What a week it's been for the psychedelic world. Between new positive studies, new legalization and a new stock coming online investors must be, dare we say it, trippin'.
New Psilocybin Study
This week the JAMA Psychiatry published positive results from a clinical trial titled, "Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder." The question posed was "Is psilocybin-assisted therapy efficacious among patients with major depressive order?" It was a randomized trial of 24 patients who received the therapy, which was two sessions with supportive psychotherapy.
The study "documented a rapid decrease in mean (SD) depression score from baseline to day 1 after session 1 (16.7 [3.5] vs 6.3 [4.4]; Cohen d = 3.0; 95% CI, 1.9-4.0; P < .001), which remained statistically significantly reduced through the week 4 follow-up (6.0 [5.7]; Cohen d = 3.1; 95% CI, 1.9-4.2; P < .001). In the overall sample, 16 participants (67%) at week 1 and 17 (71%) at week 4 had a clinically significant response to the intervention (≥50% reduction in GRID-HAMD score), and 14 participants (58%) at week 1 and 13 participants (54%) at week 4 were in remission (≤7 GRID-HAMD score)."
In other words, the trial showed that psilocybin administered in the context of supportive psychotherapy of approximately 11 hours produced large, rapid, and sustained antidepressant effects. The study found that overall, suicidal ideation was low and trended lower after enrollment in both groups. The study reported that the effectiveness of psilocybin therapy after a single or only a few administrations represented a substantial advantage over commonly used antidepressants that require daily administration.
In Washington, DC, Initiative 81 secured enough votes from residents to pass. Initiative 81 needed to secure a simple majority to pass. The ballot initiative was originally proposed by Ward 6 resident and mother of two Melissa Lavasani and will, when implemented, reform police priorities to ensure that DC residents benefiting from plant and fungi medicines are not police targets. The plants and fungi covered by Initiative 81 include psilocybin mushrooms, ayahuasca, iboga, and mescaline-containing cacti, which can help those suffering from depression, anxiety, and addiction. Initiative 81 supporters collected more than 25,000 valid signatures from registered DC voters to place the measure on the November ballot.
Oregon became the first state in the country to legalize psilocybin as voters in the state passed Measure 109. Oregon Live reported that Measure 109 was passing by 56.12% Tuesday at 8:50 p.m. with 1,832,513 votes counted. While DC decriminalized it, Oregon will be the first to permit supervised use statewide if that majority holds. The product will have to be stored and administered at licensed facilities.
The measure, backed by chief petitioners wife-and-husband Sheri and Thomas Eckert of Beaverton, will allow regulated use of psychedelic mushrooms in a therapeutic setting. Measure 110, which also passed, will decriminalize possession of small amounts of drugs, including psychedelic mushrooms. Oregon Live also reported that Dr. Bronner's, known for its all-in-one soap and hemp products, had made large donations to Oregon's effort to legalize psilocybin.
Earlier in October, Field Trip Health Ltd. shares began trading on the Canadian Securities Exchange under the symbol FTRP ( (FTRPF) in the U.S.). This week the company said that that it is in advanced stages of identifying potential sites for Field Trip Health centers to treat people in Oregon with psilocybin therapies following the passage of Measure 109. Field Trip also opened a location in Chicago in October.
"Based on its geography and climate, Oregon is an ideal place for cultivation of psilocybin-producing mushrooms. But cultivation that meets all quality standards and analytical testing requirements is complex," said Marshall Tyler, Field Trip's Director of Research. "Our current cultivation research, which is focused on developing safety methods for microbial contamination, pesticides, mycotoxins, heavy metals, and analyzing tryptamine content from all psychoactive species at all stages of growth, positions us well to establish effective cultivation operations in Oregon and, subject to the regulations that are established, to be able to offer a wide variety of products and therapies to the people in Oregon."
The latest psychedelic newcomer Cybin Inc. has completed its reverse takeover (RTO) of Clarmin Explorations Inc. and plans to begin trading on November 10 on the Canadian Neo Exchange using the symbol CYBN. The reverse takeover will result in the original shares being delisted from the TSX Venture Exchange and the shares will be consolidated from 6.672 shares to one new Cybin common share.
The company said it hopes to obtain regulatory approval for one of the world's first approved psilocybin products targeting Major Depressive Disorder (MDD) - application filed for Phase 2a & Phase 2b clinical trial. The company also entered a feasibility agreement with IntelGenx Corp. (IGXT) for the development and production of the orally-dissolving film.
In addition to those efforts, Cybin has filed for a patent application for delivery mechanisms covering all psychedelic molecules delivered through oral films, transdermal patches, effervescent and oral dissolvable. Cybin is also working alongside the Canadian Centre For Psychedelic Science to determine the safety and efficacy of psilocybin-based microdosing - which could lead to a Cybin owned and funded clinical trial targeting anxiety, ADHD and overall cognitive flexibility.
The market is moving very quickly on psychedelics. While the market and patient population is quite different from cannabis, the promise for treating people is just as great. Epilepsy may have been the disease that pushed cannabis to be accepted by mainstream populations and it seems depression may be the condition that propels psychedelics to be accepted.