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

Study Overview
=================
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.

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

Conditions
-----------------
Alcohol Drinking, Cirrhosis, Alcohol Withdrawal

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients treated with baclofen<br>Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Alcohol consumption | Evolution of the alcohol consumption in patients under baclofen therapy | at inclusion, at 3, 6 and 12 months of follow-up | 
| 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 | 
| baclofen tolerance | Description of the side effects under baclofen therapy | at 3, 6 and 12 months of follow-up | 
| Baclofen dosage | Blood baclofen dosage under baclofen treatment, if available | at 3, 6 and 12 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
baclofen, alcohol, withdrawal