Phase
Condition
Alcohol Use Disorder
Treatment
Ketone Supplement
Control Diet
Ethanol
Clinical Study ID
Ages 21-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willingness to provide signed, informed consent and commit to completing studyprocedures.
Reported on at least one day in the month prior to consent of consuming 2 or morestandard alcohol drinks on a single day.
Exclusion
Exclusion Criteria:
Unwilling or unable to refrain from use, within 24 hours of the alcohol labprocedures, psychoactive medications or medication that may affect study results.
Current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)diagnosis of any major psychiatric disorder (other than nicotine use disorders, ormarijuana use disorders) as identified by clinical examination or structuredinterview that could interfere with study participation or make it hazardous for thesubject.
Currently taking medication(s) that could interfere with study participation or makeit hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics;lithium; psychotropic drugs not otherwise specified)
Positive urine drug screen, positive for all substances but marijuana at screeningor study visits (may be repeated once and if the result is negative on repeat, it isnot exclusionary).
A current, clinically significant physical disease or abnormality on the basis ofmedical history, or routine laboratory evaluation that can impact brain function,the use of a ketone supplement, administration of ketogenic diet, or the use ofalcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liverdisease, kidney disease, kidney stones, chronic metabolic acidosis or acardiomyopathy as determined by history and clinical exam).
Currently suffering from or has a history of stroke and/or stroke relatedspasticity.
Head trauma with loss of consciousness for more than 30 minutes or associated withskull fracture, inter-cranial bleeding or abnormal MRI (self-report, medicalhistory).
Weight greater than 225lbs (Need to cap amount of alcohol given based on weight toindividuals).
Females who are pregnant or breast-feeding
Contraindication to MRI, including presence of ferromagnetic objects, claustrophobiaor fear of enclosed, medical conditions that prevent subjects from lying comfortablyflat on his/ her back for up to 2 hrs.
Study Design
Study Description
Connect with a study center
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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