Alcohol Use DisorderIntermittent Explosive Disorder
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 55
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
144 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for
This trial is looking for adults aged 21 to 55 to study how alcohol affects brain activity and aggression. Participants will complete a 24-hour period without alcohol before undergoing brain scans.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 21 to 55 years old
I consume more than 10 drinks per week or binge drink monthly
I am physically healthy and can provide informed consent
I have a low psychopathy score
I can abstain from alcohol for 24 hours before the study
You may not be able to join if
I am under 21 or over 55 years old
I have a current substance use disorder (not tobacco)
I have a history of bipolar disorder or schizophrenia
I have tested positive for certain drugs
I am currently pregnant
I have a significant medical condition requiring daily medication
I struggle with suicidal thoughts
I weigh over 300 pounds
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-emot…
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.
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Eligibility Criteria
Inclusion Criteria:
1. Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria:
1. 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
2. Consumes \> 10 drinks/week or reports binge drinking at lea…
Inclusion Criteria:
1. Inclusion Criteria for All Participants: All candidates for this study must meet the following criteria:
1. 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
2. Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
3. PCL-SV psychopathy score \< 18
4. Able/willing to abstain from alcohol for 24 hours before MRI scanning.
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).
6. If a smoker, consumes no more than 15 cigarettes per day.
7. Able to give informed consent.
2. Inclusion Criteria for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
1. Life History of Aggression (LHA) score \> 12
2. In addition AGG participants must report:
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.
2. Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated).
3. Angry outbursts are associated with distress and/or impairment;
4. Angry outbursts do not occur exclusively during another disorder or condition.
3. No lifetime history of AUD (from DSM-5 criteria).
3. Inclusion Criteria for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria:
1. Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens.
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. Inclusion Criteria for AUD+ / AGG+ Participants: These participants meet criteria for both AUD and AGG as described above.
5. Inclusion Criteria for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria:
1. Does not meet DSM-5 criteria for current or past alcohol use disorder (AUD).
2. LHA score is less than 12.
3. 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.
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