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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first task

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eighth task

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protected Sex Discounting MRI-Scan Portion

Secondary outcome measures

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

0 / 1Eligibility criteria met

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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

802 Previous Clinical Trials

1,365,410 Total Patients Enrolled

424 Trials studying Alcoholism

985,833 Patients Enrolled for Alcoholism

Reza Momenan, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

9 Previous Clinical Trials

5,172 Total Patients Enrolled

8 Trials studying Alcoholism

5,138 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree might participants in arm one encounter harm?

"Arm one has been judged to have a safety rating of 1 due to it being an early-phase study, where there is only sparse data confirming its efficacy and security."

Answered by AI

Does the study permit senior citizens to participate?

"It is mandated that patients participating in this clinical trial are between 21 to 65 years of age. For those younger than 18 and older than 65, there exist alternative studies with a total sample size of 223 participants."

Answered by AI

Are there still vacancies available for this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was first announced on March 18th 2021, is still actively recruiting patients. The project aims to enrol 35 participants from 1 medical centre."

Answered by AI

How many participants have enrolled in this experiment?

"Yes, clinicaltrials.gov confirms that this trial is currently in the recruitment phase. This medical research project was initially posted on March 18th 2021 and further updated as recently as October 8th 2022. It seeks to enrol 35 patients from a single site."

Answered by AI

Do I meet the criteria to partake in this experiment?

"This medical experiment is in search of 35 patients who suffer from alcohol abuse and meet the following criteria: aged 21 to 65, consuming between 1 and 7 standard drinks/week if female; between 1 and 14 standard drinks/week if male (as per latest measurement within past 90 days), having at least one episode of binge drinking each month (4+ drinks for women, 5+ for men based on most recent record)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors

2021. "Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04360018.

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