Eugenia Oviedo-Joekes1, Suzanne Brissette2, Scott MacDonald3, Daphne Guh4, Kirsten Marchand5, Salima Jutha4, Scott Harrison3, Amin Janmohamed4, Derek Z Zhang4, Aslam H Anis5, Michael Krausz6, David C Marsh7, Martin T Schechter5. 1. Centre for Health Evaluation and Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St., Vancouver, BC, V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. Electronic address: eugenia@cheos.ubc.ca. 2. Centre de recheche du Centre Hospitalier de l'Université de Montréal, (CRCHUM), 900 St-Denis, Montréal, QC, H2X 0A9, Canada. 3. Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6 B 1G6, Canada. 4. Centre for Health Evaluation and Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St., Vancouver, BC, V6Z 1Y6, Canada. 5. Centre for Health Evaluation and Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St., Vancouver, BC, V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. 6. Centre for Health Evaluation and Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St., Vancouver, BC, V6Z 1Y6, Canada; Department of Psychiatry, Faculty of Medicine, Detwiller Pavilion 2255 Wesbrook Mall, Vancouver, BC V6T 2A1, Canada. 7. Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON P3E 2C6, Canada.
Abstract
AIMS: To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance. METHODS: This was a non-inferiority randomized double-blind controlled trial (Vancouver, Canada) testing hydromorphone (n=100) and diacetylmorphine (n=102) for the treatment of severe opioid use disorder. Medications were delivered under the supervision of trained Registered Nurses up to three times daily. AEs were described using MedDRA codes. RESULTS: Most common related AEs included immediate post-injection reaction or injection site pruritus reactions, somnolence and opioid overdoses. Adjusted analysis indicated that participants in the hydromorphone group were less likely to have any related AE or SAE compared to the diacetylmorphine group. Related somnolence and opioid overdose events were distributed throughout the six months treatment period. In the diacetylmorphine group, five of the eleven related SAE opioid overdoses (requiring naloxone) occurred in the first 30days since most recent treatment initiation. Analysis of somnolence and opioid overdose (AEs and SAEs) event rates by received dose suggested a non-linear relationship. However, in the diacetylmorphine group higher event rates per person days were recorded at lower doses. CONCLUSIONS: When injectable hydromorphone and diacetylmorphine are individually dosed and monitored, their opioid-related side effects, including potential fatal overdoses, are safely mitigated and treated by health care providers. In the midst of an opioid overdose epidemic, injectable options are timely to reach a very important minority of people who inject street opioids and are not attracted to other treatments.
RCT Entities:
AIMS: To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance. METHODS: This was a non-inferiority randomized double-blind controlled trial (Vancouver, Canada) testing hydromorphone (n=100) and diacetylmorphine (n=102) for the treatment of severe opioid use disorder. Medications were delivered under the supervision of trained Registered Nurses up to three times daily. AEs were described using MedDRA codes. RESULTS: Most common related AEs included immediate post-injection reaction or injection site pruritus reactions, somnolence and opioid overdoses. Adjusted analysis indicated that participants in the hydromorphone group were less likely to have any related AE or SAE compared to the diacetylmorphine group. Related somnolence and opioid overdose events were distributed throughout the six months treatment period. In the diacetylmorphine group, five of the eleven related SAEopioid overdoses (requiring naloxone) occurred in the first 30days since most recent treatment initiation. Analysis of somnolence and opioid overdose (AEs and SAEs) event rates by received dose suggested a non-linear relationship. However, in the diacetylmorphine group higher event rates per person days were recorded at lower doses. CONCLUSIONS: When injectable hydromorphone and diacetylmorphine are individually dosed and monitored, their opioid-related side effects, including potential fatal overdoses, are safely mitigated and treated by health care providers. In the midst of an opioid overdose epidemic, injectable options are timely to reach a very important minority of people who inject street opioids and are not attracted to other treatments.
Authors: Miriam Th Harris; Rebecca K Seliga; Nadia Fairbairn; Seonaid Nolan; Alexander Y Walley; Zoe M Weinstein; Jeffery Turnbull Journal: Int J Drug Policy Date: 2021-08-30
Authors: Michelle Olding; Andrew Ivsins; Samara Mayer; Alex Betsos; Jade Boyd; Christy Sutherland; Coco Culbertson; Thomas Kerr; Ryan McNeil Journal: Am J Public Health Date: 2020-04-16 Impact factor: 9.308
Authors: Eugenia Oviedo-Joekes; Heather Palis; Daphne Guh; David C Marsh; Scott MacDonald; Scott Harrison; Suzanne Brissette; Aslam H Anis; Martin T Schechter Journal: J Addict Med Date: 2019 Sep/Oct Impact factor: 3.702