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

Completed

• Conditions: Alcohol Drinking; Alcohol Withdrawal; Cirrhosis

• Registration Number: NCT02835365
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target population	at inclusion	Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.

Secondary Outcome Measures

Name	Time	Method
baclofen posology	at inclusion, at 3, 6 and 12 months of follow-up	used baclofen posology will be recorded to determine the posology scheme to treat patients with or without cirrhosis
baclofen tolerance	at 3, 6 and 12 months of follow-up	Description of the side effects under baclofen therapy
Baclofen dosage	at 3, 6 and 12 months of follow-up	Blood baclofen dosage under baclofen treatment, if available
Biological markers of alcohol consumption	at inclusion, at 3, 6 and 12 months of follow-up	Evolution of the biological markers of alcohol consumption in patients under baclofen therapy
Alcohol consumption	at inclusion, at 3, 6 and 12 months of follow-up	Evolution of the alcohol consumption in patients under baclofen therapy

Trial Locations

Locations (8)

Centre hospitalier yves LEFOLL; 🇫🇷 Saint-Brieuc, Côtes d'Armor, France

GHPSO Creil-Senlis; 🇫🇷 Creil, Oise, France

CH meaux; 🇫🇷 Meaux, Seine Et Marne, France

CHI CRETEIL addictology; 🇫🇷 Creteil, France

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz; 🇫🇷 Besançon, Franche-Comté, France

CH Béziers; 🇫🇷 Béziers, Hérault, France

Hôpital saint denis; 🇫🇷 Saint denis, Ile De France, France

CH Orleans; 🇫🇷 Orleans, Loiret, France