Phenobarbital for Acute Alcohol Withdrawal

Alcohol Withdrawal Clinical Trial

Official title:

Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184417
• Other study ID #: AlamedaCountyMC
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: March 7, 2012
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Alameda County Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board ACMC (for Oversight Authority)**Note: This study was approved by the ACMC Ethics committee in conjunction with the ACMC IRB.
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Withdrawal

Intervention

Drug:
• 10 mg/kg IV phenobarbital in 100 ml saline
10 mg/kg IV phenobarbital in 100 ml saline
• placebo
100 m l saline

Locations

Country	Name	City	State
United States	Alameda County Medical Center	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonathan Rosenson	Alameda County Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Percentage of Patients Requiring ICU Admission	admission to intensive care unit	1 year	No
Primary	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	No
Secondary	Length of Stay	hospital LOS, per patient, in hours from admission to discharge	1 year	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Number of Study Patients With Mortality as a Measure of Safety and Tolerability	mortality in study patients	1 year	Yes