Clinical trial NCT01738282: Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: baclofene
Alcohol dependence
Maintenance of abstinence
Lead sponsor: Ethypharm
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
timeFrame: Day 168
Secondary outcomes:
measure: 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
timeFrame: Day 168
measure: 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
timeFrame: Day 210
measure: Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence
timeFrame: Day 168
measure: 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)
timeFrame: Day 168
measure: Drinking characteristics for patients having a relapse between Day 1 and Day 210
timeFrame: Day 210
measure: Change in craving, addiction and Quality of Life scales
timeFrame: Day 210
measure: Recording of safety data
timeFrame: Day 210
Other outcomes:
Locations:
city: Angers
country: France
city: Bron
country: France
city: Clermont de l'Oise
country: France
city: Clermont Ferrand
country: France
facility: CHU
city: Clichy
country: France
facility: Hopital Beaujon
city: Dax
country: France
city: Dijon
country: France
facility: Centre hospitalier
city: Erstein
country: France
facility: Centre hospitalier
city: L'Arbresle
country: France
city: La Membrolle sur Choisille
country: France
facility: Centre hospitalier
city: La Tronche
country: France
facility: Hopital Michallon
city: Le Mans
country: France
facility: Centre hospitalier
city: Lille
country: France
facility: CHRU
city: Lille
country: France
facility: CSAPA
city: Limoges
country: France
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: Hopital Sainte Marguerite
city: Montauban
country: France
facility: Centre hospitalier
city: Morlaix
country: France
city: Nancy
country: France
facility: Hopital Villemin
city: Nantes
country: France
facility: CHU
city: Nice
country: France
facility: Centre hospitalier
city: Nimes
country: France
facility: CHRU
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Fernand Widal
city: Paris
country: France
facility: Hopital Saint Anne
city: Perpignan
country: France
facility: Centre hospitalier
city: Pont du Casse
country: France
facility: Centre hospitalier
city: Reims
country: France
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Roubaix
country: France
facility: Hopital de la Fraternité
city: Saint Egreve
country: France
city: Sevran
country: France
facility: Hopital René Muret
city: Seynod
country: France
facility: CSAPA
city: Toulon
country: France
facility: Centre hospitalier intercommunal
city: Vandoeuvre les Nancy
country: France
facility: Hopital Brabois
city: Villejuif
country: France
facility: Hopital Paul Brousse
Study officials:
affiliation: Villejuif, France
name: Michel REYNAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.