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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

Tracking Information
First Submitted Date July 11, 2016
First Posted Date July 18, 2016
Last Update Posted Date February 6, 2019
Actual Study Start Date January 1, 2015
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France
Official Title Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
biologic sample to dose the blood baclofenemia
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.
Condition
  • Alcohol Drinking
  • Cirrhosis
  • Alcohol Withdrawal
Intervention Not Provided
Study Groups/Cohorts patients treated with baclofen
Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2019)
218
Original Estimated Enrollment
 (submitted: July 13, 2016)
200
Actual Study Completion Date September 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02835365
Other Study ID Numbers OBADE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Camille Barrault, Centre Hospitalier Intercommunal Creteil
Study Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
Investigators
Principal Investigator: Camille barrault, MD CHI Créteil
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date February 2019