Understanding brain activity during alcohol intoxication and aggression

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

This study tests how drinking alcohol affects brain activity related to social cues and aggression in people.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 21 Years to 55 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06118580 on ClinicalTrials.gov

What this trial studies

This study investigates the neural mechanisms underlying social-emotional information processing during alcohol intoxication, particularly focusing on how it relates to aggressive behavior. Participants will consume either alcohol or a placebo while their brain activity is monitored using MRI scans. The research aims to identify how alcohol affects the perception of social cues and contributes to impulsive aggression. By examining these processes, the study seeks to uncover potential targets for interventions that could reduce alcohol-related aggression.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 21 to 55 who consume more than 10 drinks per week and have a history of impulsive aggression.

Not a fit: Patients who are currently abstaining from alcohol or seeking treatment for alcohol use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new interventions that help reduce aggressive behavior in individuals with alcohol use disorder.

How similar studies have performed: Other studies have shown that alcohol can facilitate aggressive behavior, but this specific investigation into the neural correlates of social-emotional processing during intoxication is relatively novel.

Eligibility criteria

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.

Where this trial is running

Columbus, Ohio

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Emil Coccaro, M.D. — Ohio State University
• Study coordinator: Julian Roberts, R.N.

Conditions Alcohol Use Disorder; Intermittent Explosive Disorder; AUD; IED; Social Cognition