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

NCT ID: NCT00523185

Last Updated: 2007-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Alcohol Withdrawal

Keywords

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alcohol withdrawal lorazepam diazepam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

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

Interventions

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Lorazepam

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Ativan Valium

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Principal Investigators

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Jose R Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Palo Alto Veterans Affairs Hospital System

Palo Alto, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22898443 (View on PubMed)

Other Identifiers

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77757

Identifier Type: -

Identifier Source: org_study_id