SMART: Behavioral Treatment of Adolescent Substance Use

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02063984
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Mountain Manor Treatment Center (Other), University of Pennsylvania (Other), Johns Hopkins University (Other), Spectrum Youth and Family Services (Other)
• Enrollment: 59
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.4
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders	Behavioral: Intensive Outpatient Treatment (IOP) + Contingency Management (CM); Behavioral: Working Memory Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Behavioral Treatment of Adolescent Marijuana Use
• Actual Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Aug 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) IOP + CM + WMT	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; Behavioral: Working Memory Training; 25 computer-delivered sessions of neurocognitive training; Other Names: Cogmed, Inc
Active Comparator: IOP + CM IOP + CM	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

Outcome Measures

Primary Outcome Measures

1. Any Cannabis Abstinence [Intervention weeks 1 to 14]

   Number of participants with any cannabis abstinence during treatment

2. Weeks of Continuous Cannabis Abstinence [14 week treatment period]

   Weeks of continuous abstinence during treatment

Secondary Outcome Measures

1. Any Days of Cannabis Use [Intervention weeks 1 to 14]

   Number of participants with any days of cannabis use during treatment

2. Days of Cannabis Use [The intervention period between Week 1 and Week 14]

   Percent of Days Used During the Treatment Period

3. Any Cannabis Abstinence Across Four Treatment Strategies [Treatment period between week 1 and week 14]

   Number of participants who achieved at least one week of abstinence

4. Weeks of Cannabis Abstinence Across Four Treatment Strategies [Treatment period between week 1 and week 14]

   Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 26 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mountain Manor Treatment Center	Baltimore	Maryland	United States	21229

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Alan J Budney, Ph.D, Dartmouth College

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 17, 2015

More Information

Publications

None provided.

• Responsible Party: Alan J. Budney, Professor, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT02063984
• Other Study ID Numbers: DA015186-DartmouthSpectrum; R01DA015186-12A1
• First Posted: Feb 17, 2014
• Last Update Posted: Jun 4, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details	Recruited from a community intensive outpatient program from December 2015 to October 2017.

Arm/Group Title	CM + WMT	CM + No WMT
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)
Period Title: Overall Study
STARTED	29	30
COMPLETED	23	25
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	CM + WMT	CM + No WMT	Total
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)	Total of all reporting groups
Overall Participants	29	30	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.0 (1.5)	16.7 (2.1)	16.35 (1.7)
Sex: Female, Male (Count of Participants)
Female	8 27.6%	9 30%	17 28.8%
Male	21 72.4%	21 70%	42 71.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 10.3%	2 6.7%	5 8.5%
Not Hispanic or Latino	26 89.7%	28 93.3%	54 91.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	21 72.4%	24 80%	45 76.3%
White	8 27.6%	4 13.3%	12 20.3%
More than one race	0 0%	2 6.7%	2 3.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%	30 100%	59 100%

Outcome Measures

1. Primary Outcome

Title	Any Cannabis Abstinence
Description	Number of participants with any cannabis abstinence during treatment
Time Frame	Intervention weeks 1 to 14

Outcome Measure Data

Analysis Population Description

Participants who met Cannabis Use Disorder criteria, excluding those who met other drug use disorder criteria.

Arm/Group Title	CM + WMT	CM + No WMT
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)
Measure Participants	29	30
Number [participants]	13 44.8%	18 60%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	CM+No WMT is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.42
	Confidence Interval	(2-Sided) 95%; .11 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Outcome was tested in a zero-inflated negative binomial (ZINB) model

2. Primary Outcome

Title	Weeks of Continuous Cannabis Abstinence
Description	Weeks of continuous abstinence during treatment
Time Frame	14 week treatment period

Outcome Measure Data

Analysis Population Description

Calculated only for those who achieved at least one week of abstinence during the treatment period

Arm/Group Title	CM + WMT	CM + No WMT
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)
Measure Participants	13	18
Mean (Standard Deviation) [Weeks of Continuous Abstinence]	7.15 (4.63)	4.88 (4.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	CM+No WMT is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of means
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; .79 to 3.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Outcome was tested in a zero-inflated negative binomial (ZINB) model

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants with Cannabis Use Disorder and with non-missing data on 25% or more of treatment days (excluding those with other drug use disorder)

Arm/Group Title	CM + WMT	CM + No WMT
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)
Measure Participants	18	19
Count of Participants [Participants]	11 37.9%	14 46.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	CM+No WMT is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.93
	Confidence Interval	(2-Sided) 95%; .18 to 4.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CM + WMT	CM + No WMT
Arm/Group Description	Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)	Intensive Outpatient Treatment + Contingency Management (IOP + CM)
Measure Participants	11	14
Mean (Standard Deviation) [percentage of days of cannabis use]	32.5 (31.0)	24.5 (23.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	CM+No WMT is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of means
	Estimated Value	.92
	Confidence Interval	(2-Sided) 95%; .33 to 2.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	Outcome was tested in a zero-inflated negative binomial (ZINB) model

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Strategy 1	Strategy 2	Strategy 3	Strategy 4
Arm/Group Description	Start in CM stay in CM	Start in CM+WMT stay in CM+WMT	Start in CM responders stay in CM, non-responders get Enhanced CM	Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
Measure Participants	21	21	21	24
Count of Participants [Participants]	12 41.4%	12 40%	14 23.7%	11 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; .45 to 2.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, Strategy 3
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.29
	Confidence Interval	(2-Sided) 95%; .84 to 6.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, Strategy 4
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.51
	Confidence Interval	(2-Sided) 95%; .23 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants with at least one week of cannabis abstinence during treatment

Arm/Group Title	Strategy 1	Strategy 2	Strategy 3	Strategy 4
Arm/Group Description	Start in CM stay in CM	Start in CM+WMT stay in CM+WMT	Start in CM responders stay in CM, non-responders get Enhanced CM	Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
Measure Participants	12	12	14	11
Mean (Standard Deviation) [weeks of continuous abstinence]	6.17 (4.73)	7.42 (4.74)	5.29 (4.43)	7.82 (4.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, CM + No WMT
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of means
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; .76 to 1.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, Strategy 3
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of means
	Estimated Value	.76
	Confidence Interval	(2-Sided) 95%; .49 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CM + WMT, Strategy 4
	Comments	Strategy 1 is the comparison condition
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of means
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; .83 to 2.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
Arm/Group Title	Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)		IOP + CM
Arm/Group Description	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		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
All Cause Mortality
	Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)		IOP + CM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/29 (6.9%)		0/30 (0%)
Serious Adverse Events
	Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)		IOP + CM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)		IOP + CM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/29 (27.6%)		7/30 (23.3%)
Metabolism and nutrition disorders
Dehydration	1/29 (3.4%)	1	0/30 (0%)	0
Nervous system disorders
Loss of consciousness	0/29 (0%)	0	1/30 (3.3%)	1
Psychiatric disorders
Overdose	2/29 (6.9%)	2	0/30 (0%)	0
Suicidal ideation without a plan	0/29 (0%)	0	1/30 (3.3%)	1
Suicide attempt	1/29 (3.4%)	1	0/30 (0%)	0
Drug induced psychosis	0/29 (0%)	0	1/30 (3.3%)	1
Social circumstances
Incarceration	3/29 (10.3%)	3	4/30 (13.3%)	4
Arrest	1/29 (3.4%)	1	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.