Skip to content
WithdrawnPhase 4

Ketamine vs. Placebo as Adjunctive Therapies for Severe Alcohol Withdrawal

NCT02823977 · University of Colorado, Denver

Closed to entry
Status
Not accepting participants
Phase 4
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study is designed to evaluate the addition of ketamine to dexmedetomidine as adjunctive therapies of severe alcohol withdrawal in medical ICU patients. Specifically, this study will assess whether the combination of ketamine and dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if the combination alters the expression of catecholamines in the serum over time.

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

  • Cumulative Lorazepam Dose Over the First 12 Hours of Alcohol Withdrawal

    Measured over 12 hours

  • Cumulative Lorazepam Dose Over the First 24 Hours of Alcohol Withdrawal

    Measured over 24 hours

  • Cumulative Lorazepam Dose Over the 72 Hours of Alcohol Withdrawal

    Measured over 72 hours

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 to 85 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam equivalents over a four-hour period. All benzodiazepine and barbiturate doses, whether oral or intravenous, will contribute to the cumulative amount using the following conversion: 1 mg lorazepam = 2 mg midazolam = 7.5 mg clorazepate = 15 mg phenobarbital. 2. Patients receiving standard therapy for severe alcohol withdrawal according to the UCH-specific, symptom-triggered alcohol withdrawal protocol in the ICU (or admission to the ICU is anticipated). Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal. 3. Informed consent within 36 hours of qualifying for the study. Exclusion Criteria: 1. Patients \< 18 years of age or \> 85 years of age. 2. Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation, seizure control other than alcohol withdrawal). 3. Patients with alcohol withdrawal not requiring ICU admission. 4. Patients receiving epidural administration of medication(s). 5. Comatose patients by metabolic or neurologic affectation. 6. Patients with active myocardial ischemia or second- or third-degree heart block. 7. Patients with Child-Pugh score of C. 8. Moribund state with planned withdrawal of life support. 9. Patient pending transfer to another facility. 10. Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine) or ketamine. 11. Pregnant females or females suspected of being pregnant. 12. Prisoners or active parolees. 13. Previous study participation. 14. Patients already receiving ketamine for alcohol withdrawal. Patients receiving dexmedetomidine will be excluded if the infusion exceeds 1 µg/kg per hour for more than two hours or any rate for a cumulative duration of 12 hours.

Where

1 study site

FacilityCityRegionCountry
University of Colorado HospitalAuroraColoradoUnited States

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.

NCT02823977 on ClinicalTrials.gov →

Last updated in the registry 2018-01-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits