Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)

• Carlos Suso-Ribera,
• Azucena García-Palacios,
• Juan P Sanabria-Mazo,
• Ariadna Colomer-Carbonell,
• Francesco D'Amico,
• Michael Maes,
• Xavier Borràs,
• Albert Feliu-Soler,
• Juan V Luciano,
• Jordi Muchart,
• Josep Munuera,
• Halbert Hernández-Negrín,
• Jarred W Younger,
• Antoni Rozadilla-Sacanell

Affiliations

Carlos Suso-Ribera

Universitat Jaume I, Castelló de la Plana, Spain

Azucena García-Palacios

Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain

Juan P Sanabria-Mazo

Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain

Ariadna Colomer-Carbonell

Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain

Francesco D'Amico

Personal Social Services Research Unit, London School of Economics and Political Science, London, UK

Michael Maes

Department of Psychiatry, Chulalongkorn University, Bangkok, Thailand

Xavier Borràs

Department of Basics, Developmental and Educational Psychology, Autonomous University of Barcelona, Cerdanyola del Vallès, Spain

Albert Feliu-Soler

Department of Clinical and Health Psychology, Autonomous University of Barcelona, Cerdanyola del Vallès, Spain

Juan V Luciano

Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain

Jordi Muchart

Diagnostic Imaging Department, Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain

Josep Munuera

Diagnostic Imaging Department, Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain

Halbert Hernández-Negrín

Department of Basics, Developmental and Educational Psychology, Autonomous University of Barcelona, Cerdanyola del Vallès, Spain

Jarred W Younger

University of Alabama at Birmingham, Birmingham, Alabama, USA

Antoni Rozadilla-Sacanell

Department of Rheumatology, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain