Treatment of Alcohol Withdrawal in Hospital Patients

Alcohol Withdrawal Syndrome Clinical Trial

Official title:

Acute Drug Withdrawal in a General Medical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249366
• Other study ID #: NIAAAWEA-K2300222-A
• Secondary ID: K23AA000222
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2005
• Last updated: April 8, 2016
• Start date: April 2001
• Est. completion date: May 2003

Study information

• Verified date: April 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alcohol Withdrawal Syndrome
• Substance Withdrawal Syndrome

Intervention

Drug:
• Lorazepam (drug)
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
• Lorazepam
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes