Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions
(Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of
792 patients during their first year of baclofen prescription for alcohol use disorder.
The main objective of the study is to determine the rate of patients who stop baclofen due to
an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to
determine which types of AEs and serious AEs are actually liable to baclofen, and which other
types are more likely the consequence of confounding factors, e.g., concomitant alcohol,
psychotropic medications or substance uses, and comorbidities.