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NOT YET RECRUITING
NCT07810946
PHASE1/PHASE2

Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Alcohol withdrawal syndrome is a highly morbid condition affecting a substantial percentage of patients hospitalized who have alcohol use disorders, estimated at 5-6% of all hospitalized patients. Standard treatment paradigms for alcohol withdrawal syndrome have common and serious side effects, and do not fully address this condition's underlying pathophysiology. This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive treatment for alcohol withdrawal in hospitalized patients that will to set the stage for future investigations of its efficacy as an adjunctive treatment in the hospital setting.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-09-01

Completion Date

2029-06-30

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Sodium Acetate

Sodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (\~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first.

DRUG

Placebo

The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.

Locations (1)

University of Colorado, Anshcutz Medical Campus

Aurora, Colorado, United States