Baclofen for the Treatment of Alcohol Drinkers

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist; Société de Formation Thérapeutique du Généraliste
• Treatments: Baclofen

Criteria

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 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