Treatment of Alcohol Withdrawal in Hospital Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00249366
First received: November 3, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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
Acute Alcohol Withdrawal Syndrome
Drug: Lorazepam (drug)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Difference in withdrawal assessment scores
  • Total dose of lorazepam
  • Protocol errors

Secondary Outcome Measures:
  • Protocol acceptability to nurses
  • Protocol acceptability to physicians
  • Inpatient length of stay

Estimated Enrollment: 183
Study Start Date: April 2001
Estimated Study Completion Date: May 2003
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
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
Investigators
Principal Investigator: Michael F. Weaver, MD Virginia Commonwealth University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249366     History of Changes
Other Study ID Numbers: NIAAAWEA-K2300222-A, NIH Grant K23 AA00222
Study First Received: November 3, 2005
Last Updated: November 3, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol withdrawal
Symptom-triggered therapy
Fixed-schedule therapy
Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar)
Lorazepam (drug)

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 19, 2014