Baclofen for the Treatment of Alcohol Drinkers

Last updated: October 2, 2017
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

2/3

Condition

Alcohol Use Disorder

Substance Abuse

Alcohol Dependence

Treatment

N/A

Clinical Study ID

NCT01604330
P110112
2011-005787-17
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient coming for a problem with alcohol (alcohol at high risk during the past threemonths (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 manmore than 60 g per day or 420 g per week or more than 60 g in once, and expressing thedesire 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 afterappropriate information

  • Patient having no treatment for the maintenance of abstinence (acamprosate,naltrexone) and the prevention of relapse (disulfiram) for at least 15 days before thebeginning of the trial

  • Patient informed about the possibility of drowsiness in relation to the treatment andthe associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiring attentionand precision

  • Including woman of childbearing age (but taking effective contraception).

Exclusion

Exclusion Criteria:

  • Patient taking already baclofen or having taken baclofen

  • Patient pregnant, lactating, or childbearing years in the absence of effectivecontraception

  • Patient with porphyria

  • Patient with Parkinson's disease

  • Patient with severe psychiatric pathology (psychosis, including schizophrenia andbipolar disorders) that can compromise the observance

  • Patient with organic disease serious enough to not to allow its inclusion in the studyaccording 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 thepresence of wheat starch

  • Patient with a severe intolerance known about the lactose

Study Design

Total Participants: 323
Study Start date:
May 29, 2012
Estimated Completion Date:
October 31, 2015

Study 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.

Connect with a study center

  • Paris Descartes University

    Paris, 75014
    France

    Site Not Available

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