Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Proportion of abstainer patients and patients with a low risk consumption
研究概览
简要总结
The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.
详细描述
Baclofen, a gamma-aminobutyric acid 'B-receptor' agonist, has long been used to treat spasticity from neurological diseases, at a dose of 30-90 mg/day. It appears today to be a promising but controversial candidate for treating alcoholic patients (Enserick, 2011) by reducing or even suppressing their craving to drink. A few case reports (Ameisen, 2005; Bucknam, 2007; Dore et al., 2011) and a retrospective study (Rigal et al, 2012) suggest that some patients might respond favorably to baclofen at higher doses than 90 mg/day. This is a randomized controlled trial versus placebo testing such doses.
An extraction of patients DNA and a genetic analysis will be done after the end of the trial. In a gene candidate approach, the association of several genes with the efficiency of the treatment and its side effects, based on the literature, will be investigated using micro-array technology.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient coming for a problem with alcohol (alcohol at high risk during the past three months (at least two times during each month) according to the WHO standards;. i.e.: in women more than 40 g per day or 280 g per week or more of 40 g at once; the man more than 60 g per day or 420 g per week or more than 60 g in once, and expressing the desire to be abstinent or to have a consumption to low level of risk).
- •Volunteer to participate in the trial and having given his consent written after appropriate information
- •Patient having no treatment for the maintenance of abstinence (acamprosate, naltrexone) and the prevention of relapse (disulfiram) for at least 15 days before the beginning of the trial
- •Patient informed about the possibility of drowsiness in relation to the treatment and the associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiring attention and precision
- •Including woman of childbearing age (but taking effective contraception).
排除标准
- •Patient taking already baclofen or having taken baclofen
- •Patient pregnant, lactating, or childbearing years in the absence of effective contraception
- •Patient with porphyria
- •Patient with Parkinson's disease
- •Patient with severe psychiatric pathology (psychosis, including schizophrenia and bipolar disorders) that can compromise the observance
- •Patient with organic disease serious enough to not to allow its inclusion in the study according to the opinion of the investigator
- •Patient homeless
- •Patient without social cover
- •Patient unable to properly follow-up book, cannot commit to one year of follow-up
- •Patient with a contraindication to taking baclofen (intolerance to gluten by the presence of wheat starch
- •Patient with a severe intolerance known about the lactose
研究组 & 干预措施
Baclofen
Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.
干预措施: Baclofen (Drug)
Placebo
Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of abstainer patients and patients with a low risk consumption
时间窗: 12 months after the initiation of treatment
Low risk consumption according to the criteria of WHO (World Health Organization). The assessment will be on the declarative of the patient (with autoquestionnaire). It will be compared between the two groups using a Chi-2 test.
次要结局
- Evolution of patients under treatment(12 months after the initiation of treatment)
- To evaluate the tolerance of baclofen(12 months after the initiation of treatment)
- To better characterize the alcoholic patients in whom this molecule is effective(12 months after the initiation of treatment)
- Distribution of Efficience dosage of baclofen(12 months after the initiation of treatment)
- Cumulative quantity of alcohol drunk in the last month(12 months after the initiation of treatment)
- Quality of life during treatment(at Day 1 and 12 months after the initiation of treatment)
- Evolution of biology(At day one, 6 months and 12 months after the initiation of treatment)