TerminatedPhase 4

Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder

Stopped: DEFAULT OF INCLUSION

France239 participantsStarted 2015-12-24

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 or more and under 80 years * Receiving an off-label baclofen treatment for alcohol use disorder for less than 15 days * Mentally and physically able to participate in telephone interviews * Reachable by phone * Living in the Hauts-de-France or Normandie French regions * Beneficiary of a health insurance plan * Informed and signed consent before the beginning of the study. Exclusion Criteria: * Baclofen prescriber not registered as investigator or not previously labeled for receiving consent, or not located in the regions of Hauts-de-France or Normandie * Patient with ICD-10 criteria for other substance dependence (except tobacco) in the past three months. * Patient not reachable by phone or unable to correctly understand the French language * Pregnancy or breastfeeding.

What they're measuring

Discontinuation of baclofen because of an AE

Timeframe: First year of treatment

Trial details

NCT IDNCT02596763

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-24