Alcohol Use DisorderNCT04929288
Neural and Hormonal Influences on Sex Differences in Risk for AUD
A study testing Alcohol in people with Alcohol Use Disorder, run by Jessica Weafer at 1 site in United States.
Trial summary
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Read more about this study
- Who is it for?
- Ages 21 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2021to 30 Jun 2027
- Phase
- Interventional
- 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- consume 4/5 drinks per week
- fluent in English
- high school education
- right-handed
- regular menstrual cycles (women)
Who cannot join
- serious medical problems
- body weight <110 or >210 lbs
- current medical or psychiatric conditions requiring medication for which alcohol is contraindicated
- substance use disorder other than alcohol
- current or recent history of inpatient/intensive treatment for addictive behaviors
- pregnant, nursing, on hormonal contraception
- contraindications for fMRI
- smoking > 5 cigarettes per day
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, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jessica Weafer, 614-366-0163, jessica.weafer@osumc.edu
Jessica Weafer, PhD
About this study
Official title: Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown.
The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).
- Conditions
- Alcohol Use Disorder
- Being tested
- Alcohol
- Keywords
- sex, inhibitory control, risk factor, hormone, fMRI, menstrual cycle
- Medical subject headings
- Alcoholism, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Participants will complete three experimental sessions. In each session, participants will provide detailed reports of their alcohol consumption over the past five days, and they will provide a blood sample for hormone assays. They will perform tasks during fMRI to assess each of the neurofunctional addiction domains: inhibitory control, negative emotionality, and cue reactivity. Following the fMRI scan, subjects will self-administer intravenous alcohol to provide a controlled assessment of pharmacologically-driven alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Males | Experimental | Participants in this group will be adult male drinkers. Receives: Drug: Alcohol |
| Females | Experimental | Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase. Receives: Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural inhibitory function
One measure of neural inhibitory function during performance of the stop signal task will be activity (as measured by BOLD % signal change)
Measured: 13 minutes
Neural inhibitory function
The other measure of neural inhibitory function during performance of the stop signal task will be functional connectivity for the StopInh>Go contrast.
Measured: 13 minutes
Neural negative emotionality
One measure of neural negative emotionality during performance of the Emotional Pictures Task will be activity (as measured by BOLD % signal change)
Measured: 14 minutes
Neural negative emotionality
The other measure of neural negative emotionality during performance of the Emotional Pictures Task will be functional connectivity for the Negative>Neutral contrast.
Measured: 14 minutes
Neural alcohol cue reactivity
One measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be activity (as measured by BOLD % signal change)
Measured: 12 minutes
Neural alcohol cue reactivity
The other measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be functional connectivity for the Alcohol>Neutral contrast.
Measured: 12 minutes
Intravenous alcohol self-administration (IV-ASA)
One measure of IV-ASA will be peak BrAC (mg%; highest BrAC obtained during the IV-ASA period)
Measured: 60 minutes
Intravenous alcohol self-administration (IV-ASA)
Another measure of IV-ASA will be whether or not a participant reached binge level of alcohol exposure (80mg%)
Measured: 60 minutes
Intravenous alcohol self-administration (IV-ASA)
The final measure of IV-ASA will be time to reach binge level of alcohol exposure (80mg%)
Measured: 60 minutes
Self-reported current alcohol consumption
One measure of current alcohol consumption will be number of binge days (4/5 or more drinks in a sitting for women/men) as determined by responses on the Timeline Followback.
Measured: 20 minutes
Self-reported current alcohol consumption
The other measure of current alcohol consumption will be average peak BrAC obtained on drinking days over the past 5 days, as determined by responses on the Timeline Followback.
Measured: 20 minutes
Prospective alcohol consumption
One measure of prospective alcohol consumption will be number of binge episodes as determined by responses on the 90-day Timeline Followback.
