Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
ALPADIR
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
1 other identifier
interventional
316
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 30, 2014
July 1, 2014
1.6 years
November 26, 2012
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
Day 168
Secondary Outcomes (7)
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
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
Day 210
Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence
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)
Day 168
Drinking characteristics for patients having a relapse between Day 1 and Day 210
Day 210
- +2 more secondary outcomes
Study Arms (2)
Baclofen
EXPERIMENTALBaclofen 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
PLACEBO COMPARATORPlacebo 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethypharmlead
Study Sites (38)
Unknown Facility
Angers, France
Unknown Facility
Bron, France
Unknown Facility
Clermont de l'Oise, France
CHU
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Unknown Facility
Dax, France
Centre hospitalier
Dijon, France
Centre hospitalier
Erstein, France
Centre hospitalier
La Membrolle-sur-Choisille, France
Hopital Michallon
La Tronche, France
Unknown Facility
LArbresle, France
Centre hospitalier
Le Mans, France
CHRU
Lille, France
CSAPA
Lille, France
Unknown Facility
Limoges, France
Hopital de la Croix Rousse
Lyon, France
Hopital Sainte Marguerite
Marseille, France
Centre hospitalier
Montauban, France
Unknown Facility
Morlaix, France
Hopital Villemin
Nancy, France
CHU
Nantes, France
Centre hospitalier
Nice, France
CHRU
Nîmes, France
Hopital Bichat Claude Bernard
Paris, France
Hopital Cochin
Paris, France
Hopital Fernand Widal
Paris, France
Hopital Saint Anne
Paris, France
Centre hospitalier
Perpignan, France
Centre hospitalier
Pont-du-Casse, France
Unknown Facility
Reims, France
Hopital Pontchaillou
Rennes, France
Hopital de la Fraternité
Roubaix, France
Unknown Facility
Saint-Égrève, France
Hopital René Muret
Sevran, France
CSAPA
Seynod, France
Centre hospitalier intercommunal
Toulon, France
Hopital Brabois
Vandœuvre-lès-Nancy, France
Hopital Paul Brousse
Villejuif, France
Related Publications (1)
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.
PMID: 33012365DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel REYNAUD, MD
Villejuif, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2012
First Posted
November 30, 2012
Study Start
December 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 30, 2014
Record last verified: 2014-07