Status:
RECRUITING
Neural Correlates During Alcohol Intoxication
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Intermittent Explosive Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
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...
Detailed Description
A critical issue related to aggression and to alcohol-related aggression is the role of social-emotional information processing (SEIP) including hostile attribution bias (HAB). SEIP can explain the de...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants: All candidates for this study must meet the following 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.
- Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
- 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).
- Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following 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.
- Inclusion Criteria for AUD+ / AGG+ Participants: These participants meet criteria for both AUD and AGG as described above.
- Inclusion Criteria for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria:
- 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
- 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.
Key Trial Info
Start Date :
June 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06118580
Start Date
June 8 2023
End Date
August 31 2026
Last Update
March 27 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210