Baclofen for the Treatment of Alcohol Drinkers (NCT01604330) | Clinical Trial Compass
CompletedPhase 2/3
Baclofen for the Treatment of Alcohol Drinkers
France323 participantsStarted 2012-05-29
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 …
What they're measuring
1
Proportion of abstainer patients and patients with a low risk consumption
Timeframe: 12 months after the initiation of treatment