Treatment of Alcohol Withdrawal in Hospital Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 3, 2005

Last Updated Date

November 3, 2005

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Difference in withdrawal assessment scores
Total dose of lorazepam
Protocol errors

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Protocol acceptability to nurses
Protocol acceptability to physicians
Inpatient length of stay

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Alcohol Withdrawal in Hospital Patients

Official Title ^ICMJE

Acute Drug Withdrawal in a General Medical Setting

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Acute Alcohol Withdrawal Syndrome

Intervention ^ICMJE

Drug: Lorazepam (drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

183

Completion Date

May 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00249366

Responsible Party

Study ID Numbers ^ICMJE

NIAAAWEA-K2300222-A, NIH Grant K23 AA00222

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael F. Weaver, MD

Virginia Commonwealth University Medical Center

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP