Adolescent DevelopmentMIDNCT06369623
Monetary Incentive Delay Task for Probing Reward-related Neural Processes
A study testing Monetary Incentive Delay Task in people with Adolescent Development, run by Stony Brook University at 1 site in United States.
Trial summary
150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development
- What is being tested?
- Monetary Incentive Delay Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2024to 30 Nov 2028
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Males and females ages 14-17 years-old;
- English-speaking for assent and interview completion;
- Capacity to provide assent.
- For parents, the inclusion criteria will be willing and capacity to provide parental permission/consent.
Who cannot join
- current (within 6 months) use of medication that may affect cerebral function
- history of severe medical or neurological illness, including stroke or seizure;
- history of head trauma with loss of consciousness;
- presence of metal in the body;
- pregnancy or breastfeeding;
- recent drug or alcohol use determined by positive urine toxicology or breathalyzer (to validate self-report assessment of substance use history);
- lifetime use of psychotropic or other medication that could likely influence dopamine function, namely stimulant medication or antipsychotic medication, except a subgroup of 25 youth with history of prescribed stimulant medication and a subgroup of 15 youth with history antipsychotic medication will be enrolled for comparison purposes.
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
Stony Brook Medicine
Stony Brook, New York, 11794
Greg Perlman, PhD, 631-638-1922, greg.perlman@stonybrookmedicine.edu
Roman Kotov, PhD
About this study
Official title: Neuromelanin MRI: A Tool for Non-invasive Investigation of Dopaminergic Abnormalities in Adolescent Substance Use
150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months.
Read the detailed description
Substance use disorders affect several million people in the United States every year, create significant economic burden, and cause tremendous suffering at the person, family, and societal levels. This proposal aims to investigate the dynamic interplay between pediatric substance use (a risk factor for substance use disorders) and rate of neuromelanin accumulation (a proxy for dopamine function) for the first time. Thus, this research seeks to identify a brain mechanism (dopamine function) that could be targeted in youth by future treatments in order to prevent onset of substance use disorders.
The goals of this study require a prospective imaging design that relies on the naturally-occurring adolescent substance use (e.g., differences in timing and amount of substance use is treated as quasi-experimental). Importantly, the investigators will begin data collection in a cohort on the cusp of entering a high-risk period of substance use initiation and conclude data collection after 36-months to capture substance use escalation. An intermediate 18-month follow-up NM-MRI scan is needed to help clarify the magnitude of early changes in NM accumulation. Thus, this is a longitudinal, observational study.
Of note, the use of the Monetary Incentive Delay fMRI task at baseline, 18-month, and 36-month follow-ups fulfills the NIH criteria of a basic experimental studies involving humans (BESH). Thus, this study as a whole qualifies as a clinical trial based on the determination:
- The study involves humans
- The participants are prospectively assigned to an intervention, which in this case means that the subject will be assigned to complete the Monetary Incentive Delay fMRI task while lying in the MRI scanner.
- The study is designed to evaluate the effect of the intervention on participants, which in this case means that the investigators will evaluate the effect of the Monetary Incentive Delay task on brain activation in participants.
- The effect being evaluated is a health-related biomedical or behavioral outcome, which in this case means fMRI brain activation between win and loss conditions, as well as between phases of anticipation and consummation/outcome.
In brief, use of this fMRI task is a single arm, non-masked, non-randomized, basic science intervention. This does not match any of the NIH-defined clinical trials phases (n/a). The fMRI data (brain activation) is the primary outcome measure of the BESH intervention, but is a tertiary outcome in the context of this longitudinal study. The task is utilized for its short-lived, reversible, and benign effects (e.g., brief changes in brain activation).
- Conditions
- Adolescent Development
- Being tested
- Monetary Incentive Delay Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monetary Incentive Delay TaskOther
The Monetary Incentive Delay functional Magnetic Resonance Imaging task is well-characterized and commonly utilized in research settings to measure neural activation between win and loss conditions, as well as between phases of anticipation and consummation/outcome. A recent meta-analysis indicates that the task has been used in over 80 studies and 5,000 subjects as of Year 2022. The task is also valid and appropriate for use in children and adolescents, as demonstrated by its inclusion in National Institute on Drug Abuse ABCD study. The task is utilized for its short-lived, reversible, and/or benign effects on brain activation (e.g., brief processing of a reward cue).
| Study group | Role | What they receive |
|---|---|---|
| Whole sample | Experimental | All enrolled subjects will complete a standard Monetary Incentive Delay Task if able. Inclusion of this task meets criteria for Basic Experimental Studies Involving Humans (BESH) Receives: Other: Monetary Incentive Delay Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Brain Activation (BOLD Signal) during Monetary Incentive Delay Task by Condition
fMRI activation during task during win, loss, and no change conditions, as well as anticipation and consummation phases.
