Neural Correlates During Alcohol Intoxication

NCT06118580 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020H0369
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

AUD; IED; Social Cognition

Outcome Measures

Primary Outcomes (2)

• Cortico-limbic Response to Anger Faces

  Orbito-frontal and Amygdala responses to Anger Faces

  60-120 minutes after Ethanol (or Placebo) drink

• Brain Connectivity

  Resting State

  60-120 minutes after Ethanol (or Placebo) drink

Study Arms (2)

Oral alcohol drink

EXPERIMENTAL

Drug: Alcohol (Ethanol)

Placebo (non-alcohol drink)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Alcohol (Ethanol) DRUG

95% Ethanol diluted in Grape-flavored drink

Oral alcohol drink

Placebo DRUG

Grape-flavored drink

Placebo (non-alcohol drink)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
• Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
• PCL-SV psychopathy score \< 18
• Able/willing to abstain from alcohol for 24 hours before MRI scanning.
• 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).
• If a smoker, consumes no more than 15 cigarettes per day.
• Able to give informed consent.
• Life History of Aggression (LHA) score \> 12
• In addition AGG participants must report:
• 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.
• Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated).
• Angry outbursts are associated with distress and/or impairment;
• Angry outbursts do not occur exclusively during another disorder or condition.
• No lifetime history of AUD (from DSM-5 criteria).
• Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens.

You may not qualify if:

• \) \< 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).
• \) Life history of bipolar disorder, schizophrenia, organic mental syndrome or intellectual deficiency (i.e., IQ \< 70 by WRAT).
• \) Drug screen positive for amphetamines, barbituates, benzodiazepines, cocaine, phencyclidine, or opiates.
• \) Positive urine pregnancy test 6) Clinically significant medical condition (current and active medical condition requiring daily prescribed medication).
• \) PCL-SV psychopathy score \> 18 (see above). 8) Score \> 8 on the Clinical Institute Withdrawal Assessment-Revised (CIWA-Ar).
• \) Unable/unwilling to abstain from alcohol for 24 hours and recreational drugs for 48 hours prior to session arrival.
• \) 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.

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Emil Coccaro, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Roberts, R.N.

CONTACT

937-510-3951; julian.roberts@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Placebo drink (without alcohol)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: June 8, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)