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Baclofen for the Treatment of Alcohol Drinkers (BACLOVILLE)

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ClinicalTrials.gov Identifier: NCT01604330
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
Société de Formation Thérapeutique du Généraliste
Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 21, 2012
First Posted Date  ICMJE May 23, 2012
Last Update Posted Date October 3, 2017
Actual Study Start Date  ICMJE May 29, 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
  • 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.
  • 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.
  • 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.
  • 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".
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen for the Treatment of Alcohol Drinkers
Official Title  ICMJE Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Baclofen
  • 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.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
323
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2012)
320
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604330
Other Study ID Numbers  ICMJE P110112
2011-005787-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Société de Formation Thérapeutique du Généraliste
  • Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist
Investigators  ICMJE
Principal Investigator: Philippe Jaury, MD, PhD University of Paris 5 - Rene Descartes
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP