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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA015186-12A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Mountain Manor Treatment Center | OTHER |
| University of Pennsylvania | OTHER |
| Johns Hopkins University |
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This study will continue research designed to improve treatment outcomes for adolescent substance use disorders by integrating neuroscience- and behaviorally-based treatments. In particular, this project will be the first to evaluate whether Working Memory Training can enhance cognitive function and reduce impulsive decision making to improve abstinence outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a new method for intervening with those who do not respond to their first-line treatment.
The study will test two novel strategies to enhance outcomes. Working Memory Training (WMT), an efficacious method for strengthening specific cognitive processes, aims to improve factors (e.g., delay discounting / impulsive decision-making) that have shown a strong relation to substance use and treatment response. Second, more intensive and higher magnitude CM (ICM) will be used to motivate abstinence among teens who are not abstinent by Week 4. The investigators hypothesize that these strategies will improve outcomes by modifying a fundamental cognitive system involved in making choices to engage in risky behavior and by increasing motivation to abstain in early nonresponders. Aim 1 will pilot and refine the new procedures in a community clinic in preparation for the randomized trial. A sequential, multiple assignment randomized trial (SMART) will allow the study to determine the most effective first-line treatment and the most effective adaptive strategy (Aim 2). All teens will begin treatment with CM or CM/WMT. After 4 weeks, responders will continue in their first-line treatments, while nonresponders will be randomized to ICM or to continue with first-line treatment. Aim 3 will conduct mechanistic analyses to assess whether cognitive changes related to WMT engender increased abstinence, and whether specific tailoring variables moderate treatment effects. Aim 4 will gather formative data on implementation factors to inform future large-scale studies and dissemination efforts. Primary hypotheses are: (1) first-line treatment with WMT will improve abstinence outcomes and reduce relapse; (2) strategies with ICM for nonresponders will result in better outcomes than those without; (3) WMT will reduce delay discounting, which will predict outcome. The unique approach holds promise for reducing multiple types of risky behaviors by affecting basic mechanisms that determine impulsive decision-making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) | Experimental | IOP + CM + WMT |
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| IOP + CM | Active Comparator | IOP + CM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Outpatient Treatment (IOP) + Contingency Management (CM) | Behavioral | Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives |
| Measure | Description | Time Frame |
|---|---|---|
| Any Cannabis Abstinence | Number of participants with any cannabis abstinence during treatment | Intervention weeks 1 to 14 |
| Weeks of Continuous Cannabis Abstinence | Weeks of continuous abstinence during treatment | 14 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Any Days of Cannabis Use | Number of participants with any days of cannabis use during treatment | Intervention weeks 1 to 14 |
| Days of Cannabis Use | Percent of Days Used During the Treatment Period |
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Inclusion Criteria:
Participants must be 12 to 26 years of age, must live at home with the parent who will participate, report using marijuana during the previous 30 days or provide a marijuana-positive urine test, meet criteria for cannabis abuse or dependence, and have a parent who can participate.
Exclusion Criteria: DSM criteria for dependence (likely to be adjusted for DSM-5 Use Disorder) on alcohol or other drugs other than marijuana (use of or meeting criteria for abuse of other substances will not be an exclusion criterion), active psychosis, severe medical or psychiatric illness limiting participation, or pregnant or breast-feeding.
