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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MET/CBT; Behavioral: CM; Behavioral: BPT |
| MET/CBT+CM | Experimental | Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results. Receives: Behavioral: MET/CBT; Behavioral: CM |
| MET/CBT | Active comparator | Integrated 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.
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.
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)
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.
- First posted27 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alan J. Budney, Dartmouth-Hitchcock Medical Center
- Investigators
- Alan J Budney, Ph.D., Principal investigator, Dartmouth College
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15908833Stanger 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Adolescent Marijuana Use
- ClinicalTrials.gov ID
- NCT00580671
- Acronym / sponsor ID
- 75185
- Conditions
- Marijuana Abuse
- Keywords
- Adolescent Marijuana Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 5 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MET/CBT+CM/BPT | Experimental | Behavioral: MET/CBT, Behavioral: CM, Behavioral: BPTIntegrated psychosocial counseling. 14 weekly session. Twice weekly urine testing. Abstinence-based incentives based on urine test results. 14 weekly behavioral parenting sessions. |
| MET/CBT+CM | Experimental | Behavioral: MET/CBT, Behavioral: CMIntegrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results. |
| MET/CBT | Active comparator | Behavioral: MET/CBTIntegrated psychosocial counseling. 14 weekly sessions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MET/CBTWeekly Individual Counseling Sessions | Behavioural | MET/CBT, MET/CBT+CM, MET/CBT+CM/BPT |
| CMAbstinence-based incentives delivered contingent on drug-negative urine test results. | Behavioural | MET/CBT+CM, MET/CBT+CM/BPT |
| BPTBehavioral parent training involve 14 weekly counseling curriculum to improve parenting skills. | Behavioural | MET/CBT+CM/BPT |
Primary outcome
Marijuana Abstinence (2 Weeks or Greater)
Time frame: Testing done twice weekly for 14 weeks.
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.
Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15908833Kamon 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.
- Derived from this study: PubMed 26004659Stanger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan J Budney, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
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.