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

NCT02596763 | Terminated Phase 4 DMC

• 3 other identifiers: 2014_452015-002977-40PHRCI_2015
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 19

Brief 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

Alcohol Use Disorder

Keywords

Off-label prescription; Alcoholism; Pharmacovigilance; Pharmacoepidemiology; Baclofen

Outcome Measures

Primary Outcomes (1)

• Discontinuation of baclofen because of an AE

  The link between AE and the discontinuation of baclofen will be defined by the results of the analysis of the pharmacovigilance team. the one-year probability (with it 95% confidence interval) of baclofen discontinuation due to the occurrence of an AE will be estimated using the Kaplan-Meier method. Drop-outs, death, or baclofen discontinuation for other reasons than an AE will be treated as censoring events. A sensitivity analysis treating death or baclofen discontinuation for other reasons than an AE as competing risk will be performed using the approach of Kalbfleisch and Prentice.

  First year of treatment

Secondary Outcomes (4)

• Frequency of the different types of AEs and SAEs occuring on baclofen

  First year of treatment

• Relationship between the occurrence of the first sedative AE and alcohol and baclofen dosing

  First year of treatment

• Causality of baclofen in the occurrence each AE

  First year of treatment

• Proportion of patients whose prescription meets the official prescription requirements of the Temporary Recommendation for Use (TRU)

  First year of treatment

Study Arms (1)

Baclofen

OTHER

Patient with current alcohol use disorder included by any baclofen prescriber located in the French region of Nord - Pas-de-Calais - Picardie.

Drug: Baclofen

Interventions

Baclofen DRUG

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

Also known as: Agonist of GABA B receptors

Baclofen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Région Nord-Pas de Calais, France: collaborator
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator

Study Sites (19)

Hospital Center

Abbeville, 80100, France

Location

Centres de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA) Le Cèdre Bleu

Armentières, 59280, France

Location

Hospital Center

Arras, 62000, France

Location

Service d'Aide aux Toxicomanes (SATO-Picardie)

Beauvais, 60000, France

Location

Hospital Center

Boulogne, 62200, France

Location

University Hospital of Caen

Caen, France

Location

Hospital Center

Carvin, 62220, France

Location

Hospital Center

Clermont, 60600, France

Location

Hospital Center

Dunkirk, 59300, France

Location

Hospital Center

Ham, 80400, France

Location

Hospital Center

Hazebrouck, 59190, France

Location

Hospital Center

Lens, 62300, France

Location

Etablissement Public de Santé Mentale (EPSM)

Lille, 59000, France

Location

Hospital Center

Roubaix, 59100, France

Location

University Hospital of Rouen

Rouen, France

Location

Hospital Center

Saint-Amand-les-Eaux, 59230, France

Location

Hospital Center

Saint-Pol-sur-Ternoise, 62130, France

Location

Hospital Center

Tourcoing, 59200, France

Location

Hospital Center

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Renaud JARDRI, MD, PhD

  CHRU de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 4, 2015
• Study Start: December 24, 2015
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)