TY - JOUR
T1 - Clinical Outcome Data of First Cohort of Chronic Pain Patients Treated With Cannabis-Based Sublingual Oils in the United Kingdom
T2 - Analysis From the UK Medical Cannabis Registry
AU - Kawka, Michal
AU - Erridge, Simon
AU - Holvey, Carl
AU - Coomber, Ross
AU - Usmani, Azfer
AU - Sajad, Mohammad
AU - Platt, Michael W
AU - Rucker, James J
AU - Sodergren, Mikael H
N1 - Funding Information:
M.K. is a medical student at Imperial College London. He has no shareholdings in pharmaceutical companies. S.E. is a junior doctor and undertakes paid consultancy work at Sapphire Medical Clinics. He is an honorary clinical research fellow at Imperial College London. He has no shareholdings in pharmaceutical companies. C.H. is chief clinical pharmacist at Sapphire Medical Clinics. He has no shareholdings in pharmaceutical companies. R.C. is a consultant orthopedic surgeon, a director, and a shareholder at Sapphire Medical Clinics and a consultant at St George's Hospital, London. He has no shareholdings in pharmaceutical companies. A.U. is a pain specialist at Sapphire Medical Clinics (London) and a consultant at Dartford and Gravesham NHS Trust. He has no shareholdings in pharmaceutical companies. M.S. is a pain specialist at Sapphire Medical Clinics (London) and a consultant at Dudley Group of Hospitals NHS Trust. He has no shareholdings in pharmaceutical companies. M.P. is a consultant in pain services and a director and a shareholder at Sapphire Medical Clinics (London). He has no shareholdings in pharmaceutical companies. J.R. is a consultant psychiatrist, a director, and a shareholder at Sapphire Medical Clinics (London). He is an honorary consultant psychiatrist at the South London & Maudsley NHS Foundation Trust, and a National Institute for Health Research (NIHR) Clinician Scientist Fellow at the Centre for Affective Disorders at King's College London. He is funded by a fellowship (CS‐2017‐17‐007) from the NIHR. He leads the Psychedelic Trials Group at King's College London. King's College London receives grant funding from COMPASS Pathways PLC to undertake phase 1 and phase 2 trials with psilocybin. COMPASS Pathways PLC has paid for him to attend trial‐related meetings and conferences to present the results of research using psilocybin. He has undertaken paid consultancy work for Beckley PsyTech and Clerkenwell Health. Payments for consultancy work are received and managed by King's College London, and he does not benefit personally. He has no shareholdings in pharmaceutical companies. M.S. is a consultant hepatopancreatobiliary surgeon at Imperial College Healthcare NHS Trust, London, and a Senior Clinical Lecturer at Imperial College London. He is a founder, director, and a shareholder at Sapphire Medical Clinics and Research Director at Curaleaf International. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health.
Publisher Copyright:
© 2021 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology
PY - 2021/12
Y1 - 2021/12
N2 - Cannabis-based medicinal products (CBMPs) are an emerging therapeutic option in the management of primary chronic pain, using the role of the endocannabinoid system in modulating central and peripheral pain processes. Despite promising preclinical data, there is a paucity of high-quality evidence to support the use of CBMPs for chronic pain. This study aimed to investigate the health-related quality-of-life outcomes of patients with chronic pain who were prescribed CBMP oil preparations (Adven, Curaleaf International, Guernsey, UK). This study is a case series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short form, Short-Form McGill Pain Questionnaire-2, Visual Analog Scale Pain, General Anxiety Disorder-7, Sleep Quality Scale, and EQ-5D-5L, at 1, 3, and 6 months. One hundred ten patients were included. Significant improvements in Sleep Quality Scale, EQ-5D-5L pain and discomfort subscale, and Brief Pain Inventory Interference Subscale (P < .05) at 1, 3, and 6 months were demonstrated. There were no notable differences between cannabis-naïve and previous cannabis users in quality-of-life outcomes. The adverse event incidence was 30.0%, with most (n = 58; 92.1%) adverse events being mild or moderate in intensity. Treatment of chronic pain with Adven CBMP oils was associated with an improvement in pain-specific outcomes, health-related quality of life, and self-reported sleep quality. Relative safety was demonstrated over medium-term prescribed use. While these findings must be treated with caution considering the limitations of study design, they can inform future clinical trials.
AB - Cannabis-based medicinal products (CBMPs) are an emerging therapeutic option in the management of primary chronic pain, using the role of the endocannabinoid system in modulating central and peripheral pain processes. Despite promising preclinical data, there is a paucity of high-quality evidence to support the use of CBMPs for chronic pain. This study aimed to investigate the health-related quality-of-life outcomes of patients with chronic pain who were prescribed CBMP oil preparations (Adven, Curaleaf International, Guernsey, UK). This study is a case series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short form, Short-Form McGill Pain Questionnaire-2, Visual Analog Scale Pain, General Anxiety Disorder-7, Sleep Quality Scale, and EQ-5D-5L, at 1, 3, and 6 months. One hundred ten patients were included. Significant improvements in Sleep Quality Scale, EQ-5D-5L pain and discomfort subscale, and Brief Pain Inventory Interference Subscale (P < .05) at 1, 3, and 6 months were demonstrated. There were no notable differences between cannabis-naïve and previous cannabis users in quality-of-life outcomes. The adverse event incidence was 30.0%, with most (n = 58; 92.1%) adverse events being mild or moderate in intensity. Treatment of chronic pain with Adven CBMP oils was associated with an improvement in pain-specific outcomes, health-related quality of life, and self-reported sleep quality. Relative safety was demonstrated over medium-term prescribed use. While these findings must be treated with caution considering the limitations of study design, they can inform future clinical trials.
UR - http://www.scopus.com/inward/record.url?scp=85116345694&partnerID=8YFLogxK
U2 - 10.1002/jcph.1961
DO - 10.1002/jcph.1961
M3 - Article
C2 - 34473850
SN - 0091-2700
VL - 61
SP - 1545
EP - 1554
JO - Journal of Clinical Pharmacology
JF - Journal of Clinical Pharmacology
IS - 12
ER -