Recruiting
Phase 2

Observational Study

Sponsor:

Ohio State University

Code:

NCT06118580

Conditions

Alcohol Use Disorder

Intermittent Explosive Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Alcohol (Ethanol)

Placebo

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder

Intermittent Explosive Disorder

Study ID

NCT06118580

Start date

Jun 8, 2023

Status verified date

Mar, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Oral alcohol drink

placebo comparator: Placebo (non-alcohol drink)

Interventions

Alcohol (Ethanol)

95% Ethanol diluted in Grape-flavored drink

Placebo

Grape-flavored drink

Primary outcome measure

  • Cortico-limbic Response to Anger Faces [ Time Frame: 60-120 minutes after Ethanol (or Placebo) drink ]
  • Brain Connectivity [ Time Frame: 60-120 minutes after Ethanol (or Placebo) drink ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

More Information

Sponsor

Ohio State University

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

  • AUD
  • IED
  • Social Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-03-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.