An Early Phase 1 interventional study of Alcohol and Placebo in Sexual Assault and Alcohol Intoxication, sponsored by Ohio State University. Not yet recruiting at 1 site in United States. Open to female participants aged 21 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Ohio State University · Early Phase 1, Interventional, and Basic science
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:
Participants will:
92 studies on the registry are indexed under Alcoholic Intoxication; 15 are open to participants now.
This study's planned enrollment of 220 is above the median of 123 across 76 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria for All Participants:
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.
Exclusion Criteria for All Participants:
Additional Exclusion Criteria for HD+SA Group:
- Report a first onset SA within the past 30 days
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.
Drug: Alcohol · Drug: Placebo
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.
Drug: Alcohol · Drug: Placebo
Participants will receive 80 mg% intravenous alcohol.
Participants receive placebo (saline) intravenously.
Startle eyeblink potentiation during the threat task
Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Subjective affective response to alcohol in the lab
Participants will complete the Profile of Mood States (POMS) throughout the placebo and alcohol administration protocols. The Profile of Mood States Anxiety subscale consists of 9 items, with each item rated from 0 (not at all) to 4 (extremely), resulting in a total score ranging from 0 to 36. Higher scores indicate greater subjective anxiety, while lower scores indicate less subjective anxiety. The Anxiety subscale will serve as the primary measure of subjective anxiety and will be compared between the placebo and alcohol sessions.
Time frame: At the Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Subjective effects of alcohol in the lab
Participants will rate the degree to which they 'feel', 'like', and 'want more' of the infused substance on a visual analogue scale ranging from 0 ('not at all') to 100 ('extremely'). The 'like' and 'want more' scales will serve as the primary measures of drug liking and drug wanting, respectively.
Time frame: At the Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Ecological momentary assessment (EMA) of affective response to alcohol in the real world
Up to five times per day, participants will complete ecological momentary assessments (EMA) of their current anxiety, distress, and other mood states. Participants will rate each emotion on a 0-5 scale, where 0 = not at all and 5 = extremely. Affect will be assessed during periods of sobriety and intoxication.
Time frame: Assessed daily for 21-days
Transdermal alcohol concentration (TAC)
Participants' TAC will provide an objective estimate of alcohol consumption.
Time frame: Assessed daily for 21-days
Plan to share: Yes — De-identified data, including startle eyeblink and behavior, from this project will be submitted to the The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.
Time frame: The data will be submitted biannually.
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ethanol