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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA015186-07 | U.S. NIH Grant/Contract | View source | |
| 5R01DA015186-08 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MET/CBT+CM | Experimental | Integrated psychosocial counseling. 14 weekly sessions. Twice weekly urine testing. Abstinence-based incentives based on urine test results. |
|
| MET/CBT | Active Comparator | Integrated psychosocial counseling. 14 weekly sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MET/CBT | Behavioral | Weekly Individual Counseling Sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Budney, Ph.D. | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisel School of Medicine at Dartmouth | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15908833 | Background | 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. | |
| 26004659 | Derived | 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. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MET/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT) |
| FG001 | MET/CBT+CM | Motivational Enhancement Therapy (MET)/CBT+CM |
| FG002 | MET/CBT | Motivational Enhancement Therapy (MET)/CBT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MET/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/CBT+CM/BPT |
| BG001 | MET/CBT+CM | Motivational Enhancement Therapy (MET)/CBT+CM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | Testing done twice weekly for 14 weeks. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MET/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/CBT+CM/BPT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Residential Treatment for Substance Use | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrested | General disorders | Arrest not resulting in boot camp, detention, or incarceration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan J. Budney, PhD | Geisel School of Medicine at Dartmouth | 855-290-2822 | alan.j.budney@dartmouth.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| CM | Behavioral | Abstinence-based incentives delivered contingent on drug-negative urine test results. |
|
| BPT | Behavioral | Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills. |
|
| BG002 | MET/CBT | Motivational Enhancement Therapy (MET)/CBT |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Motivational Enhancement Therapy (MET)/CBT
|
|
| 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 | Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis. | Posted | Mean | Standard Deviation | proportion of marijuana abstinent days | 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 |
|
|
|
| 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. | Posted | Number | percentage of participants | Twice weekly urine tests for 14 weeks. |
|
|
|
| 15 |
| 51 |
| 7 |
| 51 |
| EG001 | MET/CBT+CM | Motivational Enhancement Therapy (MET)/CBT+CM | 8 | 51 | 8 | 51 |
| EG002 | MET/CBT | Motivational Enhancement Therapy (MET)/CBT | 6 | 51 | 4 | 51 |
| Hospitatlization or Residential Treatment for Mental Health | Psychiatric disorders |
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| Boot Camp, Detention, Incarceration | General disorders |
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| Overdose | General disorders |
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| Running Away | General disorders |
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| Expelled from School | General disorders |
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| Dropped Out of School | General disorders |
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| DCFS Report | General disorders | Report made to the department of children and family services (DCFS) |
|
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