NCT05675332

Brief Summary

The purpose of this study is to investigate the behavioral and neural correlates of stress exposure. Results from this study will enrich the understanding of how sociocultural, behavioral, and neural factors combine to influence alcohol use.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

3.1 years

First QC Date

December 22, 2022

Last Update Submit

April 10, 2025

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • Blood oxygen-level dependent (BOLD) signal

    Blood oxygen-level dependent (BOLD) signal in brain regions of interest (ROI) measured using fMRI

    Baseline

  • Resting-state functional connectivity in brain regions

    Resting-state functional connectivity - brain activity measured using fMRI

    Baseline

Study Arms (2)

no stress exposure

PLACEBO COMPARATOR

no threat stress

Behavioral: Task-based behavioral intervention

stress exposure

ACTIVE COMPARATOR

exposure to stress threat

Behavioral: Task-based behavioral intervention

Interventions

Task-based behavioral interventionBEHAVIORAL

Brief behavioral intervention is absent of stressors.

no stress exposure

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 21 and 35 years of age (inclusive);
  • Fluent in English;
  • Right-handed

You may not qualify if:

  • Younger than 21 years of age;
  • Left-handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Uraina Clark, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Doshi

CONTACT

212-241-6582shivani.doshi@mssm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

December 9, 2022

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations

US(1)