PMID- 27984918
OWN - NLM
STAT- MEDLINE
DCOM- 20170310
LR  - 20170310
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 16
IP  - 2
DP  - 2017 Feb
TI  - Phone-based safety monitoring of the first year of baclofen treatment for alcohol 
      use disorder: the BACLOPHONE cohort study protocol.
PG  - 125-132
LID - 10.1080/14740338.2017.1270939 [doi]
AB  - BACKGROUND: In France, baclofen is frequently used off-label for alcohol use 
      disorder (AUD). Baclofen has been associated with diverse adverse events (AEs), 
      but the causality of these AEs has never been properly assessed. METHODS/DESIGN: 
      BACLOPHONE is a prospective multicenter cohort study conducted in the 
      Hauts-de-France and Normandie French regions. BACLOPHONE consists of the 
      phone-based monitoring of 792 patients during their first year of baclofen 
      treatment for AUD. Two initial phone interviews assess the medical history, 
      current medications, and substance use as well as complete the alcohol use 
      identification test (AUDIT) and severity of alcohol dependence questionnaire 
      (SADQ). Daily alcohol use and baclofen doses are noted throughout the follow-up. 
      For every reported AE, additional phone interviews determine the seriousness of 
      the AE, the causality of baclofen using validated causality algorithms, and the 
      final outcome. The main objective of the study is to determine the rate of 
      patients who stop baclofen due to an AE during the first year of treatment. 
      DISCUSSION: BACLOPHONE will provide important safety data on baclofen as a 
      complement to the forthcoming efficacy data of randomized clinical trials.
FAU - Rolland, Benjamin
AU  - Rolland B
AD  - a Departement de Pharmacologie Medicale , INSERM U 1171, Univ Lille , Lille , 
      France.
AD  - b Service d'Addictologie, CHU Lille , Lille , France.
FAU - Auffret, Marine
AU  - Auffret M
AD  - c Centre Regional de Pharmacovigilance, CHU Lille , Lille , France.
FAU - Labreuche, Julien
AU  - Labreuche J
AD  - d Plateforme d'Aide Methodologique , Biostatistique et Datamanagement, CHU Lille 
      , Lille , France.
FAU - Lapeyre-Mestre, Maryse
AU  - Lapeyre-Mestre M
AD  - e Service de Pharmacologie Clinique, CEIP-Addictovigilance, CIC 1436, CHU de 
      ToulouseUMR-INSERM 1027 Universite Paul Sabatier - Toulouse 3 , Toulouse , 
      France.
FAU - Dib, Malek
AU  - Dib M
AD  - f Federation de Recherche Clinique, CHU Lille , Lille , France.
FAU - Kemkem, Aomar
AU  - Kemkem A
AD  - f Federation de Recherche Clinique, CHU Lille , Lille , France.
FAU - Grit, Isabelle
AU  - Grit I
AD  - f Federation de Recherche Clinique, CHU Lille , Lille , France.
FAU - Drelon, Marie
AU  - Drelon M
AD  - g Centre d'Investigation Clinique, CHU Lille , Lille , France.
FAU - Duhamel, Alain
AU  - Duhamel A
AD  - d Plateforme d'Aide Methodologique , Biostatistique et Datamanagement, CHU Lille 
      , Lille , France.
AD  - h CERIM, EA 2694, Univ Lille , Lille , France.
FAU - Cabe, Nicolas
AU  - Cabe N
AD  - i Service d'Addictologie, CHU de Caen , Caen , France.
FAU - Vabret, Francois
AU  - Vabret F
AD  - i Service d'Addictologie, CHU de Caen , Caen , France.
FAU - Guillin, Olivier
AU  - Guillin O
AD  - k Centre Hospitalier du Rouvray, CHU de Rouen , Rouen , France.
FAU - Baguet, Alexandre
AU  - Baguet A
AD  - j Service d'Addictologie, CHU de Rouen , Rouen , France.
FAU - Masquelier, Celine
AU  - Masquelier C
AD  - p Centre Hospitalier Regional Universitaire de Lille Ringgold standard 
      institution - Biostatistics CHU Lille , Lille , France.
FAU - Dervaux, Alain
AU  - Dervaux A
AD  - l Service d'Addictologie, CHU d'Amiens , Amiens , France.
FAU - Deheul, Sylvie
AU  - Deheul S
AD  - m Centre d'Evaluation et d'Information sur les Pharmacodependances, CHU Lille , 
      Lille , France.
FAU - Bordet, Regis
AU  - Bordet R
AD  - a Departement de Pharmacologie Medicale , INSERM U 1171, Univ Lille , Lille , 
      France.
AD  - c Centre Regional de Pharmacovigilance, CHU Lille , Lille , France.
AD  - m Centre d'Evaluation et d'Information sur les Pharmacodependances, CHU Lille , 
      Lille , France.
FAU - Carton, Louise
AU  - Carton L
AD  - a Departement de Pharmacologie Medicale , INSERM U 1171, Univ Lille , Lille , 
      France.
FAU - Cottencin, Olivier
AU  - Cottencin O
AD  - b Service d'Addictologie, CHU Lille , Lille , France.
AD  - n SCALab UMR CNRS 9193, Univ Lille , Lille , France.
FAU - Jardri, Renaud
AU  - Jardri R
AD  - n SCALab UMR CNRS 9193, Univ Lille , Lille , France.
AD  - o Centre Universitaire de Recherche et d'Exploration, CHU Lille , Lille , France.
FAU - Gautier, Sophie
AU  - Gautier S
AD  - a Departement de Pharmacologie Medicale , INSERM U 1171, Univ Lille , Lille , 
      France.
AD  - c Centre Regional de Pharmacovigilance, CHU Lille , Lille , France.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20161221
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (GABA-B Receptor Agonists)
RN  - H789N3FKE8 (Baclofen)
SB  - IM
MH  - Alcohol Drinking/prevention & control
MH  - Alcoholism/*drug therapy
MH  - Algorithms
MH  - Baclofen/administration & dosage/*adverse effects
MH  - Cohort Studies
MH  - Drug Monitoring/methods
MH  - Follow-Up Studies
MH  - France
MH  - GABA-B Receptor Agonists/administration & dosage/*adverse effects
MH  - Humans
MH  - Off-Label Use
MH  - Prospective Studies
MH  - Surveys and Questionnaires
MH  - *Telephone
OTO - NOTNLM
OT  - Baclofen
OT  - adverse drug reaction reporting systems
OT  - alcoholism
OT  - causality
OT  - drug-related side effects and adverse reactions
OT  - off-label use
OT  - patient safety
OT  - pharmacovigilance
OT  - telephone
EDAT- 2016/12/18 06:00
MHDA- 2017/03/11 06:00
CRDT- 2016/12/18 06:00
PHST- 2016/12/18 06:00 [pubmed]
PHST- 2017/03/11 06:00 [medline]
PHST- 2016/12/18 06:00 [entrez]
AID - 10.1080/14740338.2017.1270939 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2017 Feb;16(2):125-132. doi: 10.1080/14740338.2017.1270939. 
      Epub 2016 Dec 21.