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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with baclofen | Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Camille barrault, MD | CHI Créteil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier yves LEFOLL | Saint-Brieuc | Côtes d'Armor | 22023 | France | ||
| Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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biologic sample to dose the blood baclofenemia
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 |
| Besançon |
| Franche-Comté |
| 25030 |
| France |
| CH Béziers | Béziers | Hérault | 34525 | France |
| CH Orleans | Orléans | Loiret | 45067 | France |
| GHPSO Creil-Senlis | Creil | Oise | 60109 | France |
| CH meaux | Meaux | Seine Et Marne | 77100 | France |
| CHI CRETEIL addictology | Créteil | 94000 | France |
| Hôpital saint denis | Saint-Denis | Île-de-France Region | 93205 | France |