It has long been challenging for researchers to put medical cannabis through well-controlled clinical trials. For starters, the strict scheduling of cannabis at the federal level has limited the scope of any investigation over the last few decades.
Moreover, cannabis is a chemically variable plant, and there can be dilemmas regulating dose size from one test subject to the next. Trying to control for all these variables within a clinical setting has proven difficult.
Yet, as legislative barriers fall and new precision dose control technologies like the RYAH Smart Inhaler come into play, clinical research is plowing ahead. By some estimates, funding for cannabis-focused research has more than quadrupled since 2000. Globally, the barriers to well-controlled cannabis research are melting away.
A Brief History of Cannabis Clinical Trials
Historically, most cannabis-focused studies, in order to receive any funding or regulatory approval, were distinctly anti-cannabis in nature. That typically meant looking at cannabis-related crime, cannabis intoxication/abuse, and cannabis use among adolescents.
Recently, Dr. Jim Hudson and his consultancy launched Health, which assessed the funding for cannabis-based research in the UK, US, and Canada between 2000 and 2018. During this 18-year time frame, more than $1.5 billion went to investigating cannabis, with the vast majority of funding in the US, from the National Institute of Health.
On the surface, this looks positive, but as Hudson and his team crunched the numbers, they determined the focus of this research was not so much on the plant’s medicinal benefits but on the potential harmful effects. Although the total funding on cannabis research has reached record levels, Hudson’s research confirms the potential harms of cannabis still received 20 times more funding than cannabis for medicine did.
But as strict scheduling, societal opinions, and technological barriers begin to fall, controlled study into this plant’s therapeutic benefits is getting underway.
Current State of Cannabis Clinical Trials in 2021
A quick search of cannabis-focused clinical trials in the US reveals that most completed studies to date have investigated various aspects of cannabis dependence and cannabis abuse disorder. But, a few interesting results have been published that begin to examine the medicinal side instead.
A decade ago, a study looked at smoked cannabis for neuropathic pain. In one of the few trials to work with smoked cannabis, instead of a vaporizer or oral extractions, the researchers aimed to determine if cannabis flower would reduce post-traumatic or post-surgical neuropathic pain.
Twenty-three participants were assigned one of four THC potencies (0%, 2.5%, 6%, and 9.4% THC) over four 14-day periods in a crossover trial. While this was a relatively small clinical trial, the authors concluded, “A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated.”
Another, more recently completed clinical trial published results in late 2020. Researchers published “Effect of Inhaled Cannabis for Pain in Adults With Sickle Cell Disease: A Randomized Clinical Trial” on JAMA Network Open. Twenty-three patients with sickle cell disease and chronic pain completed this first-of-its-kind crossover study. Participants were given low-THC cannabis three times daily for five days through a vaporizer.
After data collection and assessment, the research team reported that “compared with vaporized placebo, vaporized cannabis did not statistically significantly reduce pain and associated symptoms, except interference in mood, in patients with SCD with chronic pain.”
Outside of the US, there are a few more cannabis clinical trials already completed in cannabis-friendly markets like Canada and Israel. There is an urgent need to examine the therapeutic side of this plant, considering there are already likely millions of patients around the world relying on cannabis for the relief of chronic conditions.
Largest Clinical Trial of its Kind Kicking off in the UK
As announced back in 2019, RYAH is pleased to be working with an international clinic based in the UK, on one of the largest and most comprehensive clinical trials in plant-based medicine. In the spring of 2021, the first 10,000 dry-herb cartridges and QR codes shipped out, with approximately 100,000 RYAH Smart inhalers also on schedule to support the study.
This study is based at a major oncology clinic and aims to explore the efficacy and safety of cannabis to treat patients suffering from chronic pain. Eventually, over the five-year study, the clinic seeks to work with tens of thousands of pain patients.
RYAH will supply IoT-controlled Smart Inhalers with a fully customized software solution and direct API data integration with the Clinic’s Electronic Health Record (EHR) system. This means researchers will better protect participant privacy, mitigate the number of variables associated with cannabis consumption, and make scaling the trial relatively simple.
A Bright Future for Cannabis Clinical Trials
Until recently, restrictive funding and legislative barriers made it difficult to explore the benefits of medical cannabis. But, these constraints are rapidly disappearing. Increasingly, both funding and technological support are available for clinical trials focused on cannabis’ therapeutic potential.
At the time of writing, the national clinical trials database lists more than 400 studies on cannabis within the recruitment or study phase. Not to mention the many more getting underway in Canada, the UK, and Israel. Finally, research is moving beyond cannabis’ issues as a recreational drug to better understand this plant’s therapeutic benefits.