💬In plain words
What the trial is, and whether it could suit you
This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age 21-65 years old
2. Able to provide written informed consent
3. Meets current DSM-5 criteria for mild to moderate (established using MINI)
4. Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)
5. Not seeking treatment for AUD (self-report)
Exclusion Criteria:
1. Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).
2. Use of psychoactive medications or medications that may affect study results (self-report, medical history).
3. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year.
4. Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).
5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).
6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
7. Clinically significant laboratory findings that could affect brain function (e.g., HIV+).
8. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
9. Pregnant or breast-feeding
10. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
11. BMI greater than 35.
12. Self-reported claustrophobia.
13. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).
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