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Budney, Ph.D | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Manor Treatment Center | Baltimore | Maryland | 21229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31246068 | Result | Stanger C, Scherer EA, Vo HT, Babbin SF, Knapp AA, McKay JR, Budney AJ. Working memory training and high magnitude incentives for youth cannabis use: A SMART pilot trial. Psychol Addict Behav. 2020 Feb;34(1):31-39. doi: 10.1037/adb0000480. Epub 2019 Jun 27. |
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Recruited from a community intensive outpatient program from December 2015 to October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | CM + WMT | Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT) |
| FG001 | CM + No WMT | Intensive Outpatient Treatment + Contingency Management (IOP + CM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CM + WMT | Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT) |
| BG001 | CM + No WMT | Intensive Outpatient Treatment + Contingency Management (IOP + CM) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Any Cannabis Abstinence | Number of participants with any cannabis abstinence during treatment | Participants who met Cannabis Use Disorder criteria, excluding those who met other drug use disorder criteria. | Posted | Number | participants | Intervention weeks 1 to 14 |
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Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
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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 | Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) | IOP + CM + WMT Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives Working Memory Training: 25 computer-delivered sessions of neurocognitive training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan J. Budney, Ph.D | Geisel School of Medicine at Dartmouth Center for Technology and Behavioral Health | 603-646-7088 | alan.budney@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2015 | Apr 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| Spectrum Youth and Family Services | OTHER |
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| Working Memory Training | Behavioral | 25 computer-delivered sessions of neurocognitive training |
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| The intervention period between Week 1 and Week 14 |
| Any Cannabis Abstinence Across Four Treatment Strategies | Number of participants who achieved at least one week of abstinence | Treatment period between week 1 and week 14 |
| Weeks of Cannabis Abstinence Across Four Treatment Strategies | Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence | Treatment period between week 1 and week 14 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Weeks of Continuous Cannabis Abstinence | Weeks of continuous abstinence during treatment | Calculated only for those who achieved at least one week of abstinence during the treatment period | Posted | Mean | Standard Deviation | Weeks of Continuous Abstinence | 14 week treatment period |
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| Secondary | Any Days of Cannabis Use | Number of participants with any days of cannabis use during treatment | Participants with Cannabis Use Disorder and with non-missing data on 25% or more of treatment days (excluding those with other drug use disorder) | Posted | Count of Participants | Participants | Intervention weeks 1 to 14 |
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| Secondary | Days of Cannabis Use | Percent of Days Used During the Treatment Period | Posted | Mean | Standard Deviation | percentage of days of cannabis use | The intervention period between Week 1 and Week 14 |
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| Secondary | Any Cannabis Abstinence Across Four Treatment Strategies | Number of participants who achieved at least one week of abstinence | Ns in each strategy are the sum of [1] dropouts in the phase 1 condition, [2] responders in the phase 1 condition; and [3] nonresponders in the phase 1 condition who are assigned to the specified phase 2 condition. These ns for each strategy are: [1] 5+8+8=21; [2] 6+10+5=21; [3] 5+8+8=21; [4] 6+10+8=24. | Posted | Count of Participants | Participants | Treatment period between week 1 and week 14 |
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| Secondary | Weeks of Cannabis Abstinence Across Four Treatment Strategies | Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence | Participants with at least one week of cannabis abstinence during treatment | Posted | Mean | Standard Deviation | weeks of continuous abstinence | Treatment period between week 1 and week 14 |
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| 2 |
| 29 |
| 0 |
| 29 |
| 8 |
| 29 |
| EG001 | IOP + CM | IOP + CM Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives | 0 | 30 | 0 | 30 | 7 | 30 |
| Suicidal ideation without a plan | Psychiatric disorders | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
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| Incarceration | Social circumstances | Non-systematic Assessment |
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| Arrest | Social circumstances | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Drug induced psychosis | Psychiatric disorders | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | Non-systematic Assessment |
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| Odds Ratio (OR) |
| 2.29 |
| 2-Sided |
| 95 |
| .84 |
| 6.20 |
| Superiority |
| Strategy 1 is the comparison condition | Odds Ratio (OR) | .51 | 2-Sided | 95 | .23 | 1.13 | Superiority |
| Ratio of means |
| .76 |
| 2-Sided |
| 95 |
| .49 |
| 1.18 |
| Superiority |
| Strategy 1 is the comparison condition | Ratio of means | 1.33 | 2-Sided | 95 | .83 | 2.15 | Superiority |