PMID- 37007688
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230404
IS  - 2048-8505 (Print)
IS  - 2048-8513 (Electronic)
IS  - 2048-8505 (Linking)
VI  - 16
IP  - 4
DP  - 2023 Apr
TI  - Medical cannabis for pain management in patients undergoing chronic hemodialysis: 
      randomized, double-blind, cross-over, feasibility study.
PG  - 701-710
LID - 10.1093/ckj/sfac275 [doi]
AB  - 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.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the ERA.
FAU - Kliuk-Ben Bassat, Orit
AU  - Kliuk-Ben Bassat O
AD  - Department of Nephrology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
AD  - Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Schechter, Meir
AU  - Schechter M
AD  - Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical 
      Center, Jerusalem, Israel.
AD  - Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
FAU - Ashtamker, Natalia
AU  - Ashtamker N
AD  - BOL Pharma, Ltd, Revadim, Israel.
FAU - Yanuv, Ilan
AU  - Yanuv I
AD  - Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical 
      Center, Jerusalem, Israel.
AD  - Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
FAU - Rozenberg, Aliza
AU  - Rozenberg A
AD  - Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical 
      Center, Jerusalem, Israel.
AD  - Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
FAU - Hirshberg, Boaz
AU  - Hirshberg B
AD  - BOL Pharma, Ltd, Revadim, Israel.
FAU - Grupper, Ayelet
AU  - Grupper A
AUID- ORCID: 0000-0002-6690-9428
AD  - Department of Nephrology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
AD  - Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Vaisman, Nachum
AU  - Vaisman N
AD  - Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
AD  - Department of Gastroenterology and Liver Disease, Tel Aviv Sourasky Medical 
      Center, Tel Aviv, Israel.
FAU - Brill, Silviu
AU  - Brill S
AD  - Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
AD  - Pain Institute, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.
FAU - Mosenzon, Ofri
AU  - Mosenzon O
AD  - Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical 
      Center, Jerusalem, Israel.
AD  - Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
LA  - eng
PT  - Journal Article
DEP - 20221223
PL  - England
TA  - Clin Kidney J
JT  - Clinical kidney journal
JID - 101579321
PMC - PMC10061437
OTO - NOTNLM
OT  - ESKD
OT  - cannabis
OT  - end-stage kidney disease
OT  - hemodialysis
OT  - pain
COIS- N.A. is an employee of BOL Pharma Ltd. N.V. and B.H. are former employees of BOL 
      Pharma Ltd. O.M. is a former employee of BOL; Advisory Board: Novo Nordisk, Eli 
      Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Novartis, AstraZeneca, 
      Bayer, BOL Pharma; Research grant: Novo Nordisk, AstraZeneca; Speakers Bureau: 
      Novo Nordisk, AstraZeneca, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer 
      Ingelheim.
EDAT- 2023/04/04 06:00
MHDA- 2023/04/04 06:01
PMCR- 2022/12/23
CRDT- 2023/04/03 04:02
PHST- 2022/08/29 00:00 [received]
PHST- 2023/04/04 06:01 [medline]
PHST- 2023/04/03 04:02 [entrez]
PHST- 2023/04/04 06:00 [pubmed]
PHST- 2022/12/23 00:00 [pmc-release]
AID - sfac275 [pii]
AID - 10.1093/ckj/sfac275 [doi]
PST - epublish
SO  - Clin Kidney J. 2022 Dec 23;16(4):701-710. doi: 10.1093/ckj/sfac275. eCollection 
      2023 Apr.