Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France

NCT02835365 | Completed

• 1 other identifier: OBADE
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 8

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.

Conditions

Alcohol Drinking; Cirrhosis; Alcohol Withdrawal

Keywords

baclofen; alcohol; withdrawal

Outcome Measures

Primary Outcomes (1)

• Target population

  Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.

  at inclusion

Secondary Outcomes (5)

• baclofen posology

  at inclusion, at 3, 6 and 12 months of follow-up

• Alcohol consumption

  at inclusion, at 3, 6 and 12 months of follow-up

• Biological markers of alcohol consumption

  at inclusion, at 3, 6 and 12 months of follow-up

• baclofen tolerance

  at 3, 6 and 12 months of follow-up

• Baclofen dosage

  at 3, 6 and 12 months of follow-up

Study Arms (1)

patients treated with baclofen

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients older than 18 years old
• patient treated with baclofen therapy after 2012 for alcoholo-dependance

You may not qualify if:

• Baclofen therapy before 2012
• patient who refuse to participate

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (8)

Centre hospitalier yves LEFOLL

Saint-Brieuc, Côtes d'Armor, 22023, France

Location

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

Besançon, Franche-Comté, 25030, France

Location

CH Béziers

Béziers, Hérault, 34525, France

Location

CH Orleans

Orléans, Loiret, 45067, France

Location

GHPSO Creil-Senlis

Creil, Oise, 60109, France

Location

CH meaux

Meaux, Seine Et Marne, 77100, France

Location

CHI CRETEIL addictology

Créteil, 94000, France

Location

Hôpital saint denis

Saint-Denis, Île-de-France Region, 93205, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

biologic sample to dose the blood baclofenemia

MeSH Terms

Conditions

Alcohol Drinking; Fibrosis

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Camille barrault, MD

  CHI Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 18, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)