Monetary Incentive Delay Task for Probing Reward-related Neural Processes
MID
Neuromelanin MRI: A Tool for Non-invasive Investigation of Dopaminergic Abnormalities in Adolescent Substance Use
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2024
CompletedFirst Submitted
Initial submission to the registry
April 13, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
May 15, 2025
May 1, 2025
4.7 years
April 13, 2024
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 18-month, 36-month.
Study Arms (1)
Whole sample
EXPERIMENTALAll 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)
Interventions
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).
Eligibility Criteria
You may qualify if:
- Males and females ages 14-17 years-old;
- English-speaking for assent and interview completion;
- Capacity to provide assent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2024
First Posted
April 17, 2024
Study Start
April 6, 2024
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share