Baclofen Bij de Behandeling Van Acute Alcoholontwenning
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Need for additional diazepam
研究概览
简要总结
The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.
详细描述
The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
- •Be able to sign informed consent.
- •Be male/female aged 18-60
- •Primary diagnosis of alcohol use disorder.
排除标准
- •Pregnancy and breastfeeding.
- •Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
- •Psychosis, confusion and acute mania.
- •Parkinson's disease.
- •Use of tricyclic antidepressants.
- •Use of opioids.
- •Known baclofen or benzodiazepine sensitivity or allergy.
- •Unable to take oral medication.
- •epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake).
- •Prior diagnosis of epilepsy.
- •Lactose intolerance.
研究组 & 干预措施
Baclofen 30 mg/day
baclofen 30 mg/day
干预措施: Diazepam 10 MG (Drug)
Baclofen 30 mg/day
baclofen 30 mg/day
干预措施: Baclofen 30mg (Drug)
Baclofen 60 mg/day
干预措施: Diazepam 10 MG (Drug)
Baclofen 60 mg/day
干预措施: Baclofen 60mg (Drug)
Placebo
干预措施: Diazepam 10 MG (Drug)
结局指标
主要结局
Need for additional diazepam
时间窗: Measured 7 days after the start of alcohol withdrawal
Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal
次要结局
- Dosage of additional diazepam needed(Measured 7 days after the start of alcohol withdrawal)