Alcohol for Women With History of Sexual Assault

SG
Overseen ByStephanie Gorka
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine whether women who engage in heavy drinking with a history of sexual assault (SA) victimization show heightened baseline reactivity to uncertain threat (U-threat), whether alcohol reduces this reactivity and related anxiety, and how these processes link to real-world drinking behavior. The main questions it aims to answer are:

* Test whether heavy drinking women with a history of SA display exaggerated baseline reactivity to U-threat.

* In the lab, test whether alcohol intoxication is associated with decreases in reactivity to U-threat and subjective anxiety, particularly in heavy drinking women with a history of SA.

* In the real-world, test associations between SA victimization, reactivity to U-threat, alcohol consumption, and anxiolytic relief.

Participants will:

* Complete a screening and orientation session

* Complete two experimental lab sessions that will include intravenous (IV) administration of either 80mg% alcohol or placebo (saline), order counterbalanced

* Complete daily ecological momentary assessments (EMA) surveys for 21 days

* Wear a transdermal alcohol wrist biosensor (BACTrack Skyn) for 21-days

Are You a Good Fit for This Trial?

This trial is for college women who are heavy drinkers and have a history of sexual assault. Participants must be willing to attend lab sessions, wear an alcohol sensor wristband, and complete daily surveys for three weeks.

Inclusion Criteria

At least a high school education
Fluency in English
HD-SA Group: No exposure to lifetime DSM-5 Criterion A traumatic stressor; participants not excluded for accidents, injuries, or witnessing community violence
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Exclusion Criteria

Lifetime history of psychosis
HD+SA Group: Report a first onset sexual assault within the past 30 days
Body weight less than 110 lbs or greater than 210 lbs
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What Are the Treatments Tested in This Trial?

Trial Overview

The study compares how alcohol versus placebo affects anxiety and stress responses in women with past sexual assault while measuring real-world drinking patterns using wearable sensors and daily surveys. Each participant receives both alcohol and placebo in separate lab visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Heavy Drinking without a History of Sexual Assault Victimization (HD-SA)Experimental Treatment2 Interventions
Group II: Heavy Drinking with a History of Sexual Assault Victimization (HD+SA)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+