Medical cannabis for pain management in patients undergoing chronic hemodialysis: randomized, double-blind, cross-over, feasibility study
Orit Kliuk-Ben Bassat 1 2, Meir Schechter 3 4, Natalia Ashtamker 5, Ilan Yanuv 3 4, Aliza Rozenberg 3 4, Boaz Hirshberg 5, Ayelet Grupper 1 2, Nachum Vaisman 2 6, Silviu Brill 2 7, Ofri Mosenzon 3 4
- 1Department of Nephrology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
- 2Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
- 3Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.
- 4Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
- 5BOL Pharma, Ltd, Revadim, Israel.
- 6Department of Gastroenterology and Liver Disease, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
- 7Pain Institute, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.
Affiliationer
Background: Chronic pain is prevalent but difficult to treat in patients undergoing hemodialysis (HD). Effective and safe analgesics are limited in this patient population. Our aim in this feasibility study was to evaluate the safety of sublingual oil based medical cannabis for pain management in patients undergoing HD.
Methods: In a prospective randomized, double-blind, cross-over design, patients undergoing HD with chronic pain were assigned to one of three arms: BOL-DP-o-04-WPE whole-plant extract (WPE), BOL-DP-o-04 cannabinoid extraction (API) or placebo. WPE and API contained trans-delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:6 ratio (1:6, THC:CBD). Patients were treated for 8 weeks, with subsequent 2-week wash out, followed by a cross-over to a different arm. The primary endpoint was safety.
Results: Eighteen patients were recruited and 15 were randomized. Three did not complete drug titration period due to adverse events (AEs) and one patient died during titration due to sepsis (WPE). Of those who completed at least one treatment period, seven patients were in the WPE arm, five in the API and nine receiving placebo. The most common AEs were sleepiness, which improved after dose reduction or patient adaptation. Most AEs were mild to moderate and resolved spontaneously. Serious AEs considered related to study drug included one episode of accidental overdose (WPE) leading to hallucinations. Liver enzymes were stable during cannabis treatment.
Conclusions: Short-term medical cannabis use in patients treated with HD was generally well tolerated. The safety data supports further studies to assess the overall risk-benefit of a treatment paradigm utilizing medical cannabis to control pain in this patient population.
