- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118580
Neural Correlates During Alcohol Intoxication
Aggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Julian Roberts, R.N.
- Phone Number: 937-510-3951
- Email: julian.roberts@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
-
Contact:
- Emil Coccaro, M.D.
- Phone Number: 773-853-1338
- Email: emil.coccaro@osumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral alcohol drink
|
95% Ethanol diluted in Grape-flavored drink
|
Placebo Comparator: Placebo (non-alcohol drink)
|
Grape-flavored drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortico-limbic Response to Anger Faces
Time Frame: 60-120 minutes after Ethanol (or Placebo) drink
|
Orbito-frontal and Amygdala responses to Anger Faces
|
60-120 minutes after Ethanol (or Placebo) drink
|
Brain Connectivity
Time Frame: 60-120 minutes after Ethanol (or Placebo) drink
|
Resting State
|
60-120 minutes after Ethanol (or Placebo) drink
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emil Coccaro, M.D., The Ohio State University Wexner Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Disruptive, Impulse Control, and Conduct Disorders
- Alcoholic Intoxication
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Ethanol
Other Study ID Numbers
- 2020H0369
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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