Cannabis UseACTNCT07340554
Neuroimaging of Adolescent Cannabis Use Treatment
A study testing Contingency Management and Elastic Net Regression in people with Cannabis Use and Cannabis Dependence, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Cannabis Use, Cannabis Dependence, Cannabis Use Disorder
- What is being tested?
- Contingency Management and Elastic Net Regression
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Joseph Aloi, MD, PhD, 317-278-5433, liferaft@iu.edu
Katherine LeFevre, BS, 317-278-5433, liferaft@iu.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Cannabis Use, Cannabis Dependence, Cannabis Use Disorder, Cannabis Abuse, Cannabis Intoxication, Cannabis Smoking
- Being tested
- Contingency Management, Elastic Net Regression
- Keywords
- Cannabis, Marijuana, Addiction
- Medical subject headings
- Marijuana Abuse, Marijuana Smoking, Marijuana Use, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
Elastic Net RegressionDevice
We will apply an elastic net regression model to the neuroimaging data to estimate CUDIT score based on neuroimaging data.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management and Elastic Net Regression | Other | 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. Receives: Behavioral: Contingency Management; Device: Elastic Net Regression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis use frequency
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)
Measured: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis Use Disorder Identification Test (CUDIT) Score
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.
Measured: Baseline
Secondary outcomes (4)
Total quantity of cannabis use
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.
Measured: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis withdrawal
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.
Measured: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Cannabis expectancy
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.
Measured: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Proportion of negative cannabis urine drug screen
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.
Measured: Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Jun 2026
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joseph Aloi, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340554
- Sponsor's protocol ID
- 27183
- Other IDs
- K23DA063832
- Acronym
- ACT
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment
- ClinicalTrials.gov ID
- NCT07340554
- Acronym / sponsor ID
- ACT / 27183
- Conditions
- Cannabis Use, Cannabis Dependence, Cannabis Use Disorder, Cannabis Abuse, Cannabis Intoxication, Cannabis Smoking
- Keywords
- Cannabis, Marijuana, Addiction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency Management and Elastic Net Regression | Other | Behavioral: Contingency Management, Device: Elastic Net RegressionAll 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Contingency ManagementContingency 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. | Behavioural | Contingency Management and Elastic Net Regression |
| Elastic Net RegressionWe will apply an elastic net regression model to the neuroimaging data to estimate CUDIT score based on neuroimaging data. | Device | Contingency Management and Elastic Net Regression |
Primary outcome
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)
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.
4 secondary outcomes
Total quantity of cannabis use
Time frame: 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 expectancy
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management and Elastic Net Regression in people with Cannabis Use and Cannabis Dependence, run by Indiana University 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Aloi, MD, PhD (317-278-5433, liferaft@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis use frequency (time frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)). 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?
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 22 Jun 2026.