Intravenous Acetate for Alcohol Withdrawal Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and feasibility of using an intravenous acetate solution (Sodium Acetate) as a new treatment for alcohol withdrawal syndrome in hospitalized patients. Managing alcohol withdrawal can be challenging with current treatments, which often have serious side effects. The study will compare the effects of the acetate solution to a placebo (a harmless inactive treatment) to determine if it can safely assist patients. Individuals currently receiving treatment for alcohol withdrawal in a hospital setting might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Is there any evidence suggesting that intravenous acetate is likely to be safe for humans?
Research has shown that intravenous acetate is safe and well-tolerated in people. In studies involving individuals with alcohol use disorders, the treatment proved practical and did not cause major side effects. It positively impacted brain activity without causing serious problems. Although still in the early stages of testing, these results suggest that sodium acetate can be safely administered to patients.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for alcohol withdrawal syndrome, which typically involve benzodiazepines, sodium acetate is a novel option that works by providing an alternative energy source for the brain during withdrawal. Researchers are excited about this treatment because it could potentially stabilize the body's metabolic processes more effectively without the sedative effects associated with traditional medications. Additionally, the intravenous delivery of sodium acetate allows for rapid administration and precise control over dosing, which could lead to quicker relief from withdrawal symptoms. This approach might offer a safer and faster alternative to existing therapies, particularly for patients with severe withdrawal symptoms.
What evidence suggests that intravenous acetate could be an effective treatment for alcohol withdrawal syndrome?
This trial will compare the effects of intravenous acetate with a placebo for treating alcohol withdrawal symptoms. Research has shown that intravenous acetate could help alleviate these symptoms. Acetate, a natural substance produced when the body breaks down alcohol, can also serve as an energy source for the brain. When alcohol consumption stops suddenly, brain acetate levels drop, potentially causing stress and cravings. Early studies found that intravenous acetate is safe and can enhance brain function. This suggests it might reduce withdrawal symptoms by balancing brain chemistry.678910
Who Is on the Research Team?
Ellen Burnham, MD
Principal Investigator
University of Colorado, Department of Pulmonary, Allergy and Critical Care Medicine
Are You a Good Fit for This Trial?
This trial is for hospitalized adults experiencing alcohol withdrawal. Participants must have a history of problem drinking or alcoholism and be currently going through withdrawal symptoms. People with certain medical conditions or who are unable to safely receive IV treatments may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous acetate or placebo as an adjunctive treatment for alcohol withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sodium Acetate
Trial Overview
The study tests if giving intravenous sodium acetate, alongside usual care, is safe and practical for treating alcohol withdrawal in the hospital. Some patients will get sodium acetate while others get a placebo (inactive treatment), assigned randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Citations
Intravenous Acetate as an Adjunctive Treatment for Alcohol ...
This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive ...
Sodium oxybate: a review of its use in alcohol withdrawal ...
Results of randomized controlled trials indicate that sodium oxybate was at least as effective as diazepam and clomethiazole in patients with alcohol withdrawal ...
Intravenous Acetate as an Adjunctive Treatment for Alcohol ...
intravenous (IV) acetate administration to participants with AUD was feasible and safe and had a demonstrable physiological effect on cerebral ...
4.
ema.europa.eu
ema.europa.eu/en/news/benefits-sodium-oxybate-continue-outweigh-risks-people-alcohol-dependencyBenefits of sodium oxybate continue to outweigh risks ... - EMA
the benefits of sodium oxybate syrup and oral solution (175 mg/ml) continue to outweigh their risks when used to treat acute alcohol withdrawal ...
Exogenous Acetate Formulations for Treating Alcohol Use ...
Upon abrupt cessation of alcohol intake, brain acetate levels drop, triggering neurological stress, cravings, and cognitive disturbances associated with ...
Benefits of sodium oxybate continue to outweigh risks ... - EMA
There are no new concerns about the safety of the medicines. If you are using a medicine containing sodium oxybate for acute alcohol withdrawal ...
Intravenous Acetate as an Adjunctive Treatment for Alcohol ...
This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive ...
Intravenous Acetate as an Adjunctive Treatment for Alcohol ...
intravenous (IV) acetate administration to participants with AUD was feasible and safe and had a demonstrable physiological effect on cerebral ...
Alcohol Withdrawal Syndrome - StatPearls - NCBI Bookshelf
This integrated model of care enhances patient safety and well-being while facilitating ongoing support and rehabilitation efforts, ultimately ...
View of Ethanol Infusion for Alcohol Withdrawal ...
Ethanol Infusion for Alcohol Withdrawal Prophylaxis Does Not Cause Intoxication. Serum ethanol levels increased in 12% of patients after administration of ...
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