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Completed

NCT Number: NCT00249366

Treatment of Alcohol Withdrawal in Hospital Patients

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.

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Key information

Conditions

Alcohol Withdrawal Syndrome

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorazepam (drug)

Drug

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Other names: Ativan

Lorazepam

Drug

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Other names: Ativan

Primary outcomes

  1. Withdrawal Assessment Scores

    Time frame: 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

  2. Total Dose of Lorazepam

    Time frame: 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

  3. Protocol Errors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Acute Drug Withdrawal in a General Medical Setting

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Nov 7, 2005
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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