Treatment of Alcohol Withdrawal in Hospital Patients

Phase 4

Completed

• Conditions: Alcohol Withdrawal Syndrome
• Interventions: Drug: Lorazepam (drug); Drug: Lorazepam

• Registration Number: NCT00249366
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptom-triggered treatment	Lorazepam (drug)	Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
Fixed-schedule treatment	Lorazepam (drug)	Fixed-schedule administration of lorazepam for alcohol withdrawal
Fixed-schedule treatment	Lorazepam	Fixed-schedule administration of lorazepam for alcohol withdrawal
Symptom-triggered treatment	Lorazepam	Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)

Primary Outcome Measures

Name	Time	Method
Total Dose of Lorazepam	participants were followed for the duration of hospital stay, the median length of stay was 3 days	Differences in total amount of lorazepam administered between protocol groups
Protocol Errors	participants were followed for the duration of hospital stay, the median length of stay was 3 days	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.
Withdrawal Assessment Scores	participants were followed for the duration of hospital stay, the median length of stay was 3 days	Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms

Trial Locations

Locations (1)

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States