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

August 29, 2007 updated by: Stanford University
The purpose of this study is to compare the efficacy of two commonly used medications in the treatment of alcohol withdrawal, diazepam and lorazepam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto Veterans Affairs Hospital System
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: one to two weeks
one to two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome measures include total benzodiazepine use.
Time Frame: one to two weeks
one to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

August 31, 2007

Last Update Submitted That Met QC Criteria

August 29, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77757

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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