Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate the safety and efficacy of different formulations of medical cannabis oil to reduce chronic pain intensity. The study will be conducted at Santé Cannabis Clinic, the only medical cannabinoid therapy clinic, located in Montreal, Quebec. One hundred and sixty consecutive adult patients, male and female, with chronic non-cancer and cancer pain (at least 3 months in duration), with an average weekly pain intensity score greater than 4 on the 11 points NRS, will be prospectively recruited and invited to participate in this trial. Informed consent will be obtained by a Research Assistant. After baseline documentation with standardized scales, patients will be randomized to one of 4 parallel groups: * Group A: THC/CBD ratio 1:1 capsule * Group B: THC/CBD ratio 1:2 capsule * Group C: THC/CBD ratio 0.1:2 capsule * Group D: Placebo capsule Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis. Follow-up visits will be done after 1 week and 6 weeks of treatment. At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, the investigator may propose one of the cannabis oils to the subject if they feel it may potentially provide benefits. They will take this new treatment for other 12 weeks. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
capsule containing cannabis oil
capsule containing cannabis oil
capsule containing cannabis oil
carrier oil capsule
Santé Cannabis
Montreal, Quebec, Canada
Does the daily use of cannabis oil improves chronic pain
Changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) scale. Scale range is 0 to 10; 0 (No pain) being the best rating to the maximal rating of 10 (Pain as bad as you can imagine).
Time frame: Change from Baseline in BPI-SF at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improves chronic pain
Changes in pain as measured by the Numerical Rating Scale (NRS). The NRS is a measure of the average weekly pain intensity score greater than on a 0 to 10 points scale where 0 is No Pain and 10 is the worst pain.
Time frame: Change from Baseline in NRS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve symptom burden
Changes in symptom burden as measured by the revised Edmonton Symptom Assessment System version with Constipation and Sleep was added to assess improvement in symptom burden (ESAS-r-CS). Scale range is 0 to 10; 0 (No symptom) being the best rating to the maximal rating of 10 (Worst possible score for symptom).
Time frame: Change from Baseline in ESAS-r-CS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability).
Changes in validated UKU Side Effects Rating Scale for Patients (UKU-SERS-Pat). Scale range is 0 to 3 for rating the degree of severity and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.
Time frame: Change from Baseline in UKU-SERSP at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve cognition
Changes in validated Mini-Cog. Scale range is numerical and rates the ability to recall words and ability to draw a clock showing numbers from 1 to 12 and then drawing the given time.
Time frame: Change from Baseline in Mini-Cog at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil reduce the Profile of Mood States (POMS)
Changes in POMS . Scale range is 1 to 5 and describes how you feel right now. Scale of 1, the lowest score, describes a feeling of Not At All right now for the mood and the scale of 5 gives the highest score representing a feeling of Extremely for the mood.
Time frame: Change from Baseline in POMS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve the Hamilton Rating Scale for Depression (HAM-D)
Changes in HAM-D scale. Scale range is either 0 to 2 or 0 to 4. The scale is designed to rate the severity of depression with a score of 0 representing the absence of the question and 2 or 4 meaning the highest severity.
Time frame: Change from Baseline in HAM-D at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
Does the daily use of cannabis oil improve Medication Quantification Scale (MQS) version III
Changes in concurrent medications, rescue medications and Medication Quantification Scale (MQS) version III. MQS is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed.
Time frame: Change from Baseline in MQS version III at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.