Cannabis-opioid interaction in the treatment of fibromyalgia pain: an open-label, proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodone combination—the SPIRAL study

Trials

Study Protocol

Erik Olofsen¹  Cornelis Jan van Dam²  Monique van Velzen²  Marieke Niesters²  Albert Dahan³  Cornelis Kramers⁴  Arnt Schellekens⁵ 

[1] Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands;Tackling and Preventing The Opioid Epidemic (TAPTOE). consortium, Utrecht, the Netherlands;Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands;Tackling and Preventing The Opioid Epidemic (TAPTOE). consortium, Utrecht, the Netherlands;Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands;PainLess Foundation, Leiden, the Netherlands;Tackling and Preventing The Opioid Epidemic (TAPTOE). consortium, Utrecht, the Netherlands;Department of Clinical Pharmacy, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands;Department of Pharmacology‑Toxicology and Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands;Tackling and Preventing The Opioid Epidemic (TAPTOE). consortium, Utrecht, the Netherlands;Department of Psychiatry, Radboud University Medical Center, Nijmegen, the Netherlands;Donders Center for Medical Neuroscience, Donders Institute for Brain, Cognition and Behavior, Nijmegen, the Netherlands;Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Nijmegen, the Netherlands;

关键词: Chronic pain;    Fibromyalgia;    Opioids;    Cannabis;    Adverse effects;    Pain relief;    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07078-6

 received in 2022-10-11, accepted in 2023-01-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundOpioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous adverse effects, and are difficult to wean. As an alternative, we previously showed advantages of using pharmaceutical-grade cannabis in a population of chronic pain patients with fibromyalgia. It remains unknown whether combining an opioid with pharmaceutical-grade cannabis has advantages, such as fewer side effects from lesser opioid consumption in chronic pain.MethodsTrial design: a single-center, randomized, three-arm, open-label, exploratory trial.Trial population: 60 patients with fibromyalgia according to the 2010 definition of the American College of Rheumatologists.Intervention: Patients will be randomized to receive up to 4 daily 5 mg oral oxycodone sustained release (SR) tablet, up to 5 times 150 mg inhaled cannabis (Bediol®, containing 6.3% Δ9-tetrahydrocannabinol and 8% cannabidiol), or the combination of both treatments. Treatment is aimed at self-titration with the daily maximum doses given. Treatment will continue for 6 weeks, after which there is a 6-week follow-up period.Main trial endpoint: The number of side effects observed during the course of treatment using a composite adverse effect score that includes the following 10 symptoms: dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, and paranoia.Secondary and tertiary endpoints include pain relief and number of oxycodone doses and cannabis inhalations.DiscussionThe trial is designed to determine whether self-titration of oxycodone and cannabis will reduce side effects in chronic pain patients with fibromyalgia.Trial registration {2a and 2b}EU trial register 2019–001861-33, URL https://www.clinicaltrialsregister.eu, on July 17, 2019; World Health Organization International Clinical Trials Research Platform NL7902, URL https://trialsearch.who.int, on July 26, 2019.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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