PRIMARY STUDY
Cannabis combined with oxycodone for pain relief in fibromyalgia pain: a randomized clinical self-titration trial with focus on adverse events
Key Findings: Comparing the efficacy of oxycodone to inhaled cannabis in patients with pain from fibromyalgia this study found that cannabis combined with oxycodone offered no advantage over either treatment alone. There was however a reduction in opioid tablet intake, however, cannabis was poorly tolerated leading to treatment discontinuation in one-third of the patients.
Type of Study: Clinical Trial
Study Sample Size: 81
Study Result: Negative
Research Location(s): Netherlands, United States
Year of Pub: 2024
Cannabinoids Studied: Cannabidiol (CBD), Tetrahydrocannabinol (THC)
Phytocannabinoid Source: Cannabis Flower derived
Chemotype: Chemotype II
Terpenes Studied: ß-Caryophyllene, Myrcene, Ocimene, Pinene, Terpineol, Terpinolene
DOSING DETAILS 
Study Dosing Objective: Effective Dose, Safety Profile,
Established Protocol: No effective dose
Route of Administration: Inhalation
Cannabinoid Ratio: (THC : CBD) 63 : 80 
Dosage Form: capsules that contained 150 mg of cannabis (Bediol), these capsules could be placed in a hand-held vaporizer, 6.3% THC (9.5 mg) and 8% CBD (12 mg)
Dosing Regimen: Three groups: - 5 mg oxycodone tablets (max. four times/day), - 150 mg of inhaled cannabis containing 6.3% Δ9-tetrahydrocannabinol and 8% cannabidiol (max. times inhalation sessions/day) - a combination of both
Treatment Duration: for 6 weeks
Clinical Relevance: Cannabis was not more effective than oxycodone for chronic pain of fibromyalgia, and had worse side-effects.
Adverse Events: sleepiness, headache, insomnia, dizziness, constipation, paranoia and hallucinations, drug high, vomiting
Citation: van Dam CJ, Kramers C, Schellekens A, Bouvy M, van Dorp E, Kowal MA, Olofsen E, Dahan A, Niesters M, van Velzen M. Cannabis combined with oxycodone for pain relief in fibromyalgia pain: a randomized clinical self-titration trial with focus on adverse events. Front Pain Res (Lausanne). 2024 Nov 25;5:1497111. doi: 10.3389/fpain.2024.1497111. PMID: 39654798; PMCID: PMC11625723.
