Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02596763 En recrutement IDF

Titre

Phone-based Safety Monitoring of the First Year of Baclofen Treatment for Alcohol Use Disorder: the BACLOPHONE Cohort Study (BACLOPHONE)

Type

Interventional

Pathologie

Consommation d'alcool
Alcoolisme

Phase

Phase 4

Promoteur

University Hospital, Lille (Voir sur ClinicalTrials)

Date de début

décembre 2015

Date de fin

janvier 2022

Dernière mise à jour

19 octobre 2024

Résumé

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.

Détail

Voir le détail Inclusions are performed by any previously-labeled baclofen-prescribing physician in the Hauts-de-France or Normandie French regions. INITIAL ASSESSMENT PHONE CALLS In the 15 days following the inclusion, participants will receive two successive phone calls. The first call will be performed by a physician investigator of the study who will: re-explain the principles of the study to patients, check the absence of non-inclusion criteria, and note the medical history, date of baclofen initiation and current dose, undergoing medications and current doses, occurrence of AEs since the initiation of baclofen, birthdate, weight, and height. The physician will also check whether specific safety elements important with regards to the baclofen treatment are noticeable in the patient: history of seizures, suicide, and other concurrent substance use. The second phone call is performed by a clinical research associate (CRA) who will check the absence of non-inclusion criteria, and collects the 30 last-days reported alcohol use according to alcohol timeline follow-back (A-TLFB) method, date of initiation and current dose of baclofen, severity alcohol dependence questionnaire (SADQ), alcohol use disorder identification test (AUDIT), and A-B neuropsychological assessment schedule (ABNAS) which scores the current level of sedation in patients with psychotropic drugs. FOLLOW-UP PHONE CALLS During the subsequent one-year follow-up, two types of phone interviews are performed: 1) Monthly Standardized Interviews (MSI). MSIs consist in collecting the previous-month daily use of alcohol using the A-TLFB, the daily dose of baclofen across the previous month, the current ABNAS sedation score, any change in any associated medication, any change in any substance use, and any AE reported by the patient. No predefined list of AEs is used, as the investigator only asks the patient if he/she has noticed or experienced any unexpected symptoms of health issues since the last call. The daily dose distribution of baclofen, i.e., hours and doses of baclofen intakes, are also systematically investigated in the patient. The average subjective level of craving for alcohol is self-scored by the patient using a 0-10 verbal rating scale (i.e., 0 for no craving at all, to 10 for the most severe possible craving). The daily hours of maximum craving is also noted. 2) Semi-standardized Pharmacovigilance Interviews (SPI) which are unscheduled, and are performed in the case of an AE reported by the patient to the CRA, or in the case of a direct phone call to the pharmacovigilance center by the patient or their baclofen prescriber, with the aim to report an AE. Data collected are: current baclofen dose and recent changes in baclofen dosing, recent and current drinking patterns, associated medications, type of AE, 'serious' feature of the AE according to the definition of the Food and Drugs Administration, onset date and occurrence conditions. Patients can be secondarily re-contacted to assess the final outcome of the AE, and to determine the causality score of baclofen regarding the AE, using both the French causality method and the Naranjo's algorithm if applicable. DELAYED PHONE CALL IN THE CASE OF BACLOFEN CESSATION If baclofen is stopped for any reason during the year following the initiation, a last phone interview will be conducted by the CRA 3 months after baclofen cessation. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Camille BARRAULT	En recrutement IDF	29/03/2024 01:27:49	Contacter
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centres de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA) Le Cèdre Bleu - 59280 - Armentières - France	Marie-Christine BLANQUARD, MD	En recrutement		Contact (sur clinicalTrials)
Etablissement Public de Santé Mentale (EPSM) - 59000 - Lille - France	Véronique VOSGIEN, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 59100 - Roubaix - France	Laurent URSO, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 59300 - Dunkerque - France	Cécile RICHEZ, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 62000 - Arras - France	Dominique LEJEUNE, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 62130 - Saint Pol sur Ternoise - France	Dominique LEJEUNE, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 80100 - Abbeville - France	Maroussia WILQUIN, MD	En recrutement		Contact (sur clinicalTrials)
University Hospital of Caen - Caen - France	François VABRET, MD, PhD	Recrutement non commencé		Contact (sur clinicalTrials)
University Hospital of Rouen - Rouen - France	Alexandre BAGUET, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hospital Center - 59190 - Hazebrouck - France	Lucie MOLMY, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 59200 - Tourcoing - France	Laure SPINOSI, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 59300 - Valenciennes - France	Alexandre BONORD, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 60600 - Clermont - France	Sophie VELASTEGUI, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 62200 - Boulogne - France	Frédéric TEISSIERE, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 62220 - Carvin - France	Hugo FAVRE, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 62300 - Lens - France	Christelle DUBOCAGE, MD	En recrutement		Contact (sur clinicalTrials)
Hospital Center - 80400 - Ham - France	Michel SOCHALA, MD	En recrutement		Contact (sur clinicalTrials)
Service d'Aide aux Toxicomanes (SATO-Picardie) - 60000 - Beauvais - France	Jean-Jacques PIK, MD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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.

Critère de non inclusion

- 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.

NCT02596763 - Phone-based Safety Monitoring of the First Year of Baclofen Treatment for Alcohol Use Disorder: the BACLOPHONE Cohort Study (BACLOPHONE)

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