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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Baclofen
Placebo (for baclofen)
Sponsored by
Ethypharm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring baclofene, Alcohol dependence, Maintenance of abstinence

Eligibility Criteria

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

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

Sites / Locations

  • CHU
  • Hopital Beaujon
  • Centre hospitalier
  • Centre hospitalier
  • Centre hospitalier
  • Hopital Michallon
  • Centre hospitalier
  • CHRU
  • CSAPA
  • Hopital de la Croix Rousse
  • Hopital Sainte Marguerite
  • Centre hospitalier
  • Hopital Villemin
  • CHU
  • Centre hospitalier
  • CHRU
  • Hopital Bichat Claude Bernard
  • Hopital Cochin
  • Hopital Fernand Widal
  • Hopital Saint Anne
  • Centre hospitalier
  • Centre hospitalier
  • Hopital Pontchaillou
  • Hopital de la Fraternité
  • Hopital René Muret
  • CSAPA
  • Centre hospitalier intercommunal
  • Hopital Brabois
  • Hopital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baclofen

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence
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)
Drinking characteristics for patients having a relapse between Day 1 and 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
Change in craving, addiction and Quality of Life scales
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
Recording of safety data
Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test

Full Information

First Posted
November 26, 2012
Last Updated
July 29, 2014
Sponsor
Ethypharm
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1. Study Identification

Unique Protocol Identification Number
NCT01738282
Brief Title
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
Acronym
ALPADIR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethypharm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
baclofene, Alcohol dependence, Maintenance of abstinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baclofen
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Type
Drug
Intervention Name(s)
Placebo (for baclofen)
Primary Outcome Measure Information:
Title
Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
Time Frame
Day 168
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence
Time Frame
Day 168
Title
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
Title
Drinking characteristics for patients having a relapse between Day 1 and Day 210
Description
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
Time Frame
Day 210
Title
Change in craving, addiction and Quality of Life scales
Description
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
Time Frame
Day 210
Title
Recording of safety data
Description
Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test
Time Frame
Day 210

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel REYNAUD, MD
Organizational Affiliation
Villejuif, France
Official's Role
Principal Investigator
Facility Information:
City
Angers
Country
France
City
Bron
Country
France
City
Clermont de l'Oise
Country
France
Facility Name
CHU
City
Clermont Ferrand
Country
France
Facility Name
Hopital Beaujon
City
Clichy
Country
France
City
Dax
Country
France
Facility Name
Centre hospitalier
City
Dijon
Country
France
Facility Name
Centre hospitalier
City
Erstein
Country
France
City
L'Arbresle
Country
France
Facility Name
Centre hospitalier
City
La Membrolle sur Choisille
Country
France
Facility Name
Hopital Michallon
City
La Tronche
Country
France
Facility Name
Centre hospitalier
City
Le Mans
Country
France
Facility Name
CHRU
City
Lille
Country
France
Facility Name
CSAPA
City
Lille
Country
France
City
Limoges
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hopital Sainte Marguerite
City
Marseille
Country
France
Facility Name
Centre hospitalier
City
Montauban
Country
France
City
Morlaix
Country
France
Facility Name
Hopital Villemin
City
Nancy
Country
France
Facility Name
CHU
City
Nantes
Country
France
Facility Name
Centre hospitalier
City
Nice
Country
France
Facility Name
CHRU
City
Nimes
Country
France
Facility Name
Hopital Bichat Claude Bernard
City
Paris
Country
France
Facility Name
Hopital Cochin
City
Paris
Country
France
Facility Name
Hopital Fernand Widal
City
Paris
Country
France
Facility Name
Hopital Saint Anne
City
Paris
Country
France
Facility Name
Centre hospitalier
City
Perpignan
Country
France
Facility Name
Centre hospitalier
City
Pont du Casse
Country
France
City
Reims
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes
Country
France
Facility Name
Hopital de la Fraternité
City
Roubaix
Country
France
City
Saint Egreve
Country
France
Facility Name
Hopital René Muret
City
Sevran
Country
France
Facility Name
CSAPA
City
Seynod
Country
France
Facility Name
Centre hospitalier intercommunal
City
Toulon
Country
France
Facility Name
Hopital Brabois
City
Vandoeuvre les Nancy
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
Country
France

12. IPD Sharing Statement

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

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