Clincosm LogoSign in Get a demo

A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00523185
Collaborator
(none)
55
Enrollment
2
Locations
2
Arms
18.1
Duration (Months)
27.5
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of two commonly used medications in the treatment of alcohol withdrawal, diazepam and lorazepam.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Despite the frequent use of benzodiazepines for the treatment of alcohol withdrawal, studies comparing the efficacy of long and short half-life benzodiazepines in the treatment of alcohol withdrawal have shown mixed results. Due to the conflicting nature of published reports, clinicians have no clear indication as to which type of agent is preferable. The purpose of this study is to compare the efficacy of two commonly accepted medications in the treatment of alcohol withdrawal, diazepam and lorazepam, which are long and short half-life benzodiazepines, respectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
Study Start Date :
May 1, 2003
Actual Study Completion Date :
Nov 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

Drug: Diazepam
Diazepam 20 mg by mouth every two hours x 3 doses, or for parenteral treatment, diazepam 10 mg intravenously every one hour x 6 doses. Give additional diazepam 10 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
Other Names:
  • Valium

    		•
    Active Comparator: 1

    Drug: Lorazepam
    Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
    Other Names:
  • Ativan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome measures include serial measures of vital signs and scores on the Clinical Institute Withdrawal Assessment for Alcohol-Revised scale (CIWA-Ar), a widely used scale that monitors alcohol withdrawal symptoms. [one to two weeks]

    Secondary Outcome Measures

    1. Secondary outcome measures include total benzodiazepine use. [one to two weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of alcohol withdrawal

    • History of alcohol use within 24 hours

    • Ability to consent to participate in the study

    Exclusion Criteria:

    • Unwillingness to participate in the study

    • Active abuse of other CNS depressants

    • Acute intoxication with a CNS activating agent

    • Severe hepatic dysfunction

    • Pregnancy

    • History of dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palo Alto Veterans Affairs Hospital System Palo Alto California United States 94304
    2 Stanford Hospital and Clinics Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Jose R Maldonado, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00523185
    Other Study ID Numbers:
    • 77757
    First Posted:
    Aug 31, 2007
    Last Update Posted:
    Aug 31, 2007
    Last Verified:
    Aug 1, 2007
    Keywords provided by , ,
    alcohol withdrawal
    lorazepam
    diazepam
    Additional relevant MeSH terms:
    Diazepam
    Lorazepam

    Study Results

    No Results Posted as of Aug 31, 2007