Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France (OBADE)
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ClinicalTrials.gov Identifier: NCT02835365 |
Recruitment Status :
Completed
First Posted : July 18, 2016
Last Update Posted : February 6, 2019
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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.
Condition or disease |
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Alcohol Drinking Cirrhosis Alcohol Withdrawal |
Study Type : | Observational |
Actual Enrollment : | 218 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments |
Actual Study Start Date : | January 1, 2015 |
Actual Primary Completion Date : | August 2018 |
Actual Study Completion Date : | September 2018 |

Group/Cohort |
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patients treated with baclofen
Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled
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- Target population [ Time Frame: at inclusion ]Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.
- baclofen posology [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at 3, 6 and 12 months of follow-up ]Description of the side effects under baclofen therapy
- Baclofen dosage [ Time Frame: at 3, 6 and 12 months of follow-up ]Blood baclofen dosage under baclofen treatment, if available
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835365
France | |
Centre hospitalier yves LEFOLL | |
Saint Brieux, Côtes d'Armor, France, 22023 | |
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz | |
Besançon, Franche-Comté, France, 25030 | |
CH Béziers | |
Béziers, Hérault, France, 34525 | |
Hôpital saint denis | |
Saint denis, Ile De France, France, 93205 | |
CH Orleans | |
Orleans, Loiret, France, 45067 | |
GHPSO Creil-Senlis | |
Creil, Oise, France, 60109 | |
CH meaux | |
Meaux, Seine Et Marne, France, 77100 | |
CHI CRETEIL addictology | |
Creteil, France, 94000 |
Principal Investigator: | Camille barrault, MD | CHI Créteil |
Responsible Party: | Camille Barrault, Dr, Centre Hospitalier Intercommunal Creteil |
ClinicalTrials.gov Identifier: | NCT02835365 |
Other Study ID Numbers: |
OBADE |
First Posted: | July 18, 2016 Key Record Dates |
Last Update Posted: | February 6, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
baclofen alcohol withdrawal |
Alcoholism Alcohol Drinking Alcohol-Related Disorders Substance-Related Disorders |
Chemically-Induced Disorders Mental Disorders Drinking Behavior |