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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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