Clinical trial NCT01604330: Baclofen for the Treatment of Alcohol Drinkers
Official title: Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcoholism
Keywords: High dose baclofen
Alcoholism
Abstinence
Low risk consumption
Craving
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Société de Formation Thérapeutique du Généraliste
name: Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist
First posted: 2012-05-23
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of abstainer patients and patients with a low risk consumption
timeFrame: 12 months after the initiation of treatment
Secondary outcomes:
measure: Distribution of Efficience dosage of baclofen
timeFrame: 12 months after the initiation of treatment
measure: To evaluate the tolerance of baclofen
timeFrame: 12 months after the initiation of treatment
measure: To better characterize the alcoholic patients in whom this molecule is effective
timeFrame: 12 months after the initiation of treatment
measure: Evolution of patients under treatment
timeFrame: 12 months after the initiation of treatment
measure: Cumulative quantity of alcohol drunk in the last month
timeFrame: 12 months after the initiation of treatment
measure: Quality of life during treatment
timeFrame: at Day 1 and 12 months after the initiation of treatment
measure: Evolution of biology
timeFrame: At day one, 6 months and 12 months after the initiation of treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Descartes University
Study officials:
affiliation: University of Paris 5 - Rene Descartes
name: Philippe Jaury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.