Status:
COMPLETED
Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
Background: People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to...
Detailed Description
Study Description: Participants will complete baseline measures of sexual history and preferences, HIV risk and knowledge, and tasks designed to measure delay discounting of protected sex. At the fir...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 21 to 65 years old.
- EXCLUSION CRITERIA for Alcohol Administration/MR scanning:
- Having less than one binge drinking episode (episodes operationally defined as having consumed four or more drinks on one day if female/ five or more if male) based on the most recent measurement within the past 90 days of screening as determined by Alcohol Timeline Follow-back.
- Currently seeking treatment for alcohol use disorder
- Significant history of head trauma or cranial surgery
- History of neurological disease based on self-report or neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.
- Have fulfilled DSM-5 criteria for a current substance use disorder other than alcohol use disorder
- History of primary psychotic disorder
- Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dl;
- HIV positive
- Currently taking PrEP
- Female participants only (or other individuals able to get pregnant): Currently pregnant or breastfeeding
- Any flag on the MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
- Reported to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire
- Unable to understand and communicate in English at a level sufficient to complete questionnaires and tasks that are not validated in any language other than English.
Exclusion
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04360018
Start Date
March 18 2021
End Date
April 2 2025
Last Update
April 11 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892