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

Part of paid clinical trials in Aurora, Colorado.

Sponsor: University of Colorado, Denver
Study ID: NCT07810946
Phase: PHASE1/PHASE2
Status: Not Yet Recruiting

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Conditions

Alcohol Abstinence
Alcohol Use Disorder
Alcohol Withdrawal

Eligibility Criteria

Sex: ALL
Age: 21 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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 Dates

First listed: Sep 9, 2026
Start date: Sep 1, 2026
Status verified: Sep 2026
Primary completion: Jun 30, 2029
Completion: Jun 30, 2029

Study Design

Enrollment: 75 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Intervention (IV 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.
Placebo Comparator: Placebo (normal saline)
The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.