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NCT04360018 · ClinicalTrials.gov registry record · Phase 1
Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
A Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04360018: Completed Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT04360018 is a Phase 1 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04360018, a Phase 1 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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 better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS. Objective: To study how alcohol impacts decisions about engaging in risky sex. Eligibility: Healthy adults ages 21-65 without alcohol use disorder Design: Participants will have 2 study visits, 1 month apart. They will arrive and depart via taxi. They will consume alcohol at 1 visit, chosen at random. At visit 1, participants will answer questions about HIV knowledge, HIV risk behaviors, and sexual interests. They will view pictures of clothed people and pick those they might have sex with. They will think about the person s risk of having an STD and whether they would use a condom during sex. At both visits, participants will sit in a bar-like room and have 2 drinks that may contain alcohol. Then they will have magnetic resonance imaging (MRI) brain scans. For this, they will lie on a table that slides in and out of a metal tube. The scanner makes loud noises; they will get earplugs. They will complete tasks that include looking at pictures and making choices about money. At the beginning of both visits the participants will be screened with urine drug test and pregnancy test. Duiring each visit the participants breath alcohol will be measured, and they will discuss whether they feel intoxicated. Participants will get snacks and stay at the clinic for up to 6 hours after the MRIs. ...
Primary Outcome
Participants will see a picture of one of the individuals selected during the pre-scan PSD procedure. They will also see two choices corresponding to 1) "Sex with this person without a condom NOW" or 2) "Sex with this person with a condom \[NOW or delay\] . Participants will have 6 seconds to press a button corresponding to their choice. Conditions of interest will vary as follows: choice difficulty- easy (probability of choosing later option \<0.33 or \>0.67) or hard (probability of choosing al
Interventions
- OTHER Alcohol beverage
- OTHER Placebo beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2025-04-02 |
| Phase | Phase 1 |
What the finished NCT04360018 record still lists
NCT04360018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Alcohol beverage is the first listed.
NCT04360018 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04360018 about?
NCT04360018 is a clinical study titled "Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors". 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 better understand how alcohol s effects on risky sexual behavior that might lead people to contract...
What is the current status of trial NCT04360018?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-03-18. Estimated completion is 2025-04-02.
What interventions are being tested in trial NCT04360018?
The interventions under investigation include: Alcohol beverage (OTHER), Placebo beverage (OTHER).
Who is sponsoring clinical trial NCT04360018?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04360018's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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