{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T13:32:56Z","timestamp":1791379976883,"version":"4.3.3"},"reference-count":20,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T00:00:00Z","timestamp":1732492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pain Res."],"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>We determined whether adding cannabis to oxycodone for chronic non-cancer pain management could reduce treatment-related adverse effects (AEs) while maintaining effective analgesia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this open-label study, fibromyalgia patients aged \u226518\u2005years were randomized to receive 5 mg oxycodone tablets (max. four times\/day), 150\u2005mg of inhaled cannabis containing 6.3% \u0394<jats:sup>9<\/jats:sup>-tetrahydrocannabinol and 8% cannabidiol (max. times inhalation sessions\/day), or a combination of both for 6\u2005weeks. The primary endpoint was treatment-related adverse events, assessed using a 10-point composite adverse event (cAE) score; additionally, we recorded daily reported pain relief and daily tablet and cannabis consumption.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 23 patients were treated with oxycodone, 29 with cannabis, and 29 with the oxycodone\/cannabis combination. Three patients from the oxycodone group (13%) and 18 patients from the cannabis groups (31%, 9 in each group) withdrew from the trial within 2\u20133\u2005weeks because of the severity of AEs. There were no differences in treatment-related cAE scores among the three groups that completed the study (<jats:italic>p<\/jats:italic>\u2009=\u20090.70). The analgesic responder rate showed a \u22651- point reduction in pain in 50% and a \u22652-point reduction in 20% of patients, while 50% of patients experienced no treatment benefit. The combination treatment reduced oxycodone tablet consumption by 35% (<jats:italic>p<\/jats:italic>\u2009=\u20090.02), but it did not affect the number of cannabis inhalation sessions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Cannabis combined with oxycodone offered no advantage over either treatment alone, except for a reduction in opioid tablet intake; however, the overall drug load was the highest in the combination group. Moreover, cannabis was poorly tolerated and led to treatment discontinuation in one-third of participants treated with cannabis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>The trial was registered at the WHO International Clinical Trials Registry Platform (<jats:uri>trialsearch.who.int<\/jats:uri>) on July 26, 2019, identifier NL7902.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpain.2024.1497111","type":"journal-article","created":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T06:24:49Z","timestamp":1732515889000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Cannabis combined with oxycodone for pain relief in fibromyalgia pain: a randomized clinical self-titration trial with focus on adverse events"],"prefix":"10.3389","volume":"5","author":[{"given":"Cornelis Jan","family":"van 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