Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study.
Oliver HendricksTonny Elmose AndersenAfshin Ashouri ChristiansenJette PrimdahlEllen Margrethe HaugeTorkell EllingsenTina Ingrid HorstedAnja Godske BachmannAnne Gitte LoftAnders Bo BojesenMikkel ØstergaardMerete Lund HetlandNiels Steen KroghKirsten Kaya RoesslerKim Hørslev PetersenPublished in: BMJ open (2019)
The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.