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CLINICAL TRIAL article

Front. Pain Res.
Sec. Pharmacological Treatment of Pain
Volume 5 - 2024 | doi: 10.3389/fpain.2024.1497111

Cannabis combined with oxycodone for pain relief in fibromyalgia pain: a randomized clinical self-titration trial with focus on adverse events

Provisionally accepted
Cornelis J. van Dam Cornelis J. van Dam 1Cornelis Kramers Cornelis Kramers 2Arnt Schellekens Arnt Schellekens 2Marcel Bouvy Marcel Bouvy 3Eveline Van Dorp Eveline Van Dorp 1Mikael A. Kowal Mikael A. Kowal 4Erik Olofsen Erik Olofsen 1Albert Dahan Albert Dahan 1,5*Marieke Niesters Marieke Niesters 1Monique Van Velzen Monique Van Velzen 1
  • 1 Leiden University, Leiden, Netherlands
  • 2 Radboud University, Nijmegen, Gelderland, Netherlands
  • 3 Utrecht University, Utrecht, Netherlands, Netherlands
  • 4 Bedrocan International, Veendam, Netherlands
  • 5 Leiden University Medical Center (LUMC), Leiden, Netherlands

The final, formatted version of the article will be published soon.

    Objectives: We determine whether adding cannabis to oxycodone for chronic noncancer pain management would reduce treatment-related adverse effects (AEs) while maintaining analgesia.In this open-label study, fibromyalgia patients, aged ³18 years, were randomized to receive 5-mg oxycodone tablets (max. 4-times/day), 150 mg inhaled cannabis containing 6.3% D 9 -tetrahydro-cannabinol and 8% cannabidiol (max. 5 inhalation sessions/day) or their combination, for 6-weeks. The main endpoint was treatment-related adverse events reported using a 10-point composite adverse event score (cAE); additionally, we collected daily reported pain relief and daily tablet and cannabis consumption.Results: Twenty-three patients were treated with oxycodone, 29 with cannabis and 29 with the oxycodone/cannabis combination. Three patients treated with just oxycodone (13%) and 18 patients treated with cannabis (31%, 9 in either groups) dropped out of the trial within 2-3 weeks because of severity of AEs. There were no differences in treatment-related cAEs among the three groups that completed the study (p=0.70). The analgesic responder rate was ³1 pain point reduction in 50% and ³2 points reduction in 20% of patients; 50% of patients were without treatment benefit. The treatment combination reduced oxycodone tablet consumption by 35% (p=0.02) but not the number of cannabis inhalation sessions.Conclusions: Cannabis combined with oxycodone had no advantage over either treatment alone, apart from the reduced opioid tablets intake, albeit the overall drug load was highest in the combination group. Moreover, cannabis was poorly tolerated and led to treatment discontinuation in a third of participants treated with cannabis.

    Keywords: Cannabis, Oxycodone, self-totration, analgesoa, Adverse (side) effects

    Received: 16 Sep 2024; Accepted: 31 Oct 2024.

    Copyright: © 2024 van Dam, Kramers, Schellekens, Bouvy, Van Dorp, Kowal, Olofsen, Dahan, Niesters and Van Velzen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Albert Dahan, Leiden University Medical Center (LUMC), Leiden, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.