Measured: Baseline, 18-month, 36-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start6 Apr 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Perlman, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369623
- Sponsor's protocol ID
- IRB2023-00466
- Acronym
- MID
- Status last verified
- May 2025
- First submitted
- 13 Apr 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromelanin MRI: A Tool for Non-invasive Investigation of Dopaminergic Abnormalities in Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT06369623
- Acronym / sponsor ID
- MID / IRB2023-00466
- Conditions
- Adolescent Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 17 Apr 2024 (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.
150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months.
Detailed description
Substance use disorders affect several million people in the United States every year, create significant economic burden, and cause tremendous suffering at the person, family, and societal levels. This proposal aims to investigate the dynamic interplay between pediatric substance use (a risk factor for substance use disorders) and rate of neuromelanin accumulation (a proxy for dopamine function) for the first time. Thus, this research seeks to identify a brain mechanism (dopamine function) that could be targeted in youth by future treatments in order to prevent onset of substance use disorders.
The goals of this study require a prospective imaging design that relies on the naturally-occurring adolescent substance use (e.g., differences in timing and amount of substance use is treated as quasi-experimental). Importantly, the investigators will begin data collection in a cohort on the cusp of entering a high-risk period of substance use initiation and conclude data collection after 36-months to capture substance use escalation. An intermediate 18-month follow-up NM-MRI scan is needed to help clarify the magnitude of early changes in NM accumulation. Thus, this is a longitudinal, observational study.
Of note, the use of the Monetary Incentive Delay fMRI task at baseline, 18-month, and 36-month follow-ups fulfills the NIH criteria of a basic experimental studies involving humans (BESH). Thus, this study as a whole qualifies as a clinical trial based on the determination:
- The study involves humans
- The participants are prospectively assigned to an intervention, which in this case means that the subject will be assigned to complete the Monetary Incentive Delay fMRI task while lying in the MRI scanner.
- The study is designed to evaluate the effect of the intervention on participants, which in this case means that the investigators will evaluate the effect of the Monetary Incentive Delay task on brain activation in participants.
- The effect being evaluated is a health-related biomedical or behavioral outcome, which in this case means fMRI brain activation between win and loss conditions, as well as between phases of anticipation and consummation/outcome.
In brief, use of this fMRI task is a single arm, non-masked, non-randomized, basic science intervention. This does not match any of the NIH-defined clinical trials phases (n/a). The fMRI data (brain activation) is the primary outcome measure of the BESH intervention, but is a tertiary outcome in the context of this longitudinal study. The task is utilized for its short-lived, reversible, and benign effects (e.g., brief changes in brain activation).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole sample | Experimental | Other: Monetary Incentive Delay TaskAll enrolled subjects will complete a standard Monetary Incentive Delay Task if able. Inclusion of this task meets criteria for Basic Experimental Studies Involving Humans (BESH) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females ages 14-17 years-old;
- English-speaking for assent and interview completion;
- Capacity to provide assent.
- For parents, the inclusion criteria will be willing and capacity to provide parental permission/consent.
Key exclusion criteria (7 listed)
- current (within 6 months) use of medication that may affect cerebral function
- history of severe medical or neurological illness, including stroke or seizure;
- history of head trauma with loss of consciousness;
- presence of metal in the body;
- pregnancy or breastfeeding;
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 |
|---|---|---|
| Monetary Incentive Delay TaskThe Monetary Incentive Delay functional Magnetic Resonance Imaging task is well-characterized and commonly utilized in research settings to measure neural activation between win and loss conditions, as well as between phases of anticipation and consummation/outcome. A recent meta-analysis indicates that the task has been used in over 80 studies and 5,000 subjects as of Year 2022. The task is also valid and appropriate for use in children and adolescents, as demonstrated by its inclusion in National Institute on Drug Abuse ABCD study. The task is utilized for its short-lived, reversible, and/or benign effects on brain activation (e.g., brief processing of a reward cue). | Other | Whole sample |
Primary outcome
Amount of Brain Activation (BOLD Signal) during Monetary Incentive Delay Task by Condition
Time frame: Baseline, 18-month, 36-month.
fMRI activation during task during win, loss, and no change conditions, as well as anticipation and consummation phases.
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 15 May 2025.
- Individual participant dataSharing planned: No
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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 Monetary Incentive Delay Task in people with Adolescent Development, run by Stony Brook 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 7 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 15 May 2025. 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 Greg Perlman, PhD (1-631-638-1922, greg.perlman@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Brain Activation (BOLD Signal) during Monetary Incentive Delay Task by Condition (time frame: Baseline, 18-month, 36-month.). 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 15 May 2025.