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/DESIGN:

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.

DISCUSSION:

BACLOPHONE will provide important safety data on baclofen as a complement to the forthcoming efficacy data of randomized clinical trials.

• Authors: 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, Céline Masquelier, Alain Dervaux, Sylvie Deheul, Régis Bordet, Louise Carton, Olivier Cottencin, Renaud Jardri, Sophie Gautier
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 16 Issue 2 Pg. 125-132 (Feb 2017) ISSN: 1744-764X [Electronic] England
• PMID: 27984918 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• GABA-B Receptor Agonists
• Baclofen

Topics

• Alcohol Drinking (prevention & control)
• Alcoholism (drug therapy)
• Algorithms
• Baclofen (administration & dosage, adverse effects)
• Cohort Studies
• Drug Monitoring (methods)
• Follow-Up Studies
• France
• GABA-B Receptor Agonists (administration & dosage, adverse effects)
• Humans
• Off-Label Use
• Prospective Studies
• Surveys and Questionnaires
• Telephone