Acute Drug Withdrawal in a General Medical Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Total Dose of Lorazepam
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to give informed consent
- •Chronically maintained on prescription sedative-hypnotics
研究组 & 干预措施
Fixed-schedule treatment
Fixed-schedule administration of lorazepam for alcohol withdrawal
干预措施: Lorazepam (drug) (Drug)
Fixed-schedule treatment
Fixed-schedule administration of lorazepam for alcohol withdrawal
干预措施: Lorazepam (Drug)
Symptom-triggered treatment
Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
干预措施: Lorazepam (drug) (Drug)
Symptom-triggered treatment
Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
干预措施: Lorazepam (Drug)
结局指标
主要结局
Total Dose of Lorazepam
时间窗: 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
时间窗: 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.
Withdrawal Assessment Scores
时间窗: 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
次要结局
未报告次要终点