Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
研究概览
简要总结
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
详细描述
The objective of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Patients and Methods:
This study is a prospective analysis of patients admitted to a medical outpatient clinic between August 25, 2003 and July 1, 2006, who experienced AWS. This study is conducted at Copenhagen Hospital Corporation in Copenhagen, Denmark. Patients were divided into two randomized groups: a symptom-triggered treatment versus a fixed-schedule treatment (known) with chlordiazepoxide. They were diagnosed with AWS according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). They were diagnosed with alcohol dependence according to the ICD-10 (International Statistical Classification of Diseases and Health Related Problems).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above the age of 18
- •Fulfilled informed consent
- •Abstained from alcohol within the last 72 hours.
- •Agree on both treatment regimens.
- •Abstinence during 10 days (monitoring and medication period), i.e. treatment with disulfiram or oral alcometer test on every attendance (Lion Alcometer S-D2).
排除标准
- •Oral alcoholmeter test > 0.
- •Treatment of AWS within the last week
- •3 earlier attempts at outpatient detoxification within the last 2 months without success.
- •Allergy or adverse reactions to chlordiazepoxide
- •Treatment with medication in interaction with chlordiazepoxide
- •Psychiatric comorbidity within the last year, dependence on other drugs except nicotine dependence
- •Medically severe comorbidity, especially severe liver insufficiency
- •Severe cardiovascular diseases, NIDDM and IDDM.
- •A history within the last year of seizures and delirium tremens.
- •Patients should be cooperative in terms of cooperation and understanding of the Danish language.
- •Females of fertile age without safe contraception, (i.e. IUD, hormone tablets or sterilisation) also pregnant or breastfeeding women were excluded.
结局指标
主要结局
To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
Use of medication
AWS score day 1, 2, 3, etc.
Wellbeing
Patient satisfaction
次要结局
- Compliance in alcohol treatment
- Time to first relapse