Measured: 18 months
Prospective alcohol consumption
The other measure of prospective alcohol consumption will be drinking days per month, as determined by responses on the 90-day Timeline Followback.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start11 May 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica Weafer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Jessica Weafer, Ohio State University
- Investigators
- Jessica Weafer, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929288
- Sponsor's protocol ID
- 58758
- Other IDs
- R01AA028503
- Status last verified
- May 2026
- First submitted
- 11 Nov 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
- ClinicalTrials.gov ID
- NCT04929288
- Acronym / sponsor ID
- 58758
- Conditions
- Alcohol Use Disorder
- Keywords
- sex, inhibitory control, risk factor, hormone, fMRI, menstrual cycle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jessica WeaferUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jun 2021 (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 sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown.
The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | Experimental | Drug: AlcoholParticipants in this group will be adult male drinkers. |
| Females | Experimental | Drug: AlcoholParticipants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase. |
Who may qualify
- Ages
- 21 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- consume 4/5 drinks per week
- fluent in English
- high school education
- right-handed
- regular menstrual cycles (women)
Key exclusion criteria (8 listed)
- serious medical problems
- body weight <110 or >210 lbs
- current medical or psychiatric conditions requiring medication for which alcohol is contraindicated
- substance use disorder other than alcohol
- current or recent history of inpatient/intensive treatment for addictive behaviors
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 complete three experimental sessions. In each session, participants will provide detailed reports of their alcohol consumption over the past five days, and they will provide a blood sample for hormone assays. They will perform tasks during fMRI to assess each of the neurofunctional addiction domains: inhibitory control, negative emotionality, and cue reactivity. Following the fMRI scan, subjects will self-administer intravenous alcohol to provide a controlled assessment of pharmacologically-driven alcohol consumption. | Drug | Females, Males |
Primary outcome
Neural inhibitory function
Time frame: 13 minutes
One measure of neural inhibitory function during performance of the stop signal task will be activity (as measured by BOLD % signal change)
Neural inhibitory function
Time frame: 13 minutes
The other measure of neural inhibitory function during performance of the stop signal task will be functional connectivity for the StopInh>Go contrast.
Neural negative emotionality
Time frame: 14 minutes
One measure of neural negative emotionality during performance of the Emotional Pictures Task will be activity (as measured by BOLD % signal change)
Neural negative emotionality
Time frame: 14 minutes
The other measure of neural negative emotionality during performance of the Emotional Pictures Task will be functional connectivity for the Negative>Neutral contrast.
Neural alcohol cue reactivity
Time frame: 12 minutes
One measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be activity (as measured by BOLD % signal change)
Neural alcohol cue reactivity
Time frame: 12 minutes
The other measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be functional connectivity for the Alcohol>Neutral contrast.
Intravenous alcohol self-administration (IV-ASA)
Time frame: 60 minutes
One measure of IV-ASA will be peak BrAC (mg%; highest BrAC obtained during the IV-ASA period)
Intravenous alcohol self-administration (IV-ASA)
Time frame: 60 minutes
Another measure of IV-ASA will be whether or not a participant reached binge level of alcohol exposure (80mg%)
Intravenous alcohol self-administration (IV-ASA)
Time frame: 60 minutes
The final measure of IV-ASA will be time to reach binge level of alcohol exposure (80mg%)
Self-reported current alcohol consumption
Time frame: 20 minutes
One measure of current alcohol consumption will be number of binge days (4/5 or more drinks in a sitting for women/men) as determined by responses on the Timeline Followback.
Self-reported current alcohol consumption
Time frame: 20 minutes
The other measure of current alcohol consumption will be average peak BrAC obtained on drinking days over the past 5 days, as determined by responses on the Timeline Followback.
Prospective alcohol consumption
Time frame: 18 months
One measure of prospective alcohol consumption will be number of binge episodes as determined by responses on the 90-day Timeline Followback.
Prospective alcohol consumption
Time frame: 18 months
The other measure of prospective alcohol consumption will be drinking days per month, as determined by responses on the 90-day Timeline Followback.
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Jessica Weafer, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Alcohol Use Disorder, run by Jessica Weafer 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 May 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.
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 Jessica Weafer, PhD (614-366-0163, Jessica.Weafer@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural inhibitory function (time frame: 13 minutes). The study lists 13 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 22 May 2026.