Substance Use DisordersSMARTNCT02063984
Behavioral Treatment of Adolescent Substance Use
A study testing Intensive Outpatient Treatment (IOP) + Contingency Management (CM) and Working Memory Training in people with Substance Use Disorders, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 26 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Intensive Outpatient Treatment (IOP) + Contingency Management (CM) and Working Memory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Intensive Outpatient Treatment (IOP) + Contingency Management (CM), Working Memory Training
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Outpatient Treatment (IOP) + Contingency Management (CM)Behavioural
Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
Working Memory TrainingBehavioural
Also called Cogmed, Inc
25 computer-delivered sessions of neurocognitive training
| Study group | Role | What they receive |
|---|---|---|
| Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) | Experimental | IOP + CM + WMT Receives: Behavioral: Intensive Outpatient Treatment (IOP) + Contingency Management (CM); Behavioral: Working Memory Training |
| IOP + CM | Active comparator | IOP + CM Receives: Behavioral: Intensive Outpatient Treatment (IOP) + Contingency Management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Cannabis Abstinence
Number of participants with any cannabis abstinence during treatment
Measured: Intervention weeks 1 to 14
Weeks of Continuous Cannabis Abstinence
Weeks of continuous abstinence during treatment
Measured: 14 week treatment period
Secondary outcomes (4)
Any Days of Cannabis Use
Number of participants with any days of cannabis use during treatment
Measured: Intervention weeks 1 to 14
Days of Cannabis Use
Percent of Days Used During the Treatment Period
Measured: The intervention period between Week 1 and Week 14
Any Cannabis Abstinence Across Four Treatment Strategies
Number of participants who achieved at least one week of abstinence
Measured: Treatment period between week 1 and week 14
Weeks of Cannabis Abstinence Across Four Treatment Strategies
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence
Measured: Treatment period between week 1 and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mountain Manor Treatment Center, University of Pennsylvania, Johns Hopkins University, Spectrum Youth and Family Services
- Responsible party
- Principal investigator, Alan J. Budney, Dartmouth-Hitchcock Medical Center
- Investigators
- Alan J Budney, Ph.D, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063984
- Sponsor's protocol ID
- DA015186-DartmouthSpectrum
- Other IDs
- R01DA015186-12A1
- Acronym
- SMART
- Status last verified
- May 2021
- First submitted
- 13 Feb 2014
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31246068
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Adolescent Marijuana Use
- ClinicalTrials.gov ID
- NCT02063984
- Acronym / sponsor ID
- SMART / DA015186-DartmouthSpectrum
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mountain Manor Treatment Center, University of Pennsylvania, Johns Hopkins University, Spectrum Youth and Family Services
- Study start
- Nov 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) | Experimental | Behavioral: Intensive Outpatient Treatment (IOP) + Contingency Management (CM), Behavioral: Working Memory TrainingIOP + CM + WMT |
| IOP + CM | Active comparator | Behavioral: Intensive Outpatient Treatment (IOP) + Contingency Management (CM)IOP + CM |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | IOP + CM, Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) |
| Working Memory TrainingAlso: Cogmed, Inc25 computer-delivered sessions of neurocognitive training | Behavioural | Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT) |
Primary outcome
Any Cannabis Abstinence
Time frame: Intervention weeks 1 to 14
Number of participants with any cannabis abstinence during treatment
Weeks of Continuous Cannabis Abstinence
Time frame: 14 week treatment period
Weeks of continuous abstinence during treatment
4 secondary outcomes
Any Days of Cannabis Use
Time frame: Intervention weeks 1 to 14
Days of Cannabis Use
Time frame: 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
Weeks of Cannabis Abstinence Across Four Treatment Strategies
Time frame: Treatment period between week 1 and week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31246068Stanger 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.
Related trials for Substance Use Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan J Budney, Ph.D principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Outpatient Treatment (IOP) + Contingency Management (CM) and Working Memory Training in people with Substance Use Disorders, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Cannabis Abstinence (time frame: Intervention weeks 1 to 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.