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CompletedNCT00523185Updated Aug 31, 2007

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

An interventional study of Lorazepam and Diazepam in Alcohol Withdrawal, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2007-08-31.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcohol Withdrawal

Keywords

  • alcohol withdrawal
  • lorazepam
  • diazepam
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.

Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of alcohol withdrawal
  • History of alcohol use within 24 hours
  • Ability to consent to participate in the study

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Active comparator
    2

    Drug: Diazepam

  • Active comparator
    1

    Drug: Lorazepam

Interventions

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

    Also known as: Ativan

  • 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.

    Also known as: Valium

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Secondary outcome measures include total benzodiazepine use.

    Time frame: one to two weeks

07

Study locations

2 sites
  • Palo Alto Veterans Affairs Hospital System
    Palo Alto, California 94304, United States
  • Stanford Hospital and Clinics
    Stanford, California 94305, United States
08

References and documents

Publications

  • 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. PubMed 22898443 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2003 and a completion of Nov 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2007
First posted
Aug 31, 2007
Start
May 2003
CompletionActual
Nov 2004
Last update
Aug 31, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00523185
First posted
Aug 31, 2007
Start date
May 2003
Completion
Nov 2004
Last update
Aug 31, 2007

Study contacts

Jose R Maldonado, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Lorazepam · Diazepam

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