Alcohol Use DisorderPhase 2NCT06118580
Neural Correlates During Alcohol Intoxication
A Phase 2 study testing Alcohol (Ethanol) in people with Alcohol Use Disorder and Intermittent Explosive Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Intermittent Explosive Disorder
- What is being tested?
- Alcohol (Ethanol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Emil Coccaro, M.D., 773-853-1338, emil.coccaro@osumc.edu
About this study
Official title: Aggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication.
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.
Read the 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 development and maintenance of impulsive aggressive behaviors. SEIP involves a multi-stage set of processes involving (1) encoding of social information, (2) attribution of the intent of the behavior of the other participant, and (3) emotional response. Ultimately, deficits in SEIP lead to aggressive behavior because the misperception of emotional stimuli in social encounters leads to hostile attribution, anger, and then, an inappropriate aggressive response. Experimental studies consistently demonstrate that acute intake of alcohol facilitates aggressive behavior. These studies have typically measured aggression with the Taylor Aggression Paradigm (TAP) in which aggression occurs in the context of electric shocks to a fictitious opponent in response to electric shocks that this opponent gives to the subject during a reaction-time task. Generally, individuals who receive alcohol respond more aggressively (i.e., set higher shocks) than those who receive a non-alcoholic placebo beverage. Importantly, these studies report that provocation is a necessary component for aggressive behavior to occur during alcohol intoxication. Simply put, alcohol-induced aggression is elicited when participants are provoked. Other relevant factors in alcohol-related aggression include impairments in executive cognitive function (ECF) and disruption of cognitive processes critical for self-regulation (e.g., attention, inhibition, information processing, and decision making), all of which are important in social-emotional information processing (SEIP). In fMRI studies, during alcohol infusion, decreased responses were observed in cortical areas [anterior cingulate cortex (ACC) and in the dorsomedial PFC (dmPFC)], and increased responses in subcortical areas [AMYG and ventral striatum (VS)]. In addition, increases in responses in AMYG and in VS were both correlated with aggressive responding to provocation during the TAP test. Emerging data indicate that acute alcohol intoxication alters cortico-limbic circuits in healthy, non-alcoholic, individuals and that history of alcoholism or aggression also alters these circuits.
- Being tested
- Alcohol (Ethanol), Placebo
- Keywords
- AUD, IED, Social Cognition
- Medical subject headings
- Alcoholism, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol (Ethanol)Drug
95% Ethanol diluted in Grape-flavored drink
PlaceboDrug
Grape-flavored drink
| Study group | Role | What they receive |
|---|---|---|
| Oral alcohol drink | Experimental | Not described Receives: Drug: Alcohol (Ethanol) |
| Placebo (non-alcohol drink) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortico-limbic Response to Anger Faces
Orbito-frontal and Amygdala responses to Anger Faces
Measured: 60-120 minutes after Ethanol (or Placebo) drink
Brain Connectivity
Resting State
Measured: 60-120 minutes after Ethanol (or Placebo) drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start8 Jun 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Emil Coccaro, Ohio State University
- Investigators
- Emil Coccaro, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118580
- Sponsor's protocol ID
- 2020H0369
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication.
- ClinicalTrials.gov ID
- NCT06118580
- Acronym / sponsor ID
- 2020H0369
- Keywords
- AUD, IED, Social Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 development and maintenance of impulsive aggressive behaviors. SEIP involves a multi-stage set of processes involving (1) encoding of social information, (2) attribution of the intent of the behavior of the other participant, and (3) emotional response. Ultimately, deficits in SEIP lead to aggressive behavior because the misperception of emotional stimuli in social encounters leads to hostile attribution, anger, and then, an inappropriate aggressive response. Experimental studies consistently demonstrate that acute intake of alcohol facilitates aggressive behavior. These studies have typically measured aggression with the Taylor Aggression Paradigm (TAP) in which aggression occurs in the context of electric shocks to a fictitious opponent in response to electric shocks that this opponent gives to the subject during a reaction-time task. Generally, individuals who receive alcohol respond more aggressively (i.e., set higher shocks) than those who receive a non-alcoholic placebo beverage. Importantly, these studies report that provocation is a necessary component for aggressive behavior to occur during alcohol intoxication. Simply put, alcohol-induced aggression is elicited when participants are provoked. Other relevant factors in alcohol-related aggression include impairments in executive cognitive function (ECF) and disruption of cognitive processes critical for self-regulation (e.g., attention, inhibition, information processing, and decision making), all of which are important in social-emotional information processing (SEIP). In fMRI studies, during alcohol infusion, decreased responses were observed in cortical areas [anterior cingulate cortex (ACC) and in the dorsomedial PFC (dmPFC)], and increased responses in subcortical areas [AMYG and ventral striatum (VS)]. In addition, increases in responses in AMYG and in VS were both correlated with aggressive responding to provocation during the TAP test. Emerging data indicate that acute alcohol intoxication alters cortico-limbic circuits in healthy, non-alcoholic, individuals and that history of alcoholism or aggression also alters these circuits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral alcohol drink | Experimental | Drug: Alcohol (Ethanol) |
| Placebo (non-alcohol drink) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria:
- Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
- Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria:
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol (Ethanol)95% Ethanol diluted in Grape-flavored drink | Drug | Oral alcohol drink |
| PlaceboGrape-flavored drink | Drug | Placebo (non-alcohol drink) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emil Coccaro, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alcohol (Ethanol) in people with Alcohol Use Disorder and Intermittent Explosive Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julian Roberts, R.N. (937-510-3951, julian.roberts@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortico-limbic Response to Anger Faces (time frame: 60-120 minutes after Ethanol (or Placebo) drink). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.