Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients (ALPADIR)

July 29, 2014 updated by: Ethypharm

A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

316

Phase

  • 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
      • Angers, France
      • Bron, France
      • Clermont Ferrand, France
        • CHU
      • Clermont de l'Oise, France
      • Clichy, France
        • Hopital Beaujon
      • Dax, France
      • Dijon, France
        • Centre Hospitalier
      • Erstein, France
        • Centre Hospitalier
      • L'Arbresle, France
      • La Membrolle sur Choisille, France
        • Centre Hospitalier
      • La Tronche, France
        • Hôpital Michallon
      • Le Mans, France
        • Centre Hospitalier
      • Lille, France
        • CHRU
      • Lille, France
        • CSAPA
      • Limoges, France
      • Lyon, France
        • Hôpital de la Croix Rousse
      • Marseille, France
        • Hôpital Sainte Marguerite
      • Montauban, France
        • Centre Hospitalier
      • Morlaix, France
      • Nancy, France
        • Hopital Villemin
      • Nantes, France
        • CHU
      • Nice, France
        • Centre Hospitalier
      • Nimes, France
        • CHRU
      • Paris, France
        • Hopital Cochin
      • Paris, France
        • Hopital Bichat Claude Bernard
      • Paris, France
        • Hôpital Fernand Widal
      • Paris, France
        • Hôpital Saint Anne
      • Perpignan, France
        • Centre Hospitalier
      • Pont du Casse, France
        • Centre Hospitalier
      • Reims, France
      • Rennes, France
        • Hopital Pontchaillou
      • Roubaix, France
        • Hopital de la Fraternité
      • Saint Egreve, France
      • Sevran, France
        • Hôpital René Muret
      • Seynod, France
        • CSAPA
      • Toulon, France
        • Centre Hospitalier Intercommunal
      • Vandoeuvre les Nancy, France
        • Hôpital Brabois
      • Villejuif, France
        • Hopital Paul Brousse

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence
  • Willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal
  • Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days
  • At least one previous abstinence attempt

Exclusion Criteria:

  • Need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction
  • Need for a heavy psychosocial out of hospital care
  • History of baclofen intake, by prescription or self medication
  • Porphyria
  • Concomitant treatment with one or several drugs for the maintenance of abstinence
  • Severe renal, cardiac or pulmonary disorder
  • Epilepsy or history of epilepsy
  • Concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam
  • Severe psychiatric disease (schizophrenia and bipolar disorder)
  • Suicidal risk or history of suicide
  • Clinically significant cognitive disorders
  • Hepatic encephalopathy
  • Ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs…), excepted tobacco

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baclofen
Baclofen 20mg tablet. Titration:increasing dosage regimen to reach the target dosage of 180 mg (9 tablets)in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
Drug: Baclofen
Placebo Comparator: Placebo
Placebo tablet Titration:increasing dosage regimen to reach the target dosage of 9 tablets in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
Drug: Placebo (for baclofen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
Time Frame: Day 168
Day 168

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of the maintenance dose period (Day 168), i.e. 24 weeks
Time Frame: Day 168
Day 168
Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of 4-week post treatment follow up period (Day 210), i.e. 30 weeks
Time Frame: Day 210
Day 210
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence
Time Frame: Day 168
Day 168
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the level of drinking before withdrawal (Time Line Follow Back calendar/ World Health Organization criteria for risk of consumption)
Time Frame: Day 168
Day 168
Drinking characteristics for patients having a relapse between Day 1 and Day 210
Time Frame: Day 210
Time to relapse (Day 1 to first drinking day) Time to relapse to first high risk drinking day (>60g for a male, > 40g for a female) Percentage of drinking days from Day 1 to Day 210 Mean number of standard drinks per drinking day and classification according to World Health Organization criteria for the risk of consumption Percentage of high risk drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of high risk drinking days during the preceding 4 weeks of the withdrawal Percentage of drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of drinking days during the preceding 4 weeks of the withdrawal
Day 210
Change in craving, addiction and Quality of Life scales
Time Frame: Day 210
Clinical Global Impression (CGI), Alcohol dependence Quality of Life (AlQoL9), Obsessive Compulsive Drinking Scale (OCDS), Hospital Anxiety and Depression Scale (HAD), Visual Analogue Scale (VAS) craving scores and liver biomarkers
Day 210
Recording of safety data
Time Frame: Day 210
Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test
Day 210

Collaborators and Investigators

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

Sponsor

Ethypharm

Investigators

  • Principal Investigator: Michel REYNAUD, MD, Villejuif, France

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

December 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALP 2011007/002

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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