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

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00523185

Purpose

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	Intervention
Alcohol Withdrawal	Drug: Lorazepam Drug: Diazepam

Drug Information available for: Diazepam Lorazepam Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	55
Study Start Date:	May 2003
Study Completion Date:	November 2004

Arms	Assigned Interventions
2: Active Comparator	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.
1: Active Comparator	Drug: Lorazepam Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523185

Locations

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

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Jose R Maldonado, MD

Stanford University

More Information

Study ID Numbers:	77757
Study First Received:	August 29, 2007
Last Updated:	August 29, 2007
ClinicalTrials.gov Identifier:	NCT00523185
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

alcohol withdrawal
lorazepam
diazepam

Study placed in the following topic categories:

Lorazepam
Diazepam
Ethanol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Anesthetics
Antiemetics
Central Nervous System Depressants
Neuromuscular Agents

Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Autonomic Agents
Therapeutic Uses
Muscle Relaxants, Central
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009