OBADE: Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients treated with baclofen Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Alcohol consumption [at inclusion, at 3, 6 and 12 months of follow-up]
Evolution of the alcohol consumption in patients under baclofen therapy
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre hospitalier yves LEFOLL | Saint Brieux | Côtes d'Armor | France | 22023 |
| 2 | Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz | Besançon | Franche-Comté | France | 25030 |
| 3 | CH Béziers | Béziers | Hérault | France | 34525 |
| 4 | Hôpital saint denis | Saint denis | Ile De France | France | 93205 |
| 5 | CH Orleans | Orleans | Loiret | France | 45067 |
| 6 | GHPSO Creil-Senlis | Creil | Oise | France | 60109 |
| 7 | CH meaux | Meaux | Seine Et Marne | France | 77100 |
| 8 | CHI CRETEIL addictology | Creteil | France | 94000 |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal Creteil
- Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
Investigators
- Principal Investigator: Camille barrault, MD, CHI Créteil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBADE