Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Early phase 1
- People taking part
- 220 people, planned
- Starts
- Dec 2026
- Expected to end
- Aug 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- Alcohol
- Placebo
- Record updated
- 26 October 2026
Who can take part
- Age
- 21 years to 29 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who cannot take part
- Positive urine screen for drugs other than cannabis
- Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)
- Current medical or psychiatric condition requiring medication for which alcohol consumption is contraindicated
- Substance use disorder other than mild and moderate alcohol use disorder
- Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
- Lifetime history of psychosis; Additional Exclusion Criteria for HD+SA Group:
- Body weight < 110 or > 210 lbs
- Pregnancy, nursing, or planning to become pregnant in the next 3 months
- Report smoking more than 5 cigarettes (or electronic equivalent) per day
- Report a first onset SA within the past 30 days
Other criteria
- General Inclusion Criteria for All Participants:
- Biological female
- 21-29 years old
- At least a high school education
- Fluency in English
- Heavy drinker as defined as 8 or more alcoholic drinks per week and at least two binge episodes (4 or more drinks for in a 2-hour period) in the past month; Additional Inclusion Criteria for Heavy Drinkers with History of Sexual Assault (HD+SA) Group:
- Self-reported experience of sexual assault victimization after age 14; Additional Inclusion Criteria for Heavy Drinkers without History of Sexual Assault (HD-SA) Group:
- No exposure to lifetime DSM-5 Criterion A traumatic stressor. Participants will not be excluded for accidents, injuries, or witnessing community violence to ensure the sample is representative
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 29 years old?
Where in United States
- Ohio State UniversityColumbus, United StatesContact: Stephanie GorkaNot yet recruiting
About the trial
What the trial wants to find out
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:
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* 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
The 2 groups in the trial
- Heavy Drinking with a History of Sexual Assault Victimization (HD+SA)Other group
Participants in this group will be required to be biological females between the ages of 21-29 who engage in heavy drinking with a history of sexual assault victimization after age 14.
Treatment: Alcohol and Placebo
- Heavy Drinking without a History of Sexual Assault Victimization (HD-SA)Other group
Participants in this group will be required to be biological females between the ages of 21-29 who engage in heavy drinking either without a history of sexual assault victimization after age 14.
Treatment: Alcohol and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07894289, who can take part
- Record updated
- 26 October 2026