Chronic pain is defined as pain lasting longer than three months, affects ~20% of Canadian
adults. In addition to having a significant negative impact at the individual patient level
(i.e., decreased quality of life and functioning), chronic pain is also a main cause of
disability and health care use. Opioids are frequently prescribed to manage chronic pain
despite limited data on their long term usefulness and has become one of the major
contributors to the current opioid crisis in Canada. Chronic pain can potentially be treated
with medical cannabis as an adjunct or alternative to opioids due to their similar
behavioral, anatomical and biochemical mechanisms. Cannabinoids also potentially prevent the
development of tolerance to opioids when co-administered.
Cannabinoids have demonstrated the ability to reduce pain as well as opioid-sparing effects
in pre-clinical and clinical studies however further research is needed to identify the
optimal make-up, ratio, and dosage of cannabinoids to minimize harms and maximize benefits.
Furthermore, studies conducted to date have methodological problems such as short follow-up
windows (hours or days) that limit conclusions. The investigators therefore propose a
randomized, placebo-controlled trial of oral cannabinoids [CBD (cannabidiol) alone or in
combination with THC (delta-9-tetrahydrocannabinol)] for reducing pain disability and opioid
use for pain management in chronic pain. However, there are a number of feasibility issues
that should be addressed prior to launching a full-scale trial in this area. Some issues have
been identified in the literature (e.g., success of blinding) while others are related to the
changing socio-medico-legal landscape surrounding cannabis use in Canada.
The purpose of this pilot study is to test the study plan, patient recruitment and compliance
with the study procedures. Results of this study may be used as a guide for larger studies
and will help us determine if medical cannabis can reduce daily opioid doses and/or decrease
pain interference (disability) in chronic pain patients.
This study will aim to recruit 51 patients from the Toronto General Hospital Transitional
Pain Service.
Study Procedure: After obtaining the Informed consent, patients will be randomized into one
of the three study groups. Patients will either receive CBD oil, CBD+THC oil or placebo
orally for 12 weeks. Starting dose will be 1 ml per day. The dose of study drug will be
adjusted based on patients' reported efficacy and adverse effects. After starting the study
drug, patients will have scheduled study visits either remotely or in-person at 4, 8, and 12
weeks plus a follow up calls or virtual clinic visit(OTN) at 2 and 6 weeks. At every study
visit, patients will be asked to complete the questionnaires that will assess their pain
level and how it affects their quality of life, opioid use, and side effects if they are
experiencing. The investigators will also collect information on: demographic and baseline
characteristics (e.g., sex, age, height, weight, and body mass index) and medical history
(including prior and concomitant medications) via patient interview or from inspection of
medical records. Additionally, symptoms of depression and anxiety will be measured with the
validated screening tools at baseline and 12 weeks post-treatment.
