Neuroimaging of Adolescent Cannabis Use Treatment (ACT)

April 30, 2026 updated by: Joseph Aloi, Indiana University

Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 13-week clinical trial to examine whether success during contingency management treatment for cannabis use is associated with baseline functioning of instrumental learning neuro-circuitries. The investigators propose to recruit N=80 youths ages 14-17 with varying levels of cannabis use. Following phone prescreening, participants will undergo informed consent/assent and eligibility assessment with an in-person visit. Participants who are eligible will undergo a functional magnetic resonance imaging (fMRI) scan where participants will perform an instrumental learning task during a second in-person visit. At this visit, participants and participants' guardians or most recent caregiver will be provided with ten urine drug screens. A tutorial will be provided by study staff on how to administer and read urine drug screens. After the fMRI scan, participants will undergo ten weekly virtual contingency management sessions administered via HIPAA-compliant telehealth software (e.g., Microsoft Teams). At each contingency management (CM) session, participants will be asked to provide a urine sample, and participants' guardians will be asked to administer the urine drug screen based on this sample. At each contingency management session, the timeline followback will be used to assess which days since the last session participants used cannabis at all. Finally, at each contingency management session, participants will answer brief questionnaires regarding participants' current cannabis cravings and cannabis withdrawal symptoms. For the first two sessions, participants will be able to spin a virtual wheel to win prizes (either positive affirmations or amazon gift cards in varying amounts from $5-$100) for producing a urine drug screen and answering the questions. For sessions 3-10, participants will spin the virtual wheel to win prizes after producing a urine drug screen that is negative for cannabinoids and reporting that they have not used cannabis since the last session. After the ten weekly contingency management sessions, participants will return for an in-person visit where participants will answer questions regarding their cannabis use disorder symptoms during the contingency management treatment and readiness to change. The investigators' specific aims are to identify associations between baseline Cannabis Use Disorder (CUD) symptom levels and neural activity during instrumental learning in cannabis-using adolescents (Aim 1) and Identify associations between neural activity during instrumental learning and reductions in cannabis use frequency during contingency management (Aim 2).

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joseph Aloi, MD, PhD
  • Phone Number: 317-278-5433
  • Email: liferaft@iu.edu

Study Contact Backup

  • Name: Katherine LeFevre, BS
  • Phone Number: 317-278-5433
  • Email: liferaft@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 14-17 year old youth
  • Guardian 18 years or older
  • Youth is MRI-eligible: No metal implants, prosthetics, orthodontic devices, transdermal medication patches, piercings and/or hair or eyelash extensions that cannot easily be removed, metallic ink tattoos on the neck or face, or claustrophobia, and are not pregnant
  • Youth must endorse having used cannabis at least once per week over the past month OR youth must have been diagnosed with cannabis use disorder within the past three months

Exclusion Criteria:

  • Youth has a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent/guardian report
  • Youth or caretaker who is monolingual non-English speaker
  • Youth who is currently experiencing active psychosis symptoms or suicidal/homicidal ideation or who has been hospitalized within the past 6 months for psychosis or suicidality/homicidality
  • Youth who is currently undergoing contingency management treatment for cannabis use disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Contingency Management and Elastic Net Regression

All participants will receive Contingency Management treatment for Cannabis Use.

An elastic net regression model will be applied to the neuroimaging data for all participants to estimate scores on the CUDIT.
Behavioral: Contingency Management
Contingency management is an evidence-based behavioral intervention used to treat substance use disorders, including cannabis use disorder (CUD). Contingency management operates on the principles of instrumental learning, where positive reinforcement is used to encourage desired behaviors, such as abstinence from cannabis. First, specific target behaviors are identified for reinforcement. In CUD, this is often abstinence from cannabis use, verified through regular urine drug screens and self-reports. If the target behavior (i.e., abstaining from cannabis for a specified time period) is achieved, then patients receive tangible rewards immediately after attaining the target behavior. These rewards are often in the form of money, vouchers, or other incentives that are meaningful to the individual. We will examine whether success during contingency management treatment for cannabis use is associated with neural activity during instrumental learning in N=80 adolescents ages 14-17.
Device: Elastic Net Regression
We will apply an elastic net regression model to the neuroimaging data to estimate CUDIT score based on neuroimaging data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis Use Disorder Identification Test (CUDIT) Score
Time Frame: Baseline
The CUDIT (Adamson et al., 2010) is a measure of cannabis use disorder symptom level. This scale is an 8-item scale that asks about cannabis use disorder symptoms over the past year and is scored on a scale of 0 (no cannabis use in the past year) to 32 (daily cannabis use, physical and psychological dependence symptoms, severe cannabis misuse). The CUDIT will be measured once at the baseline screening visit.
Baseline
Cannabis use frequency
Time Frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
The investigators will measure cannabis use frequency via percent of days where cannabis was used over the past 30 days via the Timeline Followback Scale (Sobell and Sobell, 1992)
Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total quantity of cannabis use
Time Frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
The investigators will measure cannabis use quantity via the Timeline Followback Scale (Sobell and Sobell, 1992). For each day participants report cannabis use on the Timeline Followback Scale, participants will be asked to estimate the number of grams of cannabis used.
Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis withdrawal
Time Frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis withdrawal will be measured at 12 different time points via the Cannabis Withdrawal Scale (Milin, Manion, Dare, and Walker, 2008). The Cannabis Withdrawal Scale is a 16-item scale that evaluates cannabis withdrawal symptoms, such as sleep difficulties, nervousness, anxiety, tension, and cravings for cannabis. This scale will be administered at the scanning visit, each of the 10 contingency management visits, and at the follow-up visit.
Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis expectancy
Time Frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis expectancy will be measured at 2 time points via the Marijuana Effects Expectancy Scale-Brief (Torrealday et al., 2008). The Marijuana Effects Expectancy Scale-Brief is a six item scale that measures expected effects (relaxation, reduced anxiety, cravings) of marijuana use. This scale will be administered at the scanning visit and the follow-up visit.
Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Proportion of negative cannabis urine drug screen
Time Frame: Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Urine drug screens will be collected at each visit (13 total). The investigators will track the proportion of urine drug screens that are negative over all visits and that are negative over the 10 contingency management visits.
Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27183
  • K23DA063832 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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