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.

KEYWORDS:

• Baclofen
• off-label use
• alcoholism
• patient safety
• drug-related side effects and adverse reactions
• pharmacovigilance
• adverse drug reaction reporting systems
• causality
• telephone

Acknowledgments

The authors thank Samuel Blaise (Association Olivier Ameisen), Sylvie Imbert (Association Baclofene; http://www.baclofene.org), and Yves Brasey (Association AUBES; http://www.baclofene.fr/portal.php) for their organizational support. The authors also thank Florence Nosal, Benjamin Fligans, and Grégory Mercier for their technical help. Trial Registration: NCT02596763; EudraCT 2015-002977-40 Version 2.0 (June 2016)

Declaration of interest

B Rolland was the principal investigator of a study funded by Ethypharm. He received consulting, lecture fees, and travel support from Lundbeck and Ethypham. O Cottencin was investigator in a study funded by Ethypharm. He has received sponsorship to attend scientific meetings from Lundbeck, BMS, Otsuka, Janssen Cilag, Reckitt Benckiser, Pfizer, and Bouchara Recordati. R Bordet has received lecture fees from Lundbeck. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Additional information

Funding

BACLOPHONE is funded by the Conseil Régional Nord – Pas-de-Calais (#DRESS/SAF/Numéro Astre: 2014_11213) and the GIRCI Nord-Ouest (#API15-25).