Baclofen for the Treatment of Alcohol Drinkers (BACLOVILLE)

August 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Paris Descartes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of abstainer patients and patients with a low risk consumption
Time Frame: 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.
12 months after the initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Efficience dosage of baclofen
Time Frame: 12 months after the initiation of treatment
Published studies indicate that the average dose would be about 140 mg per day without, a priori, report with the weight of the patient. Animal studies show an optimal dose of 3 mg/kg.
12 months after the initiation of treatment
To evaluate the tolerance of baclofen
Time Frame: 12 months after the initiation of treatment
To try, if possible, to differentiate which is due to the molecule, which is due to the stop of drinking alcohol and which is due to the alcohol-baclofen potentiation and looking for all the side effects including at high dosages.
12 months after the initiation of treatment
To better characterize the alcoholic patients in whom this molecule is effective
Time Frame: 12 months after the initiation of treatment
By using the anxiety/depression HAD scale. By using the scale of craving (Obsessive Compulsive Drinking Scale). By using the DSM - IV for the dependency.
12 months after the initiation of treatment
Evolution of patients under treatment
Time Frame: 12 months after the initiation of treatment

At each consultation, the consumption self-assessment questionnaire is analysed with the patient (book of follow-up) and missing data are sought and completed.

To describe the evolution of patients under treatment from the point of view of the total consumption of alcohol, the monthly average consumption, the number of days of abstinence, the number of "heavy drinking days".
12 months after the initiation of treatment
Cumulative quantity of alcohol drunk in the last month
Time Frame: 12 months after the initiation of treatment
To analyse the cumulative quantity of alcohol drunk by the patient during the last month of treatment
12 months after the initiation of treatment
Quality of life during treatment
Time Frame: at Day 1 and 12 months after the initiation of treatment
To assess the quality of life during treatment by using the scale SF36 at the beginning and at the end of the study.
at Day 1 and 12 months after the initiation of treatment
Evolution of biology
Time Frame: At day one, 6 months and 12 months after the initiation of treatment
To study the evolution of biology, including liver, compared to the declaration made by the patient from his response to treatment. Biological examinations will be performed at the beginning, at 6 month and at the end of the trial.
At day one, 6 months and 12 months after the initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Société de Formation Thérapeutique du Généraliste
Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist
Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Principal Investigator: Philippe Jaury, MD, PhD, University of Paris 5 - Rene Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimated)

May 23, 2012

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110112
  • 2011-005787-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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