PMID- 36579921 OWN - NLM STAT- MEDLINE DCOM- 20231216 LR - 20240319 IS - 2378-8763 (Electronic) IS - 2578-5125 (Print) IS - 2378-8763 (Linking) VI - 8 IP - 6 DP - 2023 Dec TI - The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. PG - 1106-1116 LID - 10.1089/can.2022.0041 [doi] AB - Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age >/=18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications. FAU - Vigano, Antonio AU - Vigano A AD - Medical Cannabis Program in Oncology, Cedars Cancer Center, McGill University Health Centre, Montreal, Canada. FAU - Moride, Yola AU - Moride Y AD - Faculty of Pharmacy, University of Montreal, Montreal, Canada. AD - Rutgers The State University of New Jersey, Center for Pharmacoepidemiology and Treatment Science, New Brunswick, New Jersey, USA. FAU - Hachem, Yasmina AU - Hachem Y AUID- ORCID: 0000-0002-3475-8915 AD - Medical Cannabis Program in Oncology, Cedars Cancer Center, McGill University Health Centre, Montreal, Canada. FAU - Canac-Marquis, Michelle AU - Canac-Marquis M AD - Research Institute of the McGill University Health Centre, Montreal, Canada. FAU - Gamaoun, Rihab AU - Gamaoun R AD - Medical Cannabis Program in Oncology, Cedars Cancer Center, McGill University Health Centre, Montreal, Canada. FAU - Kalaba, Maja AU - Kalaba M AUID- ORCID: 0000-0002-3628-5197 AD - Canopy Growth Corporation, Smiths Falls, Canada. FAU - Martel, Marc O AU - Martel MO AD - Faculty of Dentistry & Department of Anesthesia, McGill University, Montreal, Canada. FAU - Perez, Jordi AU - Perez J AD - Alan Edwards Pain Management Unit, McGill University Health Centre, Montreal, Canada. FAU - Neron, Andree AU - Neron A AD - McGill University Health Centre, Montreal, Canada. FAU - Beaulieu, Pierre AU - Beaulieu P AD - Department of Anesthesiology & Pain Medicine, Universite de Montreal Faculte de Medecine, Montreal, Canada. FAU - Desroches, Julie AU - Desroches J AD - Departement de Pharmacologie, Universite de Montreal, Montreal, Canada. FAU - Ware, Mark AU - Ware M AD - Department of Family Medicine, McGil University, Montreal, Canada. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20221228 PL - United States TA - Cannabis Cannabinoid Res JT - Cannabis and cannabinoid research JID - 101684827 RN - 0 (Medical Marijuana) RN - 0 (Hallucinogens) SB - IM MH - Adult MH - Humans MH - Female MH - Middle Aged MH - Adolescent MH - Male MH - *Medical Marijuana/adverse effects MH - *Cannabis/adverse effects MH - Quebec/epidemiology MH - Quality of Life MH - Prospective Studies MH - Canada MH - Pain/drug therapy MH - *Hallucinogens MH - Fatigue/drug therapy MH - Registries PMC - PMC10714117 OTO - NOTNLM OT - effectiveness OT - medical cannabis OT - pain OT - quality of life OT - registry OT - safety COIS- M.W. initiated the QCR in 2015 and was the Principal Investigator until July 1, 2018, when he joined Canopy Growth Corporation, initially as Medical Director and most recently as Consultant. He has since served as a nonvoting Advisory Board member to the QCR. As of July 1, 2018, the QCR was lead by Dr. William Barakett (in memoriam) until March 2019 and is presently lead by A.V. A.V. is currently an advisory board member for EmpowerPharm and has formerly served in this capacity for Spectrum Therapeutics/Canopy Health, Tilray, Tetrabiopharma, Syqe. He was the former Research Director of Sante Cannabis in Montreal, Canada. Y.M. was a consultant for Spectrum Therapeutics/Canopy Health. No other authors have disclosures or conflicts of interest to declare. EDAT- 2022/12/30 06:00 MHDA- 2023/12/17 09:42 PMCR- 2024/12/04 CRDT- 2022/12/29 09:13 PHST- 2024/12/04 00:00 [pmc-release] PHST- 2023/12/17 09:42 [medline] PHST- 2022/12/30 06:00 [pubmed] PHST- 2022/12/29 09:13 [entrez] AID - 10.1089/can.2022.0041 [pii] AID - 10.1089/can.2022.0041 [doi] PST - ppublish SO - Cannabis Cannabinoid Res. 2023 Dec;8(6):1106-1116. doi: 10.1089/can.2022.0041. Epub 2022 Dec 28.