Clincosm LogoSign in Get a demo

Treatment of Alcohol Withdrawal in Hospital Patients

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT00249366
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
183
Enrollment
1
Location
2
Arms
25
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Acute Drug Withdrawal in a General Medical Setting
Study Start Date :
Apr 1, 2001
Actual Primary Completion Date :
May 1, 2003
Actual Study Completion Date :
May 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fixed-schedule treatment

Fixed-schedule administration of lorazepam for alcohol withdrawal

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

    • Drug: Lorazepam
    Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
    Other Names:
  • Ativan

    		•
    Active Comparator: Symptom-triggered treatment

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

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

    • Drug: Lorazepam
    Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
    Other Names:
  • Ativan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Withdrawal Assessment Scores [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Medical Center Richmond Virginia United States 23219

    Sponsors and Collaborators

    • Virginia Commonwealth University
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Michael F. Weaver, MD, Virginia Commonwealth University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT00249366
    Other Study ID Numbers:
    • NIAAAWEA-K2300222-A
    • K23AA000222
    First Posted:
    Nov 7, 2005
    Last Update Posted:
    Apr 11, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Virginia Commonwealth University
    Alcohol withdrawal
    Symptom-triggered therapy
    Fixed-schedule therapy
    CIWA-Ar
    Lorazepam (drug)
    Additional relevant MeSH terms:
    Substance Withdrawal Syndrome
    Lorazepam

    Study Results

    No Results Posted as of Apr 11, 2016