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Treatment for Adolescent Marijuana Abuse

Behavioral Treatment of Adolescent Marijuana Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00580671
Enrollment
153
Registered
2007-12-27
Start date
2007-11-30
Completion date
2013-12-31
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Abuse

Keywords

Adolescent Marijuana Abuse

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.

Interventions

BEHAVIORALMET/CBT

Weekly Individual Counseling Sessions

BEHAVIORALCM

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

BEHAVIORALBPT

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Marijuana Abstinence (2 Weeks or Greater)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)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.

Secondary

MeasureTime frameDescription
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 proportionThis reflects the mean proportion of days of marijuana abstinence for each participant

Countries

United States

Participant flow

Recruitment details

Recruitment opened in November 2007 and closed in February 2011. Participants were referred to the study for substance abuse treatment by school administrators, the juvenile justice system, community therapists, physicians or were self-referred. The study took place at an outpatient psychiatry clinic.

Pre-assignment details

Clients were enrolled into the study and assessed for eligibility, if eligible they were given the choice to proceed. Reasons for ineligibility included no marijuana (MJ) use in past 30 days, failure to meet MJ abuse/dependence criteria, met dependence for another substance, no parent participant, plans to move away, low IQ

Participants by arm

ArmCount
MET/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
51
MET/CBT+CM
Motivational Enhancement Therapy (MET)/CBT+CM
51
MET/CBT
Motivational Enhancement Therapy (MET)/CBT
51
Total153

Baseline characteristics

CharacteristicMET/CBT+CMMET/CBTMET/CBT+CM/BPTTotal
Age, Categorical
<=18 years
51 Participants51 Participants51 Participants153 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous15.9 years
STANDARD_DEVIATION 1.3
15.7 years
STANDARD_DEVIATION 1.3
15.8 years
STANDARD_DEVIATION 1.4
15.8 years
STANDARD_DEVIATION 1.4
Region of Enrollment
United States
51 participants51 participants51 participants153 participants
Sex: Female, Male
Female
6 Participants4 Participants7 Participants17 Participants
Sex: Female, Male
Male
45 Participants47 Participants44 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
7 / 518 / 514 / 51
serious
Total, serious adverse events
15 / 518 / 516 / 51

Outcome results

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.

Time frame: Testing done twice weekly for 14 weeks.

ArmMeasureValue (NUMBER)
MET/CBT+CM/BPTMarijuana Abstinence (2 Weeks or Greater)72.5 percentage of participants
MET/CBT+CMMarijuana Abstinence (2 Weeks or Greater)68.6 percentage of participants
MET/CBTMarijuana Abstinence (2 Weeks or Greater)45.1 percentage of participants
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.

Time frame: Twice weekly urine tests for 14 weeks.

ArmMeasureValue (NUMBER)
MET/CBT+CM/BPTMarijuana Abstinence (4 Weeks or Greater)58.8 percentage of participants
MET/CBT+CMMarijuana Abstinence (4 Weeks or Greater)64.7 percentage of participants
MET/CBTMarijuana Abstinence (4 Weeks or Greater)35.3 percentage of participants
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

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

Population: Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.

ArmMeasureValue (MEAN)Dispersion
MET/CBT+CM/BPTProportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks).8058 proportion of marijuana abstinent daysStandard Deviation 0.29419
MET/CBT+CMProportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks).8162 proportion of marijuana abstinent daysStandard Deviation 0.29143
MET/CBTProportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks).7915 proportion of marijuana abstinent daysStandard Deviation 0.26115

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026