Monetary Incentive Delay Task for Probing Reward-related Neural Processes

NCT ID: NCT06369623

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-06
• Study Completion Date: 2028-11-30

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.

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:

1. The study involves humans

2. 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.

3. 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.

4. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Whole sample

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)

Group Type: EXPERIMENTAL

Monetary Incentive Delay Task

Intervention Type: OTHER

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).

Interventions

Monetary Incentive Delay Task

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females ages 14-17 years-old;
• English-speaking for assent and interview completion;
• Capacity to provide assent.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Greg Perlman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook Medicine

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Greg Perlman, PhD

Role: CONTACT

greg.perlman@stonybrookmedicine.edu

1-631-638-1922

Lu-Ann Kozlowski, BSN

Role: CONTACT

lu-ann.kozlowski@stonybrook.edu

1-631-632-9036

Facility Contacts

Greg Perlman, PhD

Role: primary

greg.perlman@stonybrookmedicine.edu

631-638-1922

Roman Kotov, PhD

Role: backup

Other Identifiers

IRB2023-00466

Identifier Type: -

Identifier Source: org_study_id