Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT06369623

Conditions

Adolescent Development

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

Interventions

Monetary Incentive Delay Task

Study Details

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.

Conditions

Adolescent Development

Study ID

NCT06369623

Start date

Apr 6, 2024

Status verified date

May, 2025

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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)

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).

Primary outcome measure

  • Amount of Brain Activation (BOLD Signal) during Monetary Incentive Delay Task by Condition [ Time Frame: Baseline, 18-month, 36-month. ]

Central Contacts and Locations

Central contacts

Greg Perlman, PhD

1-631-638-1922greg.perlman@stonybrookmedicine.edu

Lu-Ann Kozlowski, BSN

1-631-632-9036lu-ann.kozlowski@stonybrook.edu

Locations

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Greg Perlman, PhD

631-638-1922greg.perlman@stonybrookmedicine.edu

Principal Investigator:

Greg Perlman, PhD

More Information

Sponsor

Stony Brook University

Last update posted

May 15, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-05-15.