Clinical trial NCT02835365: Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France
Official title: Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Drinking
Cirrhosis
Alcohol Withdrawal
Keywords: baclofen
alcohol
withdrawal
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients older than 18 years old and who received a baclofen therapy for alcohol-dependance after 2012 in a participating site is eligible. The referral physician must inform the patient. Only patients who give their oralm accceptance will be included.

Brief summary: Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.

The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.

Detailed description: Numerous centers of the French research group of the national association of the hepatologists and gastroenterologists from general hospitals (ANGH) will be part of this study. Patients treated with baclofen for alcohol -dependence will be enroll prospectively from 2014 and retrospectively if they were treated between 2012 and 2014. The reported alcohol consumption, biological markers of excessive alcohol, initial and usual baclofen dosage, blood balofen dosage as well as clinical data will be collected.

Eligibility criteria: Inclusion Criteria:

* patients older than 18 years old
* patient treated with baclofen therapy after 2012 for alcoholo-dependance

Exclusion Criteria:

* Baclofen therapy before 2012
* patient who refuse to participate

Primary outcomes:
measure: Target population
timeFrame: at inclusion
Secondary outcomes:
measure: baclofen posology
timeFrame: at inclusion, at 3, 6 and 12 months of follow-up
measure: Alcohol consumption
timeFrame: at inclusion, at 3, 6 and 12 months of follow-up
measure: Biological markers of alcohol consumption
timeFrame: at inclusion, at 3, 6 and 12 months of follow-up
measure: baclofen tolerance
timeFrame: at 3, 6 and 12 months of follow-up
measure: Baclofen dosage
timeFrame: at 3, 6 and 12 months of follow-up
Other outcomes:
Locations:
city: Saint-Brieuc
country: France
facility: Centre hospitalier yves LEFOLL
state: Côtes d'Armor
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
state: Franche-Comté
city: Béziers
country: France
facility: CH Béziers
state: Hérault
city: Saint denis
country: France
facility: Hôpital saint denis
state: Ile De France
city: Orleans
country: France
facility: CH Orleans
state: Loiret
city: Creil
country: France
facility: GHPSO Creil-Senlis
state: Oise
city: Meaux
country: France
facility: CH meaux
state: Seine Et Marne
city: Creteil
country: France
facility: CHI CRETEIL addictology
Study officials:
affiliation: CHI Créteil
name: Camille barrault, MD
role: PRINCIPAL_INVESTIGATOR
References: