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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00523185
First received: August 29, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

Resource links provided by NLM:


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
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 Name: 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 Name: Ativan

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Palo Alto Veterans Affairs Hospital System
Palo Alto, California, United States, 94304
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jose R Maldonado, MD Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00523185     History of Changes
Other Study ID Numbers: 77757
Study First Received: August 29, 2007
Last Updated: August 29, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
alcohol withdrawal
lorazepam
diazepam

Additional relevant MeSH terms:
Ethanol
Diazepam
Lorazepam
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on July 24, 2014