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).

Ariadna Colomer-CarbonellJuan P Sanabria-MazoHalbert Hernández-NegrínXavier BorràsCarlos Suso-RiberaAzucena García-PalaciosJordi MuchartJosep MunueraFrancesco D'AmicoMichael MaesJarred W YoungerAlbert Feliu-SolerAntoni Rozadilla-SacanellJuan V Luciano

Published in: BMJ open (2022)

NCT04739995.

Keyphrases

phase iii
placebo controlled
open label
double blind
clinical trial
phase ii
low dose
study protocol
phase ii study
high dose
radiation therapy