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

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ClinicalTrials.gov Identifier: NCT00523185
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Sponsor:
Information provided by:
Stanford University

August 29, 2007
August 31, 2007
August 31, 2007
May 2003
Not Provided
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 ]
Same as current
No Changes Posted
Secondary outcome measures include total benzodiazepine use. [ Time Frame: one to two weeks ]
Same as current
Not Provided
Not Provided
 
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
The purpose of this study is to compare the efficacy of two commonly used medications in the treatment of alcohol withdrawal, diazepam and lorazepam.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alcohol Withdrawal
  • Drug: Lorazepam
    Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
    Other Name: Ativan
  • 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: 2
    Intervention: Drug: Diazepam
  • Active Comparator: 1
    Intervention: Drug: Lorazepam
Maldonado JR, Nguyen LH, Schader EM, Brooks JO 3rd. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial. Gen Hosp Psychiatry. 2012 Nov-Dec;34(6):611-7. doi: 10.1016/j.genhosppsych.2012.06.016. Epub 2012 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
Same as current
November 2004
Not Provided

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00523185
77757
Yes
Not Provided
Not Provided
Not Provided
Stanford University
Not Provided
Principal Investigator: Jose R Maldonado, MD Stanford University
Stanford University
August 2007

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