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

Alcohol Withdrawal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523185
• Other study ID #: 77757
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: August 29, 2007
• Start date: May 2003
• Est. completion date: November 2004

Study information

• Verified date: August 2007
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Withdrawal

Intervention

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

Locations

Country	Name	City	State
United States	Palo Alto Veterans Affairs Hospital System	Palo Alto	California
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome measures include total benzodiazepine use.		one to two weeks