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

NCT07810946 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 26-11251R34AA033528-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Withdrawal; Alcohol Abstinence; Alcohol Use Disorder

Keywords

Alcohol Withdrawal

Outcome Measures

Primary Outcomes (4)

• Consent Rate for Study Participation per Week

  Number and percentage of patients meeting all study eligibility criteria who provide informed consent for study participation among all eligible patients identified during each week of recruitment.

  Assessed weekly during the study recruitment period, pre-consent

• Proportion of Randomized Participants Receiving Greater Than or Equal to 2 L of Assigned Study Infusion

  Number and percentage of randomized participants who receive at least 2 L of their assigned study infusion (study drug or placebo), as a measure of study protocol fidelity.

  After consent and randomization, immediately before study infusion, through completion or discontinuation of the study infusion, up to 72 hours.

• Proportion of Randomized Participants Withdrawn from Study for Safety Concerns

  Number and percentage of randomized participants for whom study participation or study intervention is discontinued because of a safety concern.

  After consent, immediately before study infusion, through completion, withdraw or discontinuation of the study infusion during the index hospitalization, up to 72 hours.

• Alcohol Withdrawal Medications Administered, per Patient

  Alcohol withdrawal medication utilization will be characterized descriptively for each participant by the total dose administered and total number of treatment days. Medications will be summarized by prespecified treatment category: (1) GABAergic medications, including benzodiazepines and phenobarbital, and (2) adjunctive medications, including dexmedetomidine and ketamine. Individual medications and medication classes will be reported separately, as applicable.

  After consent and randomization, through hospital discharge from the index hospitalization or study completion at 18 months, what occurs first.

Secondary Outcomes (12)

• Screening Volume

  Pre-consent. Assessed weekly during the study recruitment period

• Eligibility Rate

  Pre-consent. Assessed weekly during the study recruitment period

• Characteristics of Patients Who Do and Do Not Consent

  Pre-consent through completion of the consent/enrollment attempt during the index hospitalization

• Time to Informed Consent

  Pre-consent. From emergency department arrival through documentation of informed consent

• Study Drug Receipt, per Patient

  After consent and randomization. Assessed through completion or discontinuation of the study infusion, for up to 72 hours.

Study Arms (2)

Intervention (IV acetate)

EXPERIMENTAL

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: Sodium Acetate

Placebo (normal saline)

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Intervention (IV acetate)

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.

Also known as: normal saline

Placebo (normal saline)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting)
• Inpatient admission ordered
• Adult \> 21 years old

You may not qualify if:

• End-stage renal disease or likely need for renal replacement therapy in the next 12 hours
• Heart failure with reduced ejection fraction (\<30%)
• Receipt of \>2L crystalloids prior to randomization
• Advanced liver disease (Child's C or D)
• Uncontrolled mental health condition
• \>24 hours since ED arrival
• Pregnant or incarcerated
• Unable to consent and/or no proxy

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Colorado, Anshcutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Alcohol Abstinence; Alcoholism

Interventions

Sodium Acetate; Saline Solution

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ellen Burnham, MD

  University of Colorado, Department of Pulmonary, Allergy and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey McKeehan, AC-AGNP

CONTACT

303-724-6080; jeffrey.mckeehan@cuanschutz.edu

Ellen Burnham, MD

CONTACT

303-724-6078; ellen.burnham@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

US (1)