExperimentalIntegrated psychosocial counseling. 14 weekly session. Twice weekly urine testing. Abstinence-based incentives based on urine test results. 14 weekly behavioral parenting sessions.
Receives: Behavioral: MET/CBT; Behavioral: CM; Behavioral: BPT
MET/CBT+CMExperimentalIntegrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results.
Receives: Behavioral: MET/CBT; Behavioral: CM
MET/CBTActive comparatorIntegrated psychosocial counseling. 14 weekly sessions.
Receives: Behavioral: MET/CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Testing done twice weekly for 14 weeks.

  2. 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.

    Measured: Twice weekly urine tests for 14 weeks.

Secondary outcomes (1)
  1. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00580671
Sponsor's protocol ID
75185
Other IDs
5R01DA015186-07, 5R01DA015186-08
Status last verified
Jul 2015
First submitted
21 Dec 2007
Last updated
20 Aug 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 15908833
  • 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.

    PubMed 26004659

Questions about this trial

What is this clinical trial studying?

A study testing MET/CBT, CM and BPT in people with Marijuana Abuse, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marijuana Abstinence (2 Weeks or Greater) (time frame: Testing done twice weekly for 14 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00580671, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in