Dave HodesEarly research indicates that psychedelics may play a key role in this arena.
Author: Dave Hodes
David Hodes is a business journalist based in the Washington D.C. metropolitan area. He has contributed feature articles to several cannabis and psychedelics publications, as well as general business/lifestyle publications, on a variety of topics. Hodes was selected as 2018 Journalist of the Year by Americans for Safe Access. He is a member of the National Press Club, and the deputy booking agent for the National Press Club Headliners Committee.
Recent Stories by Dave Hodes
Questions remain about how much to train and how much to pay trip-sitters.
Can psychedelics really treat the wide range of conditions being considered?
Most psychedelics clinical trials have some degree of failure in that there are people in the trial who simply can’t tolerate psychedelics as a therapeutic option—usually called adverse events. Common adverse events include headaches, nausea, vomiting, diarrhea, and anxiety. Researchers expect that there are more serious adverse events that go unreported.
Indeed, these adverse events have not been well studied, even as researchers focus on harm reduction during clinical trials in the hopes of bringing in larger groups of participants.
Future studies should describe the timing and severity of effects more extensively, one study concluded, adding that full transparency about adverse events is “a responsibility of clinicians, particularly in a nascent field fueled by the enthusiasm of pioneering researchers.”
One well-known adverse event is the so-called “flashback” from LSD use. But it is considered rare and occurs almost exclusively in the context of illicit recreational use in patients with anxiety disorders, and it typically will have a limited course of months to a year.
But exactly how a certain psychedelic affects any one patient is still a bit of a mystery, according to one study. “Larger studies need to validly define the benefits of using hallucinogens as an adjunct to psychotherapy and the patient characteristics that may predict such additional benefits of hallucinogens. Unclear are the aspects of the acute response to hallucinogens that best predict good long-term therapeutic outcomes.”
Outside of clinical trials, patient tolerance of psychedelics, and the benefit they get from psychedelic therapy, are issues that have been addressed numerous times, mostly with positive results, such as in the 2015 study published in the Journal of Psychopharmacology.
Using a data set of 135,095 randomly selected United States adults, including 19,299 psychedelic users, the associations between psychedelic use and mental health were studied, resulting in no significant associations between lifetime use of psychedelics and increased likelihood of past year serious psychological distress, mental health treatment, suicidal thoughts, suicidal plans and suicide attempt, depression and anxiety. “We failed to find evidence that psychedelic use is an independent risk factor for mental health problems,” the study concluded. “Psychedelics are not known to harm the brain or other body organs or to cause addiction or compulsive use; serious adverse events involving psychedelics are extremely rare. Overall, it is difficult to see how prohibition of psychedelics can be justified as a public health measure.”
Much of the newer science and research by psychedelics companies is aiming at identifying and controlling the hallucination effect from psychedelics in the hopes of scaling up psychedelics therapies to a broader demographic of people seeking mental and physical help.
For example, a genetically encoded biosensor to detect hallucinogenic compounds has been developed by researchers at the University of California, Davis, called the psychLight. Researchers can use psychLight to see how naturally occurring neuromodulators like serotonin, or hallucinogenic drugs, act on different parts of the brain.
Another approach gaining acceptance is to try carefully measuring a micro-dosage of the psychedelic treatment as a method of avoiding any profound hallucinogenic experiences—Algernon Pharmaceuticals’ (OTC: AGNPF) DMT treatment for stroke is one example.
A more recent discovery helps shed new light on who can use psychedelics and who cannot.
University of North Carolina School of Medicine researchers, led by Dr. Bryan Roth, MD, who also leads the National Institutes of Health Psychotropic Drug Screening Program, reported in a study in July that one reason for treatment disparity could be common genetic variations in one serotonin receptor.
Their study results indicated that some gene variations—even ones far from the exact location where the drug binds to the receptor—alter the way that the receptor interacts with the psychedelic drugs.
