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Treatment of Alcohol Withdrawal in Hospital Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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
Alcohol Withdrawal Syndrome Drug: Lorazepam (drug) Drug: Lorazepam 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
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Study Type : Interventional  (Clinical Trial)
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 : April 2001
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249366


Locations
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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
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Principal Investigator: Michael F. Weaver, MD Virginia Commonwealth University Medical Center
More Information
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Publications of Results:

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00249366    
Other Study ID Numbers: NIAAAWEA-K2300222-A
K23AA000222 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Keywords provided by Virginia Commonwealth University:
Alcohol withdrawal
Symptom-triggered therapy
Fixed-schedule therapy
CIWA-Ar
Lorazepam (drug)
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action