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

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:
  • Cogmed, Inc
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.

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

Other Study ID Numbers

  • DA015186-DartmouthSpectrum
  • R01DA015186-12A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Intensive Outpatient Treatment (IOP) + Contingency Management (CM)

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