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

Study Overview
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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.

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

Conditions
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Alcohol Withdrawal

Intervention / Treatment
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* Drug: Lorazepam
* Drug: Diazepam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br> | Drug: Diazepam<br>* 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.<br>* Other names: Valium;|
| Active Comparator: 1<br> | Drug: Lorazepam<br>* Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.<br>* Other names: Ativan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | one to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures include total benzodiazepine use. |  | one to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol withdrawal, lorazepam, diazepam