Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 1/2
- People taking part
- 75 people, planned
- Started
- 1 Nov 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sodium Acetate
- Placebo
- Record updated
- 30 October 2026
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting)
- Inpatient admission ordered
- Adult > 21 years old
Who cannot take part
- Receipt of >2L crystalloids prior to randomization
- End-stage renal disease or likely need for renal replacement therapy in the next 12 hours
- Advanced liver disease (Child's C or D)
- Uncontrolled mental health condition
- Heart failure with reduced ejection fraction (<30%)
- >24 hours since ED arrival
- Pregnant or incarcerated
- Unable to consent and/or no proxy
Where in United States
- University of Colorado, Anshcutz Medical CampusAurora, United StatesContact: Jeffrey McKeehan, AC-AGNPNot yet recruiting
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Intervention (IV acetate)Treatment being tested
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.
Treatment: Sodium Acetate
- Placebo (normal saline)Placebo, for comparison
The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 October 2026