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

Cirrhosis Clinical Trial

— OBADE  

Official title:

Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835365
• Other study ID #: OBADE
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: September 2018

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Withdrawal
• Alcoholism
• Cirrhosis

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz	Besançon	Franche-Comté
France	CH Béziers	Béziers	Hérault
France	GHPSO Creil-Senlis	Creil	Oise
France	CHI CRETEIL addictology	Creteil
France	CH meaux	Meaux	Seine Et Marne
France	CH Orleans	Orleans	Loiret
France	Hôpital saint denis	Saint denis	Ile De France
France	Centre hospitalier yves LEFOLL	Saint-Brieuc	Côtes d'Armor

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target population	Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.	at inclusion
Secondary	baclofen posology	used baclofen posology will be recorded to determine the posology scheme to treat patients with or without cirrhosis	at inclusion, at 3, 6 and 12 months of follow-up
Secondary	Alcohol consumption	Evolution of the alcohol consumption in patients under baclofen therapy	at inclusion, at 3, 6 and 12 months of follow-up
Secondary	Biological markers of alcohol consumption	Evolution of the biological markers of alcohol consumption in patients under baclofen therapy	at inclusion, at 3, 6 and 12 months of follow-up
Secondary	baclofen tolerance	Description of the side effects under baclofen therapy	at 3, 6 and 12 months of follow-up
Secondary	Baclofen dosage	Blood baclofen dosage under baclofen treatment, if available	at 3, 6 and 12 months of follow-up