Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Moderate or Severe Alcohol Withdrawal Syndrome
研究概览
简要总结
The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
- •Patient placed on AWS watch protocol by admitting physicians.
排除标准
- •Unable to provide informed consent
- •Unable to take swallow oral medications (tube-fed patients are to be excluded)
- •Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score >8 at baseline
- •No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline
- •Baclofen use at baseline
- •Baclofen sensitivity
- •Hospital discharge anticipated in within 48 hours
- •Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)
- •Other active drug dependence (except tobacco)
研究组 & 干预措施
Placebo
Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
干预措施: Placebo (Drug)
Baclofen
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
干预措施: Baclofen (Drug)
结局指标
主要结局
Moderate or Severe Alcohol Withdrawal Syndrome
时间窗: 72 hours
Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
次要结局
- Peak and Total Benzodiazepine Dose Required(72 hours)
- Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment(72 hours)