A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal - Tabular View

Tracking Information

First Received Date ^ICMJE

August 29, 2007

Last Updated Date

August 29, 2007

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Secondary outcome measures include total benzodiazepine use. [ Time Frame: one to two weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Alcohol Withdrawal

Intervention ^ICMJE

Drug: Lorazepam
Drug: Diazepam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00523185

Responsible Party

Study ID Numbers ^ICMJE

77757

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jose R Maldonado, MD

Stanford University

Information Provided By

Stanford University

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP