Back to resultsEffects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Primary Purpose
Alcohol Drinking
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Task-based behavioral intervention
Task-based behavioral intervention
Sponsored by
About this trial
This is an interventional other trial for Alcohol Drinking
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
no stress exposure
stress exposure
Arm Description
no threat stress
exposure to stress threat
Outcomes
Primary Outcome Measures
Blood oxygen-level dependent (BOLD) signal
Blood oxygen-level dependent (BOLD) signal in brain regions of interest (ROI) measured using fMRI
Resting-state functional connectivity in brain regions
Resting-state functional connectivity - brain activity measured using fMRI
Secondary Outcome Measures
Full Information
NCT ID
NCT05675332
First Posted
December 22, 2022
Last Updated
December 22, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05675332
Brief Title
Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Official Title
Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 15, 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no stress exposure
Arm Type
Placebo Comparator
Arm Description
no threat stress
Arm Title
stress exposure
Arm Type
Active Comparator
Arm Description
exposure to stress threat
Intervention Type
Behavioral
Intervention Name(s)
Task-based behavioral intervention
Intervention Description
Brief behavioral intervention is absent of stressors.
Intervention Type
Behavioral
Intervention Name(s)
Task-based behavioral intervention
Intervention Description
Brief behavioral intervention involves interacting with common everyday types of stress.
Primary Outcome Measure Information:
Title
Blood oxygen-level dependent (BOLD) signal
Description
Blood oxygen-level dependent (BOLD) signal in brain regions of interest (ROI) measured using fMRI
Time Frame
Baseline
Title
Resting-state functional connectivity in brain regions
Description
Resting-state functional connectivity - brain activity measured using fMRI
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uraina Clark, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD
Learn more about this trial
Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
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