Phone-based safety monitoring of the first year of baclofen treatment for alcohol use disorder: the baclophone cohort study protocol

Benjamin Rolland; Marine Auffret; Julien Labreuche; Maryse Lapeyre-Mestre; Malek Dib; Aomar Kemkem; Isabelle Grit; Marie Drelon; Alain Duhamel; Nicolas Cabe; François Vabret; Olivier Guillin; Alexandre Baguet; Celine Masquelier; Alain Dervaux; Sylvie Deheul; Regis Bordet; Louise Carton; Olivier Cottencin; Renaud Jardri; Sophie Gautier

doi:10.1080/14740338.2017.1270939

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Phone-based safety monitoring of the first year of baclofen treatment for alcohol use disorder: the baclophone cohort study protocol

Benjamin Rolland ^{1, 2} Marine Auffret ¹ Julien Labreuche ³ Maryse Lapeyre-Mestre ^{4, 5} Malek Dib ¹ Aomar Kemkem ¹ Isabelle Grit ¹ Marie Drelon Alain Duhamel ³ Nicolas Cabe ⁶ François Vabret ⁶ Olivier Guillin ⁷ Alexandre Baguet ⁷ Celine Masquelier Alain Dervaux Sylvie Deheul Regis Bordet ² Louise Carton Olivier Cottencin ⁸ Renaud Jardri ⁸ Sophie Gautier ²

1 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]

2 TCDV - Troubles cognitifs dégénératifs et vasculaires - U 1171

3 METRICS - Evaluation des technologies de santé et des pratiques médicales - ULR 2694

4 CIC 1436 - CHU de Toulouse/Inserm/UPS - CIC - Toulouse

5 UT3 - Université Toulouse III - Paul Sabatier

6 CHU Caen

7 CHU Rouen

8 SCALab - Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193

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.

Keywords : patient safety Baclofen drug-related side effects and adverse reactions pharmacovigilance adverse drug reaction reporting systems causality telephone off-label use alcoholism Mesh:Alcoholism/drug therapy* Mesh:Algorithms Mesh:Prospective Studies Mesh:Telephone* Mesh:Off-Label Use Mesh:Surveys and Questionnaires Mesh:Alcohol Drinking/prevention & control Mesh:Baclofen/administration & dosage Mesh:Baclofen/adverse effects* Mesh:Cohort Studies Mesh:Drug Monitoring/methods Mesh:Follow-Up Studies Mesh:France Mesh:GABA-B Receptor Agonists/administration & dosage Mesh:GABA-B Receptor Agonists/adverse effects* Mesh:Humans

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Article dans une revue

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Sciences du Vivant [q-bio]

Sciences cognitives

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https://hal.univ-lille.fr/hal-02534550
Contributeur : Lilloa Université de Lille <>
Soumis le : mardi 7 avril 2020 - 10:22:51
Dernière modification le : mardi 3 novembre 2020 - 15:54:06

Phone-based safety monitoring of the first year of baclofen treatment for alcohol use disorder: the baclophone cohort study protocol

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