NCT03788889

Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Phenobarbital and Ketamine Adjunctive Therapies in the Treatment of Alcohol Withdrawal Syndrome

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Santa Barbara Cottage Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to compare phenobarbital and ketamine adjunctive therapies to lorazepam-based therapy in the treatment of acute alcohol withdrawal syndrome. It is hypothesized that the use of an alternative agent, either phenobarbital or ketamine, when used as an adjunct to symptom-triggered lorazepam therapy will significantly reduce the rate of intensive care unit admissions and thereby reduce the total cost associated with hospital admission for treatment of alcohol withdrawal syndrome. Enrolled patients will be admitted to Santa Barbara Cottage Hospital where they will be monitored with continuous pulse oximetry and cardiac telemetry. They will remain hospitalized while undergoing study-guided therapy in addition to supportive care for acute alcohol withdrawal syndrome. Patients will undergo standard of care therapy with lorazepam symptom-triggered therapy regardless of study participation.

Conditions

• Alcohol Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine infusion
DRUG	Phenobarbital	Phenobarbital intravenous injection
DRUG	Lorazepam	Standard of Care
DRUG	Placebo A	Placebo injection
DRUG	Placebo B	Placebo infusion

Timeline

• Start date: 2019-04-12
• Primary completion: 2019-04-12
• Completion: 2019-04-12
• First posted: 2018-12-28
• Last updated: 2019-09-19

Regulatory

• FDA-regulated drug study