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NCT Number: NCT02835365

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

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.

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Key information

Conditions

Alcohol Drinking Alcohol Withdrawal Behavior Cirrhosis Drinking Behavior Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier yves LEFOLL, Saint-Brieuc, Côtes d'Armor, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments

Acronym: OBADE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2016
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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