RECRUITING

Neural Correlates During Alcohol Intoxication

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Aggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication.

Quick Facts

Study Start:2023-06-08
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06118580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria:
  2. 1. 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
  3. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
  4. 3. PCL-SV psychopathy score \< 18
  5. 4. Able/willing to abstain from alcohol for 24 hours before MRI scanning.
  6. 5. 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).
  7. 6. If a smoker, consumes no more than 15 cigarettes per day.
  8. 7. Able to give informed consent.
  9. 2. Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
  10. 1. Life History of Aggression (LHA) score \> 12
  11. 2. In addition AGG participants must report:
  12. 1. 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.
  13. 2. Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated).
  14. 3. Angry outbursts are associated with distress and/or impairment;
  15. 4. Angry outbursts do not occur exclusively during another disorder or condition.
  16. 3. No lifetime history of AUD (from DSM-5 criteria).
  17. 3. Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria:
  18. 1. Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens.
  19. 2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
  20. 4. Inclusion Criteria for AUD+ / AGG+ Participants: These participants meet criteria for both AUD and AGG as described above.
  21. 5. Inclusion Criteria for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria:
  22. 1. Does not meet DSM-5 criteria for current or past alcohol use disorder (AUD).
  23. 2. LHA score is less than 12.
  24. 3. Does not meet DSM-5 Criteria for a current, or past, major psychiatric disorder.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Julian Roberts, R.N.
CONTACT
937-510-3951
julian.roberts@osumc.edu

Principal Investigator

Emil Coccaro, M.D.
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Emil Coccaro, M.D., PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • AUD
  • IED
  • Social Cognition

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Intermittent Explosive Disorder