NCT06369623

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress45%
Apr 2024Nov 2028

Study Start

First participant enrolled

April 6, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.7 years

First QC Date

April 13, 2024

Last Update Submit

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

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)

Other: Monetary Incentive Delay Task

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).

Whole sample

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

RECRUITING

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

Locations