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Phenobarbital for Acute Alcohol Withdrawal

This study has been completed.
Sponsor:
Collaborator:
Alameda County Medical Center
Information provided by (Responsible Party):
Jonathan Rosenson, Alameda County Medical Center
ClinicalTrials.gov Identifier:
NCT01184417
First received: August 17, 2010
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Alcohol Withdrawal
 Drug: 10 mg/kg IV phenobarbital in 100 ml saline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alameda County Medical Center:

Primary Outcome Measures:
  • Number of Patients Requiring Continuous Lorazepam Infusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).

  • Percentage of Patients Requiring ICU Admission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    admission to intensive care unit

  • Total Lorazepam Required Per Patient Per Admission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Length of Stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    hospital LOS, per patient, in hours from admission to discharge

  • Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Number of Study Patients With Seizure as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).

  • Number of Study Patients With Mortality as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    mortality in study patients


Enrollment: 102
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

  • allergy to phenobarbital, lorazepam, age<18 or >65
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184417

Locations
United States, California
Alameda County Medical Center
Oakland, California, United States, 94608
Sponsors and Collaborators
Jonathan Rosenson
Alameda County Medical Center
  More Information

No publications provided

Responsible Party: Jonathan Rosenson, Jonathan Rosenson MD, Alameda County Medical Center
ClinicalTrials.gov Identifier: NCT01184417     History of Changes
Other Study ID Numbers: AlamedaCountyMC
Study First Received: August 17, 2010
Results First Received: February 18, 2012
Last Updated: March 7, 2012
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.

Additional relevant MeSH terms:
Phenobarbital
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013