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Treatment of Alcohol Withdrawal in Hospital Patients

Primary Purpose

Alcohol Withdrawal Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lorazepam (drug)
Lorazepam
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Withdrawal Syndrome focused on measuring Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fixed-schedule treatment

Symptom-triggered treatment

Arm Description

Fixed-schedule administration of lorazepam for alcohol withdrawal

Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)

Outcomes

Primary Outcome Measures

Withdrawal Assessment Scores
Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms
Total Dose of Lorazepam
Differences in total amount of lorazepam administered between protocol groups
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2005
Last Updated
April 8, 2016
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00249366
Brief Title
Treatment of Alcohol Withdrawal in Hospital Patients
Official Title
Acute Drug Withdrawal in a General Medical Setting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal Syndrome
Keywords
Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed-schedule treatment
Arm Type
Active Comparator
Arm Description
Fixed-schedule administration of lorazepam for alcohol withdrawal
Arm Title
Symptom-triggered treatment
Arm Type
Active Comparator
Arm Description
Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
Intervention Type
Drug
Intervention Name(s)
Lorazepam (drug)
Other Intervention Name(s)
Ativan
Intervention Description
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Primary Outcome Measure Information:
Title
Withdrawal Assessment Scores
Description
Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms
Time Frame
participants were followed for the duration of hospital stay, the median length of stay was 3 days
Title
Total Dose of Lorazepam
Description
Differences in total amount of lorazepam administered between protocol groups
Time Frame
participants were followed for the duration of hospital stay, the median length of stay was 3 days
Title
Protocol Errors
Description
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.
Time Frame
participants were followed for the duration of hospital stay, the median length of stay was 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F. Weaver, MD
Organizational Affiliation
Virginia Commonwealth University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16785215
Citation
Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03.
Results Reference
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Treatment of Alcohol Withdrawal in Hospital Patients

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