Skip to main content
OpenTrials
Completed

NCT Number: NCT01184417

Phenobarbital 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Withdrawal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alameda County Medical Center

Oakland, California, 94608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Need for admission to hospital for acute alcohol withdrawal

Exclusion criteria

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

Treatment and study plan

10 mg/kg IV phenobarbital in 100 ml saline

Drug

10 mg/kg IV phenobarbital in 100 ml saline

Placebo

Drug

100 m l saline

Primary outcomes

  1. Number of Patients Requiring Continuous Lorazepam Infusion

    Time frame: 1 year

    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).

  2. Percentage of Patients Requiring ICU Admission

    Time frame: 1 year

    admission to intensive care unit

  3. Total Lorazepam Required Per Patient Per Admission

    Time frame: 1 year

    How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.

Secondary outcomes

  1. Length of Stay

    Time frame: 1 year

    hospital LOS, per patient, in hours from admission to discharge

  2. Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability

    Time frame: 1 year

    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.

  3. Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability

    Time frame: 1 year

    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.

  4. Number of Study Patients With Seizure as a Measure of Safety and Tolerability

    Time frame: 1 year

    Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).

  5. Number of Study Patients With Mortality as a Measure of Safety and Tolerability

    Time frame: 1 year

    mortality in study patients

Sponsors and collaborators

Lead sponsor

Jonathan Rosenson

Other

Collaborators

  • Alameda County Medical Center

Registry information

Official study title

Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 19, 2010
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.