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Treatment of Alcohol Withdrawal in Hospital Patients

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00249366
First received: November 3, 2005
Last updated: April 8, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Alcohol Withdrawal Syndrome
Drug: Lorazepam (drug)
Drug: Lorazepam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acute Drug Withdrawal in a General Medical Setting

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Withdrawal Assessment Scores [ Time Frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 183
Study Start Date: April 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ativan
Drug: Lorazepam
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: 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 Name: Ativan
Drug: Lorazepam
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: Ativan

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.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249366

Locations
United States, Virginia
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
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00249366     History of Changes
Other Study ID Numbers: NIAAAWEA-K2300222-A  K23AA000222 
Study First Received: November 3, 2005
Last Updated: April 8, 2016
Health Authority: United States: Federal Government

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
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Lorazepam
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016