“Based on our study, we expect that patients with different genetic variations will react differently to psychedelic-assisted treatments,” Roth said. “We think physicians should consider the genetics of a patient’s serotonin receptors to identify which psychedelic compound is likely to be the most effective treatment in future clinical trials.”
The researchers worked with psilocybin, DMT, mescaline and LSD. The research was financed in part by The National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA).
“This is another piece of the puzzle we must know when deciding to prescribe any therapeutic with such dramatic effect aside from the therapeutic effect,” Roth said. “Further research will help us continue to find the best ways to help individual patients.”
Questions remain about the facilitator training programs.
Traditional tactics aren't always the most effective ways to raise capital.
Could synthetic psychedelics help pave the way?
There is psychedelics high fashion. Psychedelics perfume. A psychedelics series on Hulu featuring A-list actor Nicole Kidman. There are psilocybin microdose candies at weddings, replacing alcohol.
Psychedelics of all kinds are working their way into mainstream culture in California and elsewhere. The social elite – Mike Tyson, Miley Cyrus, even Prince Harry – are telling everyone that they’ve not only taken psychedelics, but that it’s changed their lives.
Business conferences about psychedelics are popping up everywhere, including what promises to be the granddaddy – 10,000 attendees in Denver in June for Psychedelic Science 2023 conference.
Johns Hopkins Medicine, NYU, Massachusetts General Hospital, MIT, some top California universities – all are studying psychedelics, some with millions of dollars invested in their work. There is even a new psychedelics caucus in Congress.
Psychedelics is back, big time, and here to stay. But is public attitude changing with the times?
According to a 2021 questionnaire given to 99 people about their attitudes on psychedelics and psilocybin therapy, the majority (72%) supported further research, with 59% supporting psilocybin as a medical treatment.
Younger age groups, those with previous psychedelic experience, and those with nonreligious beliefs were more likely to have favorable attitudes towards psilocybin. A total of 55% of the total sample would accept psychedelics as a treatment if a doctor recommended it.
It’s this sort of momentum for psychedelics that is driving the movement to decriminalize and legalize psychedelics across the U.S. There are now about 15 states or cities in states considering legislation or building working groups to decriminalize or legalize psychedelics. Colorado and Oregon legalized medical use of psychedelics, with Oregon’s legalized medical psilocybin program officially started this year.
There will be much more about the general public’s attitude on the practical use of psychedelics coming out of the Oregon program. But there is still a knowledge gap to overcome, even at the highest levels.
For example, in one study, researchers explored the acceptability of psychedelics among psychiatrists and found that, overall, psychiatrists perceived psychedelics as hazardous and “appropriately illegal.”
The data demonstrates misinformation about psychedelics and a lingering cultural stigma even among highly educated mental health professionals.
So are we still stuck with the stigma of psychedelics, sometimes coming from those respected authorities who we think should know better?
A report about psilocybin in the United Kingdom found that 59% of respondents would use psilocybin-assisted therapy if they had a condition for that kind of treatment. But 24% feared that they would get addicted to psilocybin.
Getting more and better information measuring the general public’s attitudes on psychedelics is fleeting at best. Too much is anecdotal, representing smaller groups or smaller subgroup demographics.
One group of researchers is attempting to develop a model for such measurement, reporting that in a rapidly developing research field such as psychedelics, it is important to understand how the general public views the topic, as well as any specific subgroup – professionals in the mental health field, policymakers or patients.
“Systematically assessing and measuring attitudes on psychedelics in a variety of settings and groups could help understand the wider context and implications of their medical use for psychiatry and society in general,” the researchers noted. “Any further developments in psychedelic research may also affect public opinion trends, which should be followed over time. A validated psychometric instrument allows for direct comparison and replication of data and is best suited to this purpose. Poor general knowledge on psychedelics is understandable, as psychedelic research has only recently experienced revival and the information on these topics is slowly reaching the mainstream.”
What they did find out is that a survey of college students’ attitudes on hallucinogens showed a majority thought that hallucinogens cause addiction. A significant number of participants thought that drugs such as heroin belong to the psychedelic group, indicating a poor understanding of psychedelics’ effects and the classification of illicit substances in general.
