Behavioral Treatment of Adolescent Substance Use (SMART)
May 9, 2021 updated by: Alan J. Budney, Dartmouth-Hitchcock Medical Center
Behavioral Treatment of Adolescent Marijuana Use
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Mountain Manor Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 26 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)
IOP + CM + WMT
|
Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
25 computer-delivered sessions of neurocognitive training
Other Names:
|
|
Active Comparator: IOP + CM
|
Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Any Cannabis Abstinence
Time Frame: Intervention weeks 1 to 14
|
Number of participants with any cannabis abstinence during treatment
|
Intervention weeks 1 to 14
|
|
Weeks of Continuous Cannabis Abstinence
Time Frame: 14 week treatment period
|
Weeks of continuous abstinence during treatment
|
14 week treatment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Any Days of Cannabis Use
Time Frame: Intervention weeks 1 to 14
|
Number of participants with any days of cannabis use during treatment
|
Intervention weeks 1 to 14
|
|
Days of Cannabis Use
Time Frame: The intervention period between Week 1 and Week 14
|
Percent of Days Used During the Treatment Period
|
The intervention period between Week 1 and Week 14
|
|
Any Cannabis Abstinence Across Four Treatment Strategies
Time Frame: Treatment period between week 1 and week 14
|
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
Time Frame: Treatment period between week 1 and week 14
|
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence
|
Treatment period between week 1 and week 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alan J Budney, Ph.D, Dartmouth College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2013
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
August 14, 2018
Study Registration Dates
First Submitted
February 13, 2014
First Submitted That Met QC Criteria
February 13, 2014
First Posted (Estimate)
February 17, 2014
Study Record Updates
Last Update Posted (Actual)
June 4, 2021
Last Update Submitted That Met QC Criteria
May 9, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA015186-DartmouthSpectrum
- R01DA015186-12A1 (U.S. NIH Grant/Contract)
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