Behavioral Treatment of Adolescent Substance Use

Substance Use Disorders Clinical Trial

— SMART  

Official title:

Behavioral Treatment of Adolescent Marijuana Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063984
• Other study ID #: DA015186-DartmouthSpectrum
• Secondary ID: R01DA015186-12A1
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 14, 2018

Study information

• Verified date: May 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 14, 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Mountain Manor Treatment Center	Baltimore	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Johns Hopkins University, Mountain Manor Treatment Center, National Institute on Drug Abuse (NIDA), Spectrum Youth and Family Services, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Cannabis Abstinence	Number of participants with any cannabis abstinence during treatment	Intervention weeks 1 to 14
Primary	Weeks of Continuous Cannabis Abstinence	Weeks of continuous abstinence during treatment	14 week treatment period
Secondary	Any Days of Cannabis Use	Number of participants with any days of cannabis use during treatment	Intervention weeks 1 to 14
Secondary	Days of Cannabis Use	Percent of Days Used During the Treatment Period	The intervention period between Week 1 and Week 14
Secondary	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
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	Treatment period between week 1 and week 14