Neural Correlates During Alcohol Intoxication

Aggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication.

Neural Correlates During Alcohol Intoxication (NCT06118580) is a Phase 2 interventional studying Alcohol Use Disorder and Intermittent Explosive Disorder, sponsored by Ohio State University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Alcohol Use Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 144 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Alcohol Use Disorder subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria: 1. 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD. 3. PCL-SV psychopathy score \< 18 4. Able/willing to abstain from alcohol for 24 hours before MRI scanning. 5. Physically healthy (confirmed by comprehensive medical history and physical exam) and does not have metal implants, plates, or screws in body or head (MRI safety issue). 6. If a smoker, consumes no more than 15 cigarettes per day. 7. Able to give willing to sign a consent form. 2. Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria: 1. Life History of Aggression (LHA) score \> 12 2. In addition AGG participants must report: 1. Current history of at least two (2) angry outbursts a week (on average) for the past three months and/or three significant angry aggressive outbursts in which other people are assaulted and/or property is damaged in the past year. 2. Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated). 3. Angry outbursts are associated with distress and/or impairment; 4. Angry outbursts do not occur exclusively during another disorder or condition. 3. No lifetime history of AUD (from DSM-5 criteria). 3. Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria: 1. Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria: 1. 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD. 3. PCL-SV psychopathy score \< 18 4. Able/willing to abstain from alcohol for 24 hours before MRI scanning. 5. Physically healthy (confirmed by comprehensive medical history and physical exam) and does not have metal implants, plates, or screws in body or head (MRI safety issue). 6. If a smoker, consumes no more than 15 cigarettes per day. 7. Able to give informed consent. 2. Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria: 1. Life History of Aggression (LHA) score \> 12 2. In addition AGG participants must report: 1. Current history of at least two (2) angry outbursts a week (on average) for the past three months and/or three significant angry aggressive outbursts in which other people are assaulted and/or property is damaged in the past year. 2. Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated). 3. Angry outbursts are associated with distress and/or impairment; 4. Angry outbursts do not occur exclusively during another disorder or condition. 3. No lifetime history of AUD (from DSM-5 criteria). 3. Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria: 1. Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD. 4. Inclusion Criteria for AUD+ / AGG+ Participants: These participants meet criteria for both AUD and AGG as described above. 5. Inclusion Criteria for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria: 1. Does not meet DSM-5 criteria for current or past alcohol use disorder (AUD). 2. LHA score is less than 12. 3. Does not meet DSM-5 Criteria for a current, or past, major psychiatric disorder. b. Study Exclusion Criteria: 1\) \< 21 years of age or \> 55 years of age. 2) Meets criteria for other (Non-AUD) current DSM-5 Substance Use Disorder (excluding tobacco use disorder provided the participant consumes no more than 15 cigarettes per day). 3\) Life history of bipolar disorder, schizophrenia, organic mental syndrome or intellectual deficiency (i.e., IQ \< 70 by WRAT). 4\) Drug screen positive for amphetamines, barbituates, benzodiazepines, cocaine, phencyclidine, or opiates. 5\) Positive urine pregnancy test 6) Clinically significant medical condition (current and active medical condition requiring daily prescribed medication). 7\) PCL-SV psychopathy score \> 18 (see above). 8) Score \> 8 on the Clinical Institute Withdrawal Assessment-Revised (CIWA-Ar). 9\) Treatment with antipsychotic medications within two weeks of study entry. 10) Current suicidal ideation. 11) Metal in body, history of \> 5 min loss of consciousness, left-handedness or body weight \> 300lbs (fMRI exclusions). 12\) Unable/unwilling to abstain from alcohol for 24 hours and recreational drugs for 48 hours prior to session arrival. 13\) Unable to comply with study procedures. 14) Unable to sign informed consent document. 15) Taking of anticoagulants. 16) Drinks less than 2 drinks per week 17) Has not had a binge drinking episode (5+ for men, 4+ for women) in the past 3 months.

Treatments Being Tested

DRUG

Alcohol (Ethanol)

95% Ethanol diluted in Grape-flavored drink

DRUG

Placebo

Grape-flavored drink

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06118580), the sponsor (Ohio State University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06118580 clinical trial studying?

Who can participate in NCT06118580?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06118580?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06118580. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06118580. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.