Treatment of Alcohol Withdrawal in Hospital Patients

Study Overview
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Brief Summary
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The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.

Detailed Description
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Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.

Official Title
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Acute Drug Withdrawal in a General Medical Setting

Conditions
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Alcohol Withdrawal Syndrome

Intervention / Treatment
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* Drug: Lorazepam (drug)
* Drug: Lorazepam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment Patients on the General Internal Medicine service Exclusion Criteria: Unable to give informed consent Chronically maintained on prescription sedative-hypnotics

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed-schedule treatment<br>Fixed-schedule administration of lorazepam for alcohol withdrawal | Drug: Lorazepam (drug)<br>* Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients<br>* Other names: Ativan;Drug: Lorazepam<br>* Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients<br>* Other names: Ativan;|
| Active Comparator: Symptom-triggered treatment<br>Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar) | Drug: Lorazepam (drug)<br>* Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients<br>* Other names: Ativan;Drug: Lorazepam<br>* Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients<br>* Other names: Ativan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal Assessment Scores | Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms | participants were followed for the duration of hospital stay, the median length of stay was 3 days | 
| Total Dose of Lorazepam | Differences in total amount of lorazepam administered between protocol groups | participants were followed for the duration of hospital stay, the median length of stay was 3 days | 
| Protocol Errors | Percentage of protocol errors between study arms, such as administration of an inappropriate lorazepam dose (inconsistent with CIWA-Ar score); excluded complications due to comorbid medical conditions. | participants were followed for the duration of hospital stay, the median length of stay was 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)