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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA023526-01 | U.S. NIH Grant/Contract | View source | |
| 1R01DA023526-02 | U.S. NIH Grant/Contract | View source | |
| 1R01DA023526-03 | U.S. NIH Grant/Contract | View source |
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More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. This application seeks to advance the overarching goal to develop and disseminate cost-effective treatments for marijuana dependence that can address this growing problem.
The researchers' previous research suggests that an intervention comprising motivational enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM) produces greater rates of successful and durable outcomes than has been demonstrated previously. However, three issues relevant to its efficacy and eventual dissemination must be confronted. First, the outcomes achieved can only be characterized as modest; many individuals do not respond to the treatment and relapse rates remain problematic. Second, access is limited by the availability of trained providers. Third, the cost of delivering the treatment is higher than more traditional outpatient interventions.
To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of treatment services by increasing availability of and access to potent treatments, and by applying innovative technology to enhance outcomes. During Year 1, the intervention will be developed and pilot tested. An interactive program that showed promise in a previous trial for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM using effective computer learning technologies. These technologies and access to the MET/CBT/CM program made available via the Internet between treatment sessions and after treatment ends have the potential to promote better learning and more use of coping skills, which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental design will provide a unique opportunity to explore such mechanisms in a novel context- where the therapist is vs. is not a prominent part of the treatment.
The proposed project will address the objectives of NIDA's Behavioral and Integrative Treatment Development Program by providing research on technology-assisted treatment that attempts to make treatment delivery less complex, easier to access, and less costly - while retaining or improving its effectiveness. Findings will inform future studies designed to refine the technology and how it is applied; conduct more definitive effectiveness testing; test generality to other populations including adolescents; and to further advance translation to community settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Therapist delivered cognitive behavioral treatment |
|
| 2 | Experimental | Computerized Cognitive Behavioral treatment |
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| 3 | Active Comparator | Motivational enhancement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Nine session treatment |
| |
| Computerized Psychotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Consecutive Weeks of Marijuana Abstinence | Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report. | From the start of treatment through the end of the active treatment period, i.e., 12 weeks. |
| Point Prevalence Abstinence Post Treatment | Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment). | 9 months (from the end of treatment to 9 months post-treatment). |
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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 |
Participants were excluded from trial prior to group assignment for at least one of the following:no evidence of marijuana use in at least 40 of the past 90 days prior to enrollment,participant met criteria for dependence on alcohol or illicit drugs,evidence of illicit drug use or K-2 use,interfering medical/psychiatric illness,or active refusal.
Recruitment opened in November 2008 and closed in May 2011. Recruitment practices included newspaper and radio advertisements, flyers, and posters distributed in local businesses and agencies. The study took place at an outpatient psychiatry clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-MET/CBT/CM | Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM) Psychotherapy : Nine session treatment (wks 1-8 and wk 12) 2x/wk urine drug testing Contingency Management voucher program |
| FG001 | 2-cMET/CBT/CM | Computer-delievered (c) MET/CBT/CM treatment Computerized Psychotherapy : Nine session computer delivered treatment 2 times per week urine drug testing |
| FG002 | 3-tMET | Motivational enhancement therapy Motivational enhancement therapy : Two session treatment 2x/wk urine drug testing non-contingent vouchers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-MET/CBT/CM | Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM) Nine weekly therapy sessions delivered in weeks 1-8 and week 12 2 times per week urine drug testing Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test. |
| 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 | Consecutive Weeks of Marijuana Abstinence | Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report. | Intent to Treat | Posted | Mean | Standard Deviation | consecutive weeks of abstinence | From the start of treatment through the end of the active treatment period, i.e., 12 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 | 1-MET/CBT/CM | Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM) Psychotherapy : Nine session treatment (wks 1-8 and wk 12) 2x/wk urine drug testing Contingency Management voucher program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan J. Budney, PhD Principal Investigator | Geisel School of Medicine at Dartmouth College | 855-290-2822 | Alan.J.Budney@dartmouth.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
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| Behavioral |
Nine session computer delivered treatment |
|
| Motivational enhancement therapy | Behavioral | Two session treatment |
|
| BG001 | 2-cMET/CBT/CM | Computer-delievered (c) MET/CBT/CM treatment Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12. 2 times per week urine drug testing. Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test. |
| BG002 | 3-tMET | Therapist delivered motivational enhancement therapy (tMET) Two session treatment with sessions delivered during weeks 1 and 4. Two times per week urine drug testing. Non-contingent incentives delivered for attending each urine testing appointment. |
| 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 |
|
| Point prevalence abstinence | Total percentage column is not accurate because it is automatically summed, which results in an invalid number. | Number | percentage of participants |
|
| OG002 | 3-tMET | Motivational enhancement therapy Motivational enhancement therapy : Two session treatment |
|
|
|
| Primary | Point Prevalence Abstinence Post Treatment | Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment). | Intent to Treat | Posted | Number | pecentage of participants abstinent | 9 months (from the end of treatment to 9 months post-treatment). |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 2-cMET/CBT/CM | Computer-delievered (c) MET/CBT/CM treatment Computerized Psychotherapy : Nine session computer delivered treatment 2 times per week urine drug testing | 0 | 30 | 0 | 30 |
| EG002 | 3-tMET | Motivational enhancement therapy Motivational enhancement therapy : Two session treatment 2x/wk urine drug testing non-contingent vouchers | 0 | 16 | 0 | 16 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
|
| 6-months Post Treatment Abstinence Rate |
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| 9-months Post Treatment Abstinence Rate |
|