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Behavioral Treatment of Adolescent Substance Use (SMART)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Outpatient Treatment (IOP) + Contingency Management (CM)
Working Memory Training
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

12 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mountain Manor Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)

IOP + CM

Arm Description

IOP + CM + WMT

IOP + CM

Outcomes

Primary Outcome Measures

Any Cannabis Abstinence
Number of participants with any cannabis abstinence during treatment
Weeks of Continuous Cannabis Abstinence
Weeks of continuous abstinence during treatment

Secondary Outcome Measures

Any Days of Cannabis Use
Number of participants with any days of cannabis use during treatment
Days of Cannabis Use
Percent of Days Used During the Treatment Period
Any Cannabis Abstinence Across Four Treatment Strategies
Number of participants who achieved at least one week of abstinence
Weeks of Cannabis Abstinence Across Four Treatment Strategies
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence

Full Information

First Posted
February 13, 2014
Last Updated
May 9, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), Mountain Manor Treatment Center, University of Pennsylvania, Johns Hopkins University, Spectrum Youth and Family Services
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1. Study Identification

Unique Protocol Identification Number
NCT02063984
Brief Title
Behavioral Treatment of Adolescent Substance Use
Acronym
SMART
Official Title
Behavioral Treatment of Adolescent Marijuana Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), Mountain Manor Treatment Center, University of Pennsylvania, Johns Hopkins University, Spectrum Youth and Family Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)
Arm Type
Experimental
Arm Description
IOP + CM + WMT
Arm Title
IOP + CM
Arm Type
Active Comparator
Arm Description
IOP + CM
Intervention Type
Behavioral
Intervention Name(s)
Intensive Outpatient Treatment (IOP) + Contingency Management (CM)
Intervention Description
Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
Intervention Type
Behavioral
Intervention Name(s)
Working Memory Training
Other Intervention Name(s)
Cogmed, Inc
Intervention Description
25 computer-delivered sessions of neurocognitive training
Primary Outcome Measure Information:
Title
Any Cannabis Abstinence
Description
Number of participants with any cannabis abstinence during treatment
Time Frame
Intervention weeks 1 to 14
Title
Weeks of Continuous Cannabis Abstinence
Description
Weeks of continuous abstinence during treatment
Time Frame
14 week treatment period
Secondary Outcome Measure Information:
Title
Any Days of Cannabis Use
Description
Number of participants with any days of cannabis use during treatment
Time Frame
Intervention weeks 1 to 14
Title
Days of Cannabis Use
Description
Percent of Days Used During the Treatment Period
Time Frame
The intervention period between Week 1 and Week 14
Title
Any Cannabis Abstinence Across Four Treatment Strategies
Description
Number of participants who achieved at least one week of abstinence
Time Frame
Treatment period between week 1 and week 14
Title
Weeks of Cannabis Abstinence Across Four Treatment Strategies
Description
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence
Time Frame
Treatment period between week 1 and week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Budney, Ph.D
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Manor Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31246068
Citation
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.
Results Reference
result

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Behavioral Treatment of Adolescent Substance Use

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