“Our findings of the association between knowledge and attitudes on psychedelics strongly indicate that assessing educational interventions is a logical next step,” the study concluded.
The U.S. federal government is perhaps the most difficult obstacle to overcome in changing the public’s perception, because the DEA’s Controlled Substances Act lists most psychedelics as being some of the worst substances on the planet. They are federally illegal, off limits, bad.
There’s a lot to learn still. A lot of misinformation to correct.
After the last 2-3 years of busy psychedelics business development, it feels like the psychedelics industry should be further along in helping the public understand where it’s coming from and where it’s going. The appears not to be the case.
Yet.
Yesterday, Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, released its financial results for the quarter ending November 30, 2022.
The company is one of the few in the industry reporting revenue growth, for the most part, because of its area of business concentration as a provider of therapy treatment services involving ketamine and Spravato.
Revenue grew 618% year-over-year to C$5.7 million. Their gross margin grew to 41.9% from 31.5% in the fourth quarter of 2022, with a gross profit of C$2.4 million, representing an increase of C$1.1 million.
The company ended the quarter with a cash position of C$26.4 million, down from C$41.8 in the previous quarter ending May, 2022, and also showed a net loss of C$6.2 million—C$1 million more than in 2021.
“We’re very pleased with the momentum that is building across all aspects of our business and the trajectory we’re on, making Numinus the first publicly traded psychedelic-focused company to achieve profitability, which we believe is likely to occur in the next 18 to 24 months,” Payton Nyquvest, founder and CEO of Numinus, said during the earnings call.
The company’s clinical network during Q1 2023 completed more than 19,774 client appointments, including one-on-one and group therapy sessions, neurology-related appointments, paid group programs, ketamine-assisted psychotherapy (KAT), transcranial magnetic stimulation (TMS) and ketamine/spravato medicine appointments, representing a 13.7 percent increase in clinic appointments compared to more than 17,000 appointments in Q4 2022.
Numinus had 138 practitioners providing client treatments through its wellness clinics and virtual services, a 13.1 percent increase from the beginning of the quarter.
The company was especially busy during the end of 2022, launching a new financing option for clinic patients in Canada and expanding its ketamine-assisted therapy offering to its Toronto location in September.
Then on October 28, 2022, Numinus announced the launch of its Ketamine for Chronic and Serious Medical Illness Program, a new program to be introduced in clinics in Utah, British Columbia and Quebec.
All this is seen as good news for the company by investors. The stock rose 13.64% on the Toronto exchange on the financial report news, though earnings per share were down slightly. Analysts positioned the company as a strong buy, according to Yahoo finance.
Future plans include establishing Numinus as a key provider of psychedelic-assisted therapy training during this quarter, Nyquvest said that they submitted a clinical trial application to Health Canada to conduct experiential psilocybin-assisted therapy training research. “This new experiential training study will enable practitioners training to provide psilocybin-assisted therapy the ability to experience and observe psilocybin sessions and further our understanding of the treatment,” he said. “It is one of the first training programs with an experiential option, and something that further differentiates our broader practitioner training program from others offered.”
Numinus is initially launching the program at their clinic in Vancouver but expects to expand it to other locations.
Nyquvest also noted that the company has focused on acquiring and adapting clinics that can meet the needs of psychedelic-assisted therapy protocols to be used in the future, ensuring their clinics have therapy rooms large enough to comfortably hold a patient and two therapists, with the appropriate soundproofing and patient access to private bathrooms. “Not all wellness clinic companies currently offering ketamine-assisted therapy have taken the same strategy, and we’re confident that Numinus is the best-positioned clinic network to offer MDMA or psilocybin-assisted therapies as soon as they’re approved.”
Nyquvest concluded his remarks by noting that the main focus is now around practitioner recruitment. “It’s about just filling the capacity that we’ve got as we get prepared for some of these other psychedelic products that we anticipate coming online early next year,” he said.
Modern psychiatry and research did not "discover" psychedelics for mental health.
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