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Treatment of Alcohol Withdrawal in Hospital Patients

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ClinicalTrials.gov Identifier: NCT00249366
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Virginia Commonwealth University

November 3, 2005
November 7, 2005
April 11, 2016
April 2001
May 2003   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • 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.
  • Difference in withdrawal assessment scores
  • Total Dose of Lorazepam
  • Protocol Errors
Complete list of historical versions of study NCT00249366 on ClinicalTrials.gov Archive Site
Not Provided
  • Protocol acceptability to nurses
  • Protocol acceptability to physicians
  • Inpatient length of stay
Not Provided
Not Provided
 
Treatment of Alcohol Withdrawal in Hospital Patients
Acute Drug Withdrawal in a General Medical Setting
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Alcohol Withdrawal Syndrome
  • Drug: Lorazepam (drug)
    Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
    Other Name: Ativan
  • Drug: Lorazepam
    Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
    Other Name: Ativan
  • Active Comparator: Fixed-schedule treatment
    Fixed-schedule administration of lorazepam for alcohol withdrawal
    Interventions:
    • Drug: Lorazepam (drug)
    • Drug: Lorazepam
  • Active Comparator: Symptom-triggered treatment
    Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
    Interventions:
    • Drug: Lorazepam (drug)
    • Drug: Lorazepam
Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
Same as current
May 2003
May 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00249366
NIAAAWEA-K2300222-A
K23AA000222 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Michael F. Weaver, MD Virginia Commonwealth University Medical Center
Virginia Commonwealth University
April 2016

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