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

NCT02596763 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Baclofen

Patient receiving an off-label baclofen treatment for alcohol use disorder for less than 1 month.

Sponsors & Collaborators

  • Région Nord-Pas de Calais, France

    collaborator OTHER

  • Groupement Interrégional de Recherche Clinique et d'Innovation

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Renaud JARDRI, MD, PhD · CHRU de Lille

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-24
Primary Completion
2018-12-24
Completion
2018-12-24

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596763 on ClinicalTrials.gov