NCT06118580 · Ohio State University
Neural Correlates During Alcohol Intoxication
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Alcohol (Ethanol)
95% Ethanol diluted in Grape-flavored drink
DRUG
Placebo
Grape-flavored drink
Primary outcome measures
Cortico-limbic Response to Anger Faces
Time frame: 60-120 minutes after Ethanol (or Placebo) drink
Orbito-frontal and Amygdala responses to Anger Faces
Brain Connectivity
Time frame: 60-120 minutes after Ethanol (or Placebo) drink
Resting State
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 21 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.
- Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
- Does not meet DSM-5 criteria for current or past alcohol use disorder (AUD).
- LHA score is less than 12.
- 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
- Columbus, Ohio
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2025 · Source of record for eligibility and locations