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Behavioral Treatment of Adolescent Substance Use

Behavioral Treatment of Adolescent Marijuana Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02063984
Acronym
SMART
Enrollment
59
Registered
2014-02-17
Start date
2013-11-30
Completion date
2018-08-14
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

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.

Interventions

BEHAVIORALIntensive 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

BEHAVIORALWorking Memory Training

25 computer-delivered sessions of neurocognitive training

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 26 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Any Cannabis AbstinenceIntervention weeks 1 to 14Number of participants with any cannabis abstinence during treatment
Weeks of Continuous Cannabis Abstinence14 week treatment periodWeeks of continuous abstinence during treatment

Secondary

MeasureTime frameDescription
Any Days of Cannabis UseIntervention weeks 1 to 14Number of participants with any days of cannabis use during treatment
Days of Cannabis UseThe intervention period between Week 1 and Week 14Percent of Days Used During the Treatment Period
Any Cannabis Abstinence Across Four Treatment StrategiesTreatment period between week 1 and week 14Number of participants who achieved at least one week of abstinence
Weeks of Cannabis Abstinence Across Four Treatment StrategiesTreatment period between week 1 and week 14Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
CM + WMT
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
29
CM + No WMT
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
30
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up65

Baseline characteristics

CharacteristicCM + WMTTotalCM + No WMT
Age, Continuous16.0 years
STANDARD_DEVIATION 1.5
16.35 years
STANDARD_DEVIATION 1.7
16.7 years
STANDARD_DEVIATION 2.1
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants5 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants54 Participants28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants45 Participants24 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants12 Participants4 Participants
Region of Enrollment
United States
29 participants59 participants30 participants
Sex: Female, Male
Female
8 Participants17 Participants9 Participants
Sex: Female, Male
Male
21 Participants42 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 290 / 30
other
Total, other adverse events
8 / 297 / 30
serious
Total, serious adverse events
0 / 290 / 30

Outcome results

Primary

Any Cannabis Abstinence

Number of participants with any cannabis abstinence during treatment

Time frame: Intervention weeks 1 to 14

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

ArmMeasureValue (NUMBER)
CM + WMTAny Cannabis Abstinence13 participants
CM + No WMTAny Cannabis Abstinence18 participants
Comparison: CM+No WMT is the comparison condition95% CI: [0.11, 1.56]
Primary

Weeks of Continuous Cannabis Abstinence

Weeks of continuous abstinence during treatment

Time frame: 14 week treatment period

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

ArmMeasureValue (MEAN)Dispersion
CM + WMTWeeks of Continuous Cannabis Abstinence7.15 Weeks of Continuous AbstinenceStandard Deviation 4.63
CM + No WMTWeeks of Continuous Cannabis Abstinence4.88 Weeks of Continuous AbstinenceStandard Deviation 4.35
Comparison: CM+No WMT is the comparison condition95% CI: [0.79, 3.07]
Secondary

Any Cannabis Abstinence Across Four Treatment Strategies

Number of participants who achieved at least one week of abstinence

Time frame: Treatment period between week 1 and week 14

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CM + WMTAny Cannabis Abstinence Across Four Treatment Strategies12 Participants
CM + No WMTAny Cannabis Abstinence Across Four Treatment Strategies12 Participants
Strategy 3Any Cannabis Abstinence Across Four Treatment Strategies14 Participants
Strategy 4Any Cannabis Abstinence Across Four Treatment Strategies11 Participants
Comparison: Strategy 1 is the comparison condition95% CI: [0.45, 2.45]
Comparison: Strategy 1 is the comparison condition95% CI: [0.84, 6.2]
Comparison: Strategy 1 is the comparison condition95% CI: [0.23, 1.13]
Secondary

Any Days of Cannabis Use

Number of participants with any days of cannabis use during treatment

Time frame: Intervention weeks 1 to 14

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CM + WMTAny Days of Cannabis Use11 Participants
CM + No WMTAny Days of Cannabis Use14 Participants
Comparison: CM+No WMT is the comparison condition95% CI: [0.18, 4.82]
Secondary

Days of Cannabis Use

Percent of Days Used During the Treatment Period

Time frame: The intervention period between Week 1 and Week 14

ArmMeasureValue (MEAN)Dispersion
CM + WMTDays of Cannabis Use32.5 percentage of days of cannabis useStandard Deviation 31
CM + No WMTDays of Cannabis Use24.5 percentage of days of cannabis useStandard Deviation 23.3
Comparison: CM+No WMT is the comparison condition95% CI: [0.33, 2.54]
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

Time frame: Treatment period between week 1 and week 14

Population: Participants with at least one week of cannabis abstinence during treatment

ArmMeasureValue (MEAN)Dispersion
CM + WMTWeeks of Cannabis Abstinence Across Four Treatment Strategies6.17 weeks of continuous abstinenceStandard Deviation 4.73
CM + No WMTWeeks of Cannabis Abstinence Across Four Treatment Strategies7.42 weeks of continuous abstinenceStandard Deviation 4.74
Strategy 3Weeks of Cannabis Abstinence Across Four Treatment Strategies5.29 weeks of continuous abstinenceStandard Deviation 4.43
Strategy 4Weeks of Cannabis Abstinence Across Four Treatment Strategies7.82 weeks of continuous abstinenceStandard Deviation 4.75
Comparison: Strategy 1 is the comparison condition95% CI: [0.76, 1.92]
Comparison: Strategy 1 is the comparison condition95% CI: [0.49, 1.18]
Comparison: Strategy 1 is the comparison condition95% CI: [0.83, 2.15]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026