Karhlyle Fletcher   |   November 30, 2021

Ongoing Clinical Trials for Cannabis Medicinal Potential

Uncovering the mysteries deep within its leaves, clinical trials with cannabis are putting science behind the claims.
Detroiter Karhlyle Fletcher is the host of High Lit, a cannabis research and classic literature podcast featuring leading voices and independent music. In addition to years in written and video cannabis journalism, he is also a traditional author.

While cannabis prohibition has not yet ended, many countries are advancing the substance as a legitimate medicine. As commonly stated, today's innovations rely on thousands of years of tradition. From ancient Chinese tombs to biblical references, cannabis has been part of the human story since the beginning - and now we are crystallizing our conception of why it is so beneficial.

Decades of Research Proves Value

Cannabis Science is a provocative subject not because there isn't a plethora of research already available but because much of the information was repressed prior to the widespread adoption of the internet and global scientific research. Despite restrictions, researchers in the US are doing some work to show the long-term implications of cannabis as medicine.

Consider the discovery of anandamide by Lumír Hanuš and William Devane. This endocannabinoid is instrumental in the understanding of the balance of the brain. However, this discovery relied on the discovery of cannabinoids.

Cannabinoids were reacting with the endocannabinoid system, and thus it followed that natural human chemicals had to exist to be used by this system. Through this research, we discovered the existence of endocannabinoids, and our understanding of the human body advanced.

Cannabis trials often advance critical aspects of science, even if mainstream cannabis pharmaceuticals are still a work in progress.

Mainstreaming Cannabis Research

In the United States, researching cannabis isn’t as easy as it sounds. Until recently, the red tape of prohibition dictated how, what, and from where cannabis was sourced for various studies. Plus, strict regulations limited and even restricted certain types of research.

However, as cannabis and hemp have started to gain legalization, much more research is being conducted.

For example, this clinical trial is recruiting to review the effects of Epidolex on the liver. Scheduled to be completed by the later part of the decade, this research is poised to be a valuable measure of cannabis' health effects. Yet, many approved pharmacological substances haven’t had the same scrutiny of side effects before widespread adoption. On that point, the cannabis industry operates differently, with an increased emphasis on testing and research due to its history as an illicit substance.

A new era has arrived as Pure Green, a pharmaceutical company, is working directly with the FDA. Led by a co-creator of methadone, Stephen Goldner, who has over 200 patents with the FDA, the company is poised to success. One Pure Green trial has already concluded, suggesting cannabinoids as an alternative option for treating diabetic neuropathy of the feet.

According to Goldner, the FDA was interested in working with his CBD-oriented company as the government is worried about the rising opiate addiction across the nation. So, with that in mind, it's obvious America is now looking for alternatives. The study by Pure Green concluded only one person had an adverse reaction - and they were taking a placebo. Otherwise, the effects of the CBD treatment were significant and promising for the treatment of chronic pain.

Ongoing Clinical Trials Showing Promise

As Raphael Mechoulam described cannabis's potential as an anti-epileptic back in the 1980s, many of the conditions that cannabis could treat are unsurprising. Cancer is always a hot-button topic, and the University of Colorado has an ongoing trial on Non-small Cell Lung Cancer. The research will enroll 30 eligible patients and undergo blood collection, questionnaires, and mental assessments at baseline and then 1 hour and 2 hours after using cannabis. In this trial, the emphasis is on the effects on quality of life and cognition. Asking if cannabis is a milder and more approachable alternative to other medications is a foundation question in cancer treatment. 

Control in trials like these is crucial, as the blood test is revealing. Too many studies rely on online questionnaires that may be fascinating but ultimately unreliable. Blood tests, electronic imagery, and other methods truly allow us a window into the mechanisms of cannabis.

Other high-powered studies include those using cannabis as a counterpoint to other medications such as this trial. Here cannabis is compared to dexamethasone, dronabinol, or mirtazapine. Reviewing cannabis against other traditional pharmacological agents is the best way to get an accurate picture of its impact and how it compares to other options.

Another ongoing trial will also be using blood samples. The property reviewed is the bioavailability of CBD in healthy controls. One of the groups tested will even eat a high-fat meal to see the difference diet can make on absorption. Such foundational research allows us to build further on the already solid framework of cannabis science.

In this trial Israeli medical cannabis patients are getting recruited to see cannabis's effect on the non-motor symptoms of Parkinson's. Another primary outcome measure will be to review changes in bladder overactivity. Other aspects to be reviewed include an analysis of different cultivars of cannabis.

The Beauty and the Limitations of Cannabis Studies

While controlling for methods of cannabis consumption and preexisting conditions are excellent starts, we're learning more about other variables which affect cannabis. For years now, Francesa Filbey has been working to prove that cannabis use, and cannabis use in tandem with nicotine, are separate categories. This year a team including her published data proving that those who use both cannabis and nicotine display different neural cannabis cue reactivity than the other groups. Earlier research by Filbey's team had concluded that while other groups worked so that a larger hippocampus correlated to better memory, the opposite was true for those who used both cannabis and nicotine.

Here we're learning more than ever through properly controlling our groups involved in the study, however, it does retroactively call some things into question. How can cannabis be studied without controlling the consumption of other substances? Considering what the research displays, it seems that many of the studies on cannabis already performed are compromised by insufficient separation.

 

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