Neural Correlates During Alcohol Intoxication
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT06118580
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Alcohol Use Disorder
- Intermittent Explosive Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Alcohol (Ethanol) — DRUG95% Ethanol diluted in Grape-flavored drink
- Placebo — DRUGGrape-flavored drink
Study Details
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.
Key Dates
- Start date
- Jun 8, 2023
- Status verified
- Mar 2025
- Primary completion
- Aug 31, 2025
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 144 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Oral alcohol drink
- Placebo Comparator: Placebo (non-alcohol drink)
Primary Outcome Measure
Cortico-limbic Response to Anger Faces [ Time Frame: 60-120 minutes after Ethanol (or Placebo) drink ]
Central Contacts
- Julian Roberts, R.N.937-510-3951
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 |
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