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Treatment of Alcohol Withdrawal in Hospital Patients
This study has been completed.
Sponsor:
Virginia Commonwealth University
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
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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 Intervention Model: Parallel Assignment Masking: Single Blind (Participant) 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 ]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.
| 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) |
| 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
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
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 ( U.S. NIH Grant/Contract ) |
| Study First Received: | November 3, 2005 |
| Last Updated: | April 8, 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 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 July 24, 2017