In my most recent article, The Top 5 Psychedelic Milestones of 2022, I included three psychedelic clinical trials whose results will have reverberations for many years to come. In writing that article, however, I had the sense that I was leaving out many important psychedelic clinical trials that helped move the needle in the past year.
Therefore, in this article I will expand upon the last, and discuss three more ongoing psychedelic clinical trials that all readers should be aware of. Even this will not be a complete list, however, as 2022 saw dozens of interesting psychedelic clinical trials. To narrow down my selection, I decided to focus on trials hoping to answer unknown questions when it comes to psychedelics.
In The Top 5 Psychedelic Milestones of 2022, I included MAPS’ second Phase 3 trial, treating PTSD with MDMA-assisted therapy, MindMed’s (Nasdaq: MNMD, NEO: MMED) Phase 2 trial treating Anxiety Disorders with LSD, and Awakn’s (NEO: AWKN, OTCQB: AWKNF) Phase 2a/b trial using ketamine-assisted therapy to treat Alcohol Use Disorder. These will not make an appearance in this article, though I highly encourage you to check out The Top 5 Psychedelic Milestones of 2022 to learn more.
CYBN Moves the Needle on Next-Generation Psychedelics
In August, Cybin (NEO:CYBN, NYSE American:CYBN) announced that the first patients in its Phase 1/2a trial of CYB003 had been dosed. CYB003 is a next-generation psilocybin molecule that Cybin says has improved upon the original in several ways.
First, it is shorter acting. A regular full dose of psilocybin can cause psychedelic effects lasting north of six hours. Cybin says its preclinical data shows CYB003 cuts this in half. Cybin is attempting to treat Major Depressive Disorder in its Phase 1/2a trial of CYB003.
Next, Cybin says that CYB003 has less variability in effect between individuals, which would allow for more precision in choosing the proper dose. The time it takes for the drug to reach its peak after ingestion was also halved.
While we do not yet have any results from this trial, the preclinical animal trials have been impressive. If the results of the Phase 1/2a trial — particularly the 2a part — confirm the animal studies, then CYB003 could be a better alternative than traditional psilocybin.
This is because a monitored therapy session lasting most of the working day would be incredibly expensive, thus pricing out many who may be helped by the therapy. Therefore, a shorter session would be more affordable and accessible — though the jury is still out on whether a shorter guided psilocybin experience would provide the same mental health benefits as a longer one. The reduced variation in effect between individuals would also obviously be beneficial.
For more on this, see our Cybin 2022 end-of-year review
Small Pharma Launches World’s First DMT Phase 2 Trial
One of the most powerful — and mysterious — psychedelics is DMT. Of the classic psychedelics, it is also the most under-studied.
That is why, when Small Pharma (TSXV: DMT, OTCQB: DMTTF) launched the world’s first Phase 2a trial of the psychedelic this September, I personally was very excited.
Putting aside the perhaps more mystical questions of what is happening when a person “breaks through” and visits the “DMT realm,” there are many more practical — and answerable — questions regarding its potential use as a medicine.
As mentioned above, Phase 2 clinical trials — not to mention thousands of personal stories — have shown that psilocybin experiences can be effective for many people in treating mental health conditions such as depression and addiction. Its greater than six-hour duration of effect, however, can make it somewhat impractical as a medicine.
DMT is chemically similar to psilocybin, and it causes a similar — if much more intense — experience. The entirety of the psychedelic effects, however, last around 15 minutes.
The question then arises, could DMT-assisted therapy be as effective as psilocybin-assisted therapy? If it were, with its 15-minute duration, it would become the far more efficient, affordable and accessible medicine.
All of this is just conjecture at the moment, however, as we have yet to see clinical data suggesting this — though again there is a lot of anecdotal evidence. That is what makes Small Pharma’s Phase 2a DMT trial, attempting to treat Major Depressive Disorder so exciting. If they can confirm DMT is an effective medicine, it could become the most promising psychedelic being studied.
For more on Small Pharma, see our recent end-of-year review
Algernon Tests Whether DMT Can Treat Strokes
A big open question when it comes to psychedelics-as-medicines is whether their potential is limited to mental health conditions, or whether there may be physical health applications as well.
One company studying this question is Algernon Pharmaceuticals, (CSE: AGN, OTCQB: AGNPF), which is testing whether DMT can be an effective treatment for strokes.
In December, the company launched a Phase DMT 1 study. This, however, is just a warm-up for the first real test, their upcoming Phase 2a trial, which would follow a successful Phase 1 trial. As Phase 1 trials test for safety, and there is an abundance of evidence, including previous Phase 1 DMT studies, that the psychedelic is safe, the company is unlikely to face any problems in this trial.
In treating strokes, preclinical evidence has shown extremely encouraging results. Specifically, Algernon found that a low dose of DMT increased neuron growth by 40%. If this could be reproduced in a person who just had a stroke, their recovery could be much more effective.
If Algernon can prove that low doses of DMT can be an effective treatment for strokes, it would be revolutionary, as currently we do not have great treatment options.
Again, however, we will have to wait and see the results of the clinical trials before we get too excited.