title: Phone-based safety monitoring of the first year of baclofen treatment for alcohol use disorder: the BACLOPHONE cohort study protocol.
abstract: BACKGROUND
  In France, baclofen is frequently used off-label for alcohol use disorder (AUD). Baclofen has been associated with diverse adverse events (AEs), but the causality of these AEs has never been properly assessed.
  
  
  METHODS
  BACLOPHONE is a prospective multicenter cohort study conducted in the Hauts-de-France and Normandie French regions. BACLOPHONE consists of the phone-based monitoring of 792 patients during their first year of baclofen treatment for AUD. Two initial phone interviews assess the medical history, current medications, and substance use as well as complete the alcohol use identification test (AUDIT) and severity of alcohol dependence questionnaire (SADQ). Daily alcohol use and baclofen doses are noted throughout the follow-up. For every reported AE, additional phone interviews determine the seriousness of the AE, the causality of baclofen using validated causality algorithms, and the final outcome. The main objective of the study is to determine the rate of patients who stop baclofen due to an AE during the first year of treatment.
  
  
  CONCLUSIONS
  BACLOPHONE will provide important safety data on baclofen as a complement to the forthcoming efficacy data of randomized clinical trials.
authors.affiliation: a Département de Pharmacologie Médicale , INSERM U 1171, Univ Lille , Lille , France.|b Service d'Addictologie, CHU Lille , Lille , France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rolland
authors.affiliation: c Centre Régional de Pharmacovigilance, CHU Lille , Lille , France.
authors.forename: Marine
authors.initials: M
authors.lastname: Auffret
authors.affiliation: d Plateforme d'Aide Méthodologique , Biostatistique et Datamanagement, CHU Lille , Lille , France.
authors.forename: Julien
authors.initials: J
authors.lastname: Labreuche
authors.affiliation: e Service de Pharmacologie Clinique, CEIP-Addictovigilance, CIC 1436, CHU de ToulouseUMR-INSERM 1027 Universite Paul Sabatier - Toulouse 3 , Toulouse , France.
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.affiliation: f Fédération de Recherche Clinique, CHU Lille , Lille , France.
authors.forename: Malek
authors.initials: M
authors.lastname: Dib
authors.affiliation: f Fédération de Recherche Clinique, CHU Lille , Lille , France.
authors.forename: Aomar
authors.initials: A
authors.lastname: Kemkem
authors.affiliation: f Fédération de Recherche Clinique, CHU Lille , Lille , France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Grit
authors.affiliation: g Centre d'Investigation Clinique, CHU Lille , Lille , France.
authors.forename: Marie
authors.initials: M
authors.lastname: Drelon
authors.affiliation: d Plateforme d'Aide Méthodologique , Biostatistique et Datamanagement, CHU Lille , Lille , France.|h CERIM, EA 2694, Univ Lille , Lille , France.
authors.forename: Alain
authors.initials: A
authors.lastname: Duhamel
authors.affiliation: i Service d'Addictologie, CHU de Caen , Caen , France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Cabe
authors.affiliation: i Service d'Addictologie, CHU de Caen , Caen , France.
authors.forename: François
authors.initials: F
authors.lastname: Vabret
authors.affiliation: k Centre Hospitalier du Rouvray, CHU de Rouen , Rouen , France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Guillin
authors.affiliation: j Service d'Addictologie, CHU de Rouen , Rouen , France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Baguet
authors.affiliation: p Centre Hospitalier Regional Universitaire de Lille Ringgold standard institution - Biostatistics CHU Lille , Lille , France.
authors.forename: Céline
authors.initials: C
authors.lastname: Masquelier
authors.affiliation: l Service d'Addictologie, CHU d'Amiens , Amiens , France.
authors.forename: Alain
authors.initials: A
authors.lastname: Dervaux
authors.affiliation: m Centre d'Evaluation et d'Information sur les Pharmacodépendances, CHU Lille , Lille , France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Deheul
authors.affiliation: a Département de Pharmacologie Médicale , INSERM U 1171, Univ Lille , Lille , France.|c Centre Régional de Pharmacovigilance, CHU Lille , Lille , France.|m Centre d'Evaluation et d'Information sur les Pharmacodépendances, CHU Lille , Lille , France.
authors.forename: Régis
authors.initials: R
authors.lastname: Bordet
authors.affiliation: a Département de Pharmacologie Médicale , INSERM U 1171, Univ Lille , Lille , France.
authors.forename: Louise
authors.initials: L
authors.lastname: Carton
authors.affiliation: b Service d'Addictologie, CHU Lille , Lille , France.|n SCALab UMR CNRS 9193, Univ Lille , Lille , France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Cottencin
authors.affiliation: n SCALab UMR CNRS 9193, Univ Lille , Lille , France.|o Centre Universitaire de Recherche et d'Exploration, CHU Lille , Lille , France.
authors.forename: Renaud
authors.initials: R
authors.lastname: Jardri
authors.affiliation: a Département de Pharmacologie Médicale , INSERM U 1171, Univ Lille , Lille , France.|c Centre Régional de Pharmacovigilance, CHU Lille , Lille , France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
mesh_terms: D000428:Alcohol Drinking / Q000517:prevention & control; D000437:Alcoholism / Q000188:drug therapy*; D000465:Algorithms; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects*; D015331:Cohort Studies; D016903:Drug Monitoring / Q000379:methods; D005500:Follow-Up Studies; D005602:France; D058786:GABA-B Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D056687:Off-Label Use; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D013689:Telephone
chemical_list: D058786:GABA-B Receptor Agonists; D001418:Baclofen
keywords: Baclofen; adverse drug reaction reporting systems; alcoholism; causality; drug-related side effects and adverse reactions; off-label use; patient safety; pharmacovigilance; telephone