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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05675332

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

280

Enrollment

Location

Arms

37.7

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Behavioral: Task-based behavioral intervention Behavioral: Task-based behavioral intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 9, 2022

Anticipated Primary Completion Date :

Jan 31, 2026

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: no stress exposure

no threat stress

Behavioral: Task-based behavioral intervention

Brief behavioral intervention is absent of stressors.

Active Comparator: stress exposure

exposure to stress threat

Behavioral: Task-based behavioral intervention

Brief behavioral intervention involves interacting with common everyday types of stress.

Outcome Measures

Primary Outcome Measures

Blood oxygen-level dependent (BOLD) signal [Baseline]
Blood oxygen-level dependent (BOLD) signal in brain regions of interest (ROI) measured using fMRI
Resting-state functional connectivity in brain regions [Baseline]
Resting-state functional connectivity - brain activity measured using fMRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Uraina Clark, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uraina S Clark, Associate Professor, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT05675332

Other Study ID Numbers:

GCO 19-0250
R01AA028023

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Dec 15, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Alcohol Drinking

Impulsive Behavior

Study Results

No Results Posted as of Jan 9, 2023