HA35 Acute Alcohol Study

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Healthy Controls

In brief

Eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.

Key facts

Study ID

NCT05025865

Run by

The Cleveland Clinic

People needed

24

Starts

2022-02-01

Expected to finish

2027-10-01

Last updated by the study team

2025-11-17

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
• Ability to understand and willingness to provide written consent

You may not qualify if…

• Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)
• Poorly controlled diabetes (Hemoglobin A1c >9.5 g/dl)
• Untreated hyper/hypothyroidism
• Uncontrolled hypertension or hypercholesterolemia
• End-stage renal disease
• Liver disease of any etiology
• Coronary artery disease or stroke
• Active intravenous drug use
• History of gastric bypass
• Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
• Pregnancy
• Past alcohol use disorder
• Abnormal clotting factors

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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