An interventional study of Alcohol in Alcohol Use Disorder, sponsored by Jessica Weafer. Recruiting at 1 site in United States. Open to participants aged 21 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Jessica Weafer · Not applicable, Interventional, and Basic science
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).
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Jessica Weafer is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will be adult male drinkers.
Drug: Alcohol
Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.
Drug: Alcohol
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.
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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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%)
Time frame: 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%)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Jun 2027, 73 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 73 months is above that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ethanol