Cannabis oral spray trial promising for severe pain patients
Suffering from chronic pain impacts every aspect of daily life. Routine tasks like cleaning the house can feel like summiting a great peak. Also, a person who doesn’t feel well all day can often be in a sour mood, sometimes straining relationships.
There are pain management pharmaceuticals, but many are prone to addiction or don’t work for certain patients. Imagine cannabis had the pharmacokinetic power to help. A clinical trial recently published in Volume 6 of Medical Cannabis and Cannabinoids shows that it might.
The clinical trial aimed to analyze the safety of Cybis® 10:25, a pharmaceutical cannabis product made in Australia. Cybis® 10:25 is an oral spray with 10mg THC, 25mg CBD, and 1mg linalool, a terpene found in lavender.
Cybis® 10:25 is manufactured by Cymra Life Sciences Ltd., which leads us to a glaring but not damning conflict of interest. Cymra funded the study and the scientists who designed and executed it work there. The Bellberry Human Research Ethics Committee reviewed the trial to keep everything above board.
Now that that’s out of the way, let’s see what they found out.
Who were the study participants?
Forty pain patients were screened to join the non-randomized, single-arm, open-label study– 28 were accepted into the trial. Those who were chosen averaged 63 years old, with an equal number of men and women. Participants were Asian and Caucasian.
To qualify, patients could not already be consuming cannabis in any form. Only four participants had any experience with the plant. They also must have been struggling with neck or back pain for at least the last three months.
Participants mostly listed pain levels as “severe,” with a few topping at “very severe,” and a total of eight reporting pain as “moderate.” Only four listed their pain as neuropathic, but pain descriptions were listed as “missing” for 18 participants.
Every participant had ratings between five and nine on the 1-10 numerical pain scale, and reported that NSAIDs and OTC paracetamol weren’t cutting it. Those taking other pain management drugs stopped for the study.
Alcohol was also on the list of “dont’s.” All participants also agreed not to drive a motor vehicle from the first dose to seven days after the last one.
Dosing, efficacy, and adverse side effects
Patients were given four escalating doses of Cybis® 10:25. starting at 0.5mL once a day, then 0.5mL twice a day. From there, twice-daily doses increased to 1mL and ended at 1.5mL.
Blood samples were drawn prior to dosing, 15 minutes after dosing, and then every half hour after that for nine hours. This was followed by a few more blood tests the following day. This timing varied anywhere from five to ten minutes for individual patients.
All doses showed “significant reductions in pain,” with the 1.0mL and 1.5mL options being the most effective. Patient self-reported pain dropped an average of 2.3 points on the number scale.
Patients reported a lower severity of neck and back pain and less pain during daily activities like work and walking. Overall, participants reported an increased enjoyment of life.
Sleep was also monitored during the trial. Though more sleep disturbances were reported, the higher the dose, the more likely patients reported their rest as “adequate.” Anxiety, depression, and stress were also alleviated, according to participant testimony.
There were 23 adverse events affecting 83 percent of the cohort. These included nausea, dizziness, and headache. The study marked all adverse events as “mild” or “moderate” aside from a severe case of kidney stones and one of passing out. Some participants reported anxiety and constipation.
Overall, researchers marked the drug as “well tolerated.”Despite some annoying but manageable side effects, a 10mg to 25mg dose of THC to CBD improved multiple areas of life for patients with chronic, intense neck and back pain.
With doctors reliant on science-based research to prescribe cannabis, research like this can open more doors for patients seeking alternative pain medications.
After decades of over-prescribing opioids, having more options for pain management is essential. This research adds to the body of proof that cannabis could be a valuable tool in the battle against opioid addiction.