Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Task-based behavioral intervention; Behavioral: Task-based behavioral intervention

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shivani Doshi; Phone Number: 212-241-6582; Email: shivani.doshi@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Uraina Clark, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: no stress exposure; no threat stress	Behavioral: Task-based behavioral intervention; Brief behavioral intervention is absent of stressors.; Behavioral: Task-based behavioral intervention; Brief behavioral intervention involves interacting with common everyday types of stress.
Active Comparator: stress exposure; exposure to stress threat	Behavioral: Task-based behavioral intervention; Brief behavioral intervention is absent of stressors.; Behavioral: Task-based behavioral intervention; Brief behavioral intervention involves interacting with common everyday types of stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Uraina Clark, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Impulsive Behavior
• Other Study ID Numbers: GCO 19-0250; R01AA028023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No