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WithdrawnPhase 4

Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

NCT03788889 · PKAT · Santa Barbara Cottage Hospital

Closed to entry
Status
Not accepting participants
Phase 4
Phase
Target enrolment
Study sites

What it is testing

Summary

The goal of this study will aim to determine if adding phenobarbital or ketamine to a symptom-triggered benzodiazepine regimen decreases the rate of intensive care unit admissions during the treatment of alcohol withdrawal syndrome when compared to symptom-triggered benzodiazepine therapy alone.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Intensive Care Unit admission rate

    Measured over Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Primary admitting diagnosis of acute alcohol withdrawal syndrome based on International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), code F10.3, F10.4. Exclusion Criteria: * Significant comorbid medical illness requiring Intensive Care Unit admission; * Pregnancy; * Inability to obtain intravenous access; * Child Pugh Class C; and * Allergy to study medications (phenobarbital, ketamine, lorazepam).

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03788889 on ClinicalTrials.gov →

Last updated in the registry 2019-09-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance