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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
Sponsor:
Collaborator:
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
Information provided by (Responsible Party):
Camille Barrault, Centre Hospitalier Intercommunal Creteil

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
Alcohol Drinking Cirrhosis Alcohol Withdrawal

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Group/Cohort
patients treated with baclofen
Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. baclofen tolerance [ Time Frame: at 3, 6 and 12 months of follow-up ]
    Description of the side effects under baclofen therapy

  5. 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
biologic sample to dose the blood baclofenemia


Information from the National Library of Medicine

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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
Study Population
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.
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
Investigators
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Principal Investigator: Camille barrault, MD CHI Créteil

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Responsible Party: Camille Barrault, Dr, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02835365     History of Changes
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

Keywords provided by Camille Barrault, Centre Hospitalier Intercommunal Creteil:
baclofen
alcohol
withdrawal

Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs