Sexual AssaultEarly Phase 1NCT07894289
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
A Early Phase 1 study testing Alcohol in people with Sexual Assault and Alcohol Intoxication, run by Ohio State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 29 years, women only
- Conditions the study is for
- Sexual Assault, Alcohol Intoxication
- What is being tested?
- Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Aug 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)
- Body weight < 110 or > 210 lbs
- Current medical or psychiatric condition requiring medication for which alcohol consumption is contraindicated
- Substance use disorder other than mild and moderate alcohol use disorder
- Positive urine screen for drugs other than cannabis
- Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
Show all 11Show fewer
- Pregnancy, nursing, or planning to become pregnant in the next 3 months
- Report smoking more than 5 cigarettes (or electronic equivalent) per day
- Lifetime history of psychosis.
- Additional Exclusion Criteria for HD+SA Group:
- Report a first onset SA within the past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ohio State University
Columbus, Ohio, 43210
Stephanie Gorka, 614-366-1027, stephanie.gorka@osumc.edu
About this study
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.
Read more
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
- Conditions
- Sexual Assault, Alcohol Intoxication
- Being tested
- Alcohol, Placebo
- Keywords
- sexual assault, Intravenous alcohol administration
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Participants will receive 80 mg% intravenous alcohol.
PlaceboDrug
Participants receive placebo (saline) intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Heavy Drinking with a History of Sexual Assault Victimization (HD+SA) | Other | 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. Receives: Drug: Alcohol; Drug: Placebo |
| Heavy Drinking without a History of Sexual Assault Victimization (HD-SA) | Other | 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. Receives: Drug: Alcohol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed daily for 21-days
Transdermal alcohol concentration (TAC)
Participants' TAC will provide an objective estimate of alcohol consumption.
Measured: Assessed daily for 21-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Stephanie M Gorka, PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894289
- Sponsor's protocol ID
- 2024H0264
- Other IDs
- 1R01AA032115-01A1
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
- ClinicalTrials.gov ID
- NCT07894289
- Acronym / sponsor ID
- 2024H0264
- Conditions
- Sexual Assault, Alcohol Intoxication
- Keywords
- sexual assault, Intravenous alcohol administration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy Drinking with a History of Sexual Assault Victimization (HD+SA) | Other | Drug: Alcohol, Drug: PlaceboParticipants 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. |
| Heavy Drinking without a History of Sexual Assault Victimization (HD-SA) | Other | Drug: Alcohol, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)
- Body weight < 110 or > 210 lbs
- Current medical or psychiatric condition requiring medication for which alcohol consumption is contraindicated
- Substance use disorder other than mild and moderate alcohol use disorder
- Positive urine screen for drugs other than cannabis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholParticipants will receive 80 mg% intravenous alcohol. | Drug | Heavy Drinking with a History of Sexual Assault Victimization (HD+SA), Heavy Drinking without a History of Sexual Assault Victimization (HD-SA) |
| PlaceboParticipants receive placebo (saline) intravenously. | Drug | Heavy Drinking with a History of Sexual Assault Victimization (HD+SA), Heavy Drinking without a History of Sexual Assault Victimization (HD-SA) |
Primary outcome
Startle eyeblink potentiation during the threat task
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
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.
Subjective affective response to alcohol in the lab
Time frame: At the Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
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.
Subjective effects of alcohol in the lab
Time frame: At the Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
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.
Ecological momentary assessment (EMA) of affective response to alcohol in the real world
Time frame: Assessed daily for 21-days
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.
Transdermal alcohol concentration (TAC)
Time frame: Assessed daily for 21-days
Participants' TAC will provide an objective estimate of alcohol consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol in people with Sexual Assault and Alcohol Intoxication, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gorka (614-366-1027, stephanie.gorka@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Startle eyeblink potentiation during the threat task (time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.