A Phase 2 interventional study of Alcohol (Ethanol) and Placebo in Alcohol Use Disorder and Intermittent Explosive Disorder, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Ohio State University · Phase 2, Interventional, and Basic science
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Among 19 studies testing ethanol in Alcoholism — 7 open to participants now, 9 under way, none of them phase 3. Ethanol · Alcoholism.
Among the 19 studies testing ethanol in Alcoholism, this one is the 10th largest by planned enrollment, is one of 2 that started in 2023, is one of 6 in phase 2, and was the 16th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →7 of the 19 studies testing ethanol in Alcoholism are open now, in 1 country. Recruiting first, the newest first:
University of Southern California · Sites in United States
Ages 21–28 · Healthy volunteers
Jessica Weafer · Sites in United States
Ages 21–25 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 21–65
Brown University · Sites in United States
Ages 21–50 · Healthy volunteers
Jessica Weafer · Sites in United States
Ages 21–26 · Healthy volunteers
By country, each count listing its studies:
Ethanol: first FDA approval 1946 (ALCOHOL 5% AND DEXTROSE 5%). What it is approved for, and how studies give it, is on its page →
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 21 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 144 is above the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 144 across the 19 interventional studies. Of the 9 that completed or were terminated, 5 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 19 has an industry lead sponsor. The 10 most frequent:
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Ohio State University has 6 studies filed under Alcoholism — fewer than ten, so there is no comparison to draw.
5 of the studies testing ethanol in Alcoholism that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03827460Indiana UniversitySex Differences in the Response to Abstinence From Alcohol. | 2027-02-28 |
| NCT06494891University of California, Los AngelesMotivation for IV Alcohol Self-Administration in Humans | 2027-04-30 |
| NCT04929288Jessica WeaferNeural and Hormonal Influences on Sex Differences in Risk for AUD | 2027-06-30 |
| NCT05389930Brown UniversityCannabis' Impact on Alcohol Consumption | 2027-08-31 |
| NCT05929677Jessica WeaferImpulsivity Domains and Subjective Response | 2027-09-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 19 studies testing ethanol in Alcoholism, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Alcohol intoxication is responsible for a large proportion of violent crime/assault and personal injury in our society. While a number of variables have been associated with alcohol-related aggression, high trait aggression and impaired executive function have been identified as key factors. Both Alcohol Use Disorder (AUD) and Impulsive Aggression behavior (AGG) are related to impaired social-emotional information processing (SEIP) whereby social threat cues, especially ones that are ambiguous in nature, lead to hostile attribution and negative emotional response to the "other" and, then, aggression against the "other". Thus, understanding the underlying neuroscience of SEIP under the influence of alcohol will be critical to identifying targets for intervention to reduce alcohol-related aggressive behavior. In addition to potential pharmacologic and cognitive-behavioral based interventions, such interventions may also involve the rehabilitation of aberrant neuronal circuits underlying social cognitive function through neuroplasticity-based remediation exercises. This study is designed to see how brain activation of cortico-limbic circuits involving social-emotional information processing, analyzed by fMRI Imaging, are impacted by alcohol administration in those with and without aggressive disorders and with and without alcohol use disorder.
A critical issue related to aggression and to alcohol-related aggression is the role of social-emotional information processing (SEIP) including hostile attribution bias (HAB). SEIP can explain the development and maintenance of impulsive aggressive behaviors. SEIP involves a multi-stage set of processes involving (1) encoding of social information, (2) attribution of the intent of the behavior of the other participant, and (3) emotional response. Ultimately, deficits in SEIP lead to aggressive behavior because the misperception of emotional stimuli in social encounters leads to hostile attribution, anger, and then, an inappropriate aggressive response. Experimental studies consistently demonstrate that acute intake of alcohol facilitates aggressive behavior. These studies have typically measured aggression with the Taylor Aggression Paradigm (TAP) in which aggression occurs in the context of electric shocks to a fictitious opponent in response to electric shocks that this opponent gives to the subject during a reaction-time task. Generally, individuals who receive alcohol respond more aggressively (i.e., set higher shocks) than those who receive a non-alcoholic placebo beverage. Importantly, these studies report that provocation is a necessary component for aggressive behavior to occur during alcohol intoxication. Simply put, alcohol-induced aggression is elicited when participants are provoked. Other relevant factors in alcohol-related aggression include impairments in executive cognitive function (ECF) and disruption of cognitive processes critical for self-regulation (e.g., attention, inhibition, information processing, and decision making), all of which are important in social-emotional information processing (SEIP). In fMRI studies, during alcohol infusion, decreased responses were observed in cortical areas [anterior cingulate cortex (ACC) and in the dorsomedial PFC (dmPFC)], and increased responses in subcortical areas [AMYG and ventral striatum (VS)]. In addition, increases in responses in AMYG and in VS were both correlated with aggressive responding to provocation during the TAP test. Emerging data indicate that acute alcohol intoxication alters cortico-limbic circuits in healthy, non-alcoholic, individuals and that history of alcoholism or aggression also alters these circuits.
Inclusion Criteria:
Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria:
Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
In addition AGG participants must report:
Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria:
Inclusion Criteria for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria:
b. Study 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Alcohol (Ethanol)
Drug: Placebo
95% Ethanol diluted in Grape-flavored drink
Grape-flavored drink
Cortico-limbic Response to Anger Faces
Orbito-frontal and Amygdala responses to Anger Faces
Time frame: 60-120 minutes after Ethanol (or Placebo) drink
Brain Connectivity
Resting State
Time frame: 60-120 minutes after Ethanol (or Placebo) drink
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Aug 2025, 26 months after the start.
Of 122 non-industry phase 2 interventional studies under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 26 months is below that.
Counting every sponsor, half of 134 studies reached it within 33 months; a quarter within 21 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ethanol