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Treatment of Alcohol Withdrawal in Hospital Patients

Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Alcohol Withdrawal Syndrome

Intervention: Lorazepam (drug) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Michael F. Weaver, MD, Principal Investigator, Affiliation: Virginia Commonwealth University Medical Center

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.

Clinical Details

Official title: Acute Drug Withdrawal in a General Medical Setting

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

Difference in withdrawal assessment scores

Total dose of lorazepam

Protocol errors

Secondary outcome:

Protocol acceptability to nurses

Protocol acceptability to physicians

Inpatient length of stay

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.

Eligibility

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Virginia Commonwealth University Medical Center, Richmond, Virginia 23219, United States
Additional Information

Starting date: April 2001
Last updated: November 3, 2005

Page last updated: August 23, 2015

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