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Baclofen for the Treatment of Alcohol Drinkers (BACLOVILLE)

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Baclofen
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring High dose baclofen, Alcoholism, Abstinence, Low risk consumption, Craving

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paris Descartes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baclofen

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of abstainer patients and patients with a low risk consumption
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.

Secondary Outcome Measures

Distribution of Efficience dosage of baclofen
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.
To evaluate the tolerance of baclofen
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.
To better characterize the alcoholic patients in whom this molecule is effective
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.
Evolution of patients under 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".
Cumulative quantity of alcohol drunk in the last month
To analyse the cumulative quantity of alcohol drunk by the patient during the last month of treatment
Quality of life during treatment
To assess the quality of life during treatment by using the scale SF36 at the beginning and at the end of the study.
Evolution of biology
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.

Full Information

First Posted
May 21, 2012
Last Updated
October 2, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Société de Formation Thérapeutique du Généraliste, Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist
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1. Study Identification

Unique Protocol Identification Number
NCT01604330
Brief Title
Baclofen for the Treatment of Alcohol Drinkers
Acronym
BACLOVILLE
Official Title
Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 29, 2012 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Société de Formation Thérapeutique du Généraliste, Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
High dose baclofen, Alcoholism, Abstinence, Low risk consumption, Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baclofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of abstainer patients and patients with a low risk consumption
Description
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.
Time Frame
12 months after the initiation of treatment
Secondary Outcome Measure Information:
Title
Distribution of Efficience dosage of baclofen
Description
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.
Time Frame
12 months after the initiation of treatment
Title
To evaluate the tolerance of baclofen
Description
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.
Time Frame
12 months after the initiation of treatment
Title
To better characterize the alcoholic patients in whom this molecule is effective
Description
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.
Time Frame
12 months after the initiation of treatment
Title
Evolution of patients under treatment
Description
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".
Time Frame
12 months after the initiation of treatment
Title
Cumulative quantity of alcohol drunk in the last month
Description
To analyse the cumulative quantity of alcohol drunk by the patient during the last month of treatment
Time Frame
12 months after the initiation of treatment
Title
Quality of life during treatment
Description
To assess the quality of life during treatment by using the scale SF36 at the beginning and at the end of the study.
Time Frame
at Day 1 and 12 months after the initiation of treatment
Title
Evolution of biology
Description
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.
Time Frame
At day one, 6 months and 12 months after the initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Jaury, MD, PhD
Organizational Affiliation
University of Paris 5 - Rene Descartes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paris Descartes University
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33012365
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.
Results Reference
derived

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Baclofen for the Treatment of Alcohol Drinkers

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