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Alcohol Impact on Decision-Making During HIV Risk Situations

Phase 1
Recruiting
Led By Reza Momenan, Ph.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
21 to 65 years old
Be older than 18 years old
Must not have
Significant history of head trauma or cranial surgery
Female participants only (or other individuals able to get pregnant): Currently pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first task

Summary

This trial is studying how alcohol impacts decisions about engaging in risky sex. Healthy adults ages 21-65 without alcohol use disorder are eligible. Participants will have 2 study visits, 1 month apart. They will consume alcohol at 1 visit, chosen at random.

Who is the study for?
This trial is for healthy adults aged 21-65 who drink alcohol in moderation (1-7 drinks/week for women, 1-14 for men) and have at least one binge drinking episode per month. It's not open to those seeking alcohol use disorder treatment, with significant head trauma or neurological diseases, abnormal liver tests, HIV positive individuals, pregnant or breastfeeding women, or anyone unable to understand English.
What is being tested?
The study examines the effect of alcohol on brain activity related to decisions about risky sexual behavior. Participants will consume alcoholic or placebo beverages and undergo MRI scans while performing tasks. They'll attend two sessions a month apart and discuss their feelings of intoxication.
What are the potential side effects?
Potential side effects from participating may include the usual risks associated with acute alcohol consumption such as impaired judgment and coordination. The MRI procedure might cause discomfort due to loud noises despite earplugs being provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had major head injuries or brain surgery.
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I am currently pregnant or breastfeeding.
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I have a neurological condition that could affect brain imaging studies.
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I am currently on PrEP medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eighth task
This trial's timeline: 3 weeks for screening, Varies for treatment, and eighth task for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Protected Sex Discounting MRI-Scan Portion
Secondary study objectives
Balanced Inventory of Desirable Responding
HIV Risk-Taking Behavior Scale
HIV and Sexual Behaviors Interview
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: arm oneActive Control1 Intervention
participants receive alcohol beverage
Group II: arm twoPlacebo Group1 Intervention
Placebo

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
839 Previous Clinical Trials
1,083,736 Total Patients Enrolled
459 Trials studying Alcoholism
823,796 Patients Enrolled for Alcoholism
Reza Momenan, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
9 Previous Clinical Trials
5,150 Total Patients Enrolled
8 Trials studying Alcoholism
5,116 Patients Enrolled for Alcoholism

Media Library

Alcohol beverage Clinical Trial Eligibility Overview. Trial Name: NCT04360018 — Phase 1
Alcoholism Research Study Groups: arm one, arm two
Alcoholism Clinical Trial 2023: Alcohol beverage Highlights & Side Effects. Trial Name: NCT04360018 — Phase 1
Alcohol beverage 2023 Treatment Timeline for Medical Study. Trial Name: NCT04360018 — Phase 1
~4 spots leftby Jun 2025
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