Alcohol Withdrawal Syndrome
Conditions
Keywords
Alcohol withdrawal, Symptom-triggered therapy, Fixed-schedule therapy, CIWA-Ar, Lorazepam (drug)
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.
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.
Interventions
DRUGLorazepam (drug)
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
DRUGLorazepam
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Assessment Scores | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed