Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France (OBADE)

Centre Hospitalier Intercommunal Creteil

Status: Completed

Conditions: Alcohol Withdrawal; Cirrhosis; Alcohol Drinking

Study type: Observational

Funder types: Other

Identifiers

NCT02835365

OBADE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

218 participants in 1 patient group

patients treated with baclofen

Description:

Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled