Phenobarbital for Acute Alcohol Withdrawal

Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Study Overview

• Status: Completed
• Conditions: Alcohol Withdrawal
• Intervention / Treatment: Drug: 10 mg/kg IV phenobarbital in 100 ml saline; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94608
      • Alameda County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

• allergy to phenobarbital, lorazepam, age<18 or >65

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenobarbital group; 10 mg/kg IV phenobarbital in 100 ml saline	Drug: 10 mg/kg IV phenobarbital in 100 ml saline; 10 mg/kg IV phenobarbital in 100 ml saline
Placebo Comparator: Placebo group; 100 ml saline	Drug: placebo; 100 m l saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Requiring Continuous Lorazepam Infusion	All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).	1 year
Percentage of Patients Requiring ICU Admission	admission to intensive care unit	1 year
Total Lorazepam Required Per Patient Per Admission	How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	hospital LOS, per patient, in hours from admission to discharge	1 year
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability	The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.	1 year
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability	Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.	1 year
Number of Study Patients With Seizure as a Measure of Safety and Tolerability	Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).	1 year
Number of Study Patients With Mortality as a Measure of Safety and Tolerability	mortality in study patients	1 year

Collaborators and Investigators

• Sponsor: Jonathan Rosenson
• Collaborators: Alameda County Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): March 9, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Phenobarbital
• Other Study ID Numbers: AlamedaCountyMC