Phases of Study of Psychedelic Drugs and Current Findings

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Use of Psychedelics to Treat PTSD, OCD, Depression and Chronic Pain – a Researcher Discusses Recent Trials, Possible Risks

New research is exploring whether psychedelic drugs, taken under strict medical supervision, might help in treating post-traumatic stress disorder, chronic pain, depression and obsessive-compulsive disorder. Dr. Jennifer Mitchell – a professor in the Departments of Neurology and Psychiatry & Behavioral Science in the School of Medicine at the University of California, San Francisco was interviewed by SciLine. She discusses what scientists have found to date about the effectiveness of these drugs in treating these disorders and how best for them to be administered. Highlights and key excerpts of the interview have been transcribed and published below.

What are psychedelic drugs and how do they work?

Dr. Jennifer Mitchell: Psychedelic basically means “mind manifesting,” suggesting that the compound assists one in uncovering subject matter that perhaps is otherwise deeply hidden from the conscious mind.

It’s a slightly different term from hallucinogen, which you see used almost interchangeably at times with the term psychedelic.

A hallucinogen by definition is something that makes you see, hear, smell something that isn’t otherwise there, so you can imagine there’s a lot of overlap between psychedelics and hallucinogens.

Which types of psychedelic drugs are being studied by researchers for potential therapeutic use?

Dr. Jennifer Mitchell: The two most well studied drugs at this point are MDMA and psilocybin.

MDMA is being evaluated mainly for treatment of post-traumatic stress disorder treatments, and psilocybin mainly for treatment of resistant depression and major depressive disorder.

MDMA is the furthest along because there’s phase 3 data (data from late-stage research) and the possibility that a new drug application would be submitted to the FDA sometime later this year.

LSD is also being evaluated for a number of different indications, most notably obsessive-compulsive disorder.

And then a couple of sort of heavier hitters are now being tested in primarily healthy control populations, including drugs like mescaline and ayahuasca.

What have scientists discovered about whether these drugs are effective in treating health problems like PTSD or chronic pain?

Dr. Jennifer Mitchell: The drugs so far appear to be quite effective. I think one key, though, is that they’re typically being administered in conjunction with some form of psychotherapy.

So it’s important to keep that in mind when we look at the results from some of these recent trials that these are not drugs that are being administered in isolation. You are not taking home a bottle of pills and taking those twice a day as you would, say, an antidepressant. These are administered in a very particular way.

What is involved in therapeutic treatment using these drugs?

Dr. Jennifer Mitchell: Typically, prior to taking the drug at all, subjects participate in a number of preparatory sessions so that they understand a little bit about what is going to happen on an experimental session day.

And then subjects come into a room that looks very much like a comfortable living room, and they spend all day there. The drug is administered typically in the morning. For psilocybin, you’re looking at a six-hour dosing session, and for MDMA, an eight-hour dosing session.

You are in the company of a group of trained providers: therapists, psychedelic facilitators, psychiatrists and clinical research coordinators.

What are the potential risks of using psychedelic drugs for therapeutic purposes?

Dr. Jennifer Mitchell: One concern we’ve had is cardiovascular risk, and so we are taking great care in some of the clinical trials at present to evaluate cardiovascular burden, including heart attack risk, during and after the experiment. This evaluation includes tracking the heart rate and blood pressure of the participants.

In addition, researchers are worried about suicidality, in part because these are treatment-resistant populations that we’re starting off with, and so there’s a concern that perhaps, if they’re destabilized – either by the psychedelic, or just by tapering off their other meds in order to be part of a psychedelic trial – that we could run the risk of suicidality.

Lastly, I think the FDA has been concerned about the possibility that psychedelics are addictive, and so we’ve been following up with study participants to ensure that they aren’t engaging in drug seeking or drug taking outside of the study.

What do we know about the safety of taking psychedelics outside the clinical context?

Dr. Jennifer Mitchell: I think we’ve all heard stories from the ‘60s and ’70s of people taking psychedelics and having very bad experiences. What we know now is that the environment in which you take the psychedelic is of the utmost importance. It’s not appropriate at this point to try to take some of these substances or replicate some of these protocols on your own without oversight.

Watch the full interview to hear more about psychedelic medicine.

SciLine is a free service based at the nonprofit American Association for the Advancement of Science that helps journalists include scientific evidence and experts in their news stories.

Colorado Voted to Allow Psychedelics – What’s Next?

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After 50 Years in the Dark, There May Be a Light at the End of the Tunnel for Psychedelics

Last week, voters in Colorado chose to decriminalize psychedelic use for residents over the age of 21, becoming the second state in the nation to move towards acceptance of this burgeoning therapeutic treatment. The ballot measure also set the stage for state-regulated “healing centers” where medical professionals can administer psychedelic treatment as part of a therapeutic regimen. Psychedelics remain a Schedule 1 drug on the Federal level, but the FDA has recently given them a “breakthrough therapy” designation. So, what is next for these so-called magic mushrooms?

What the Vote Means

Decriminalization. This portion of the bill allows residents aged 21 and over to grow, posses, and share psychedelic substances (magic mushrooms) without committing a crime. Sale of the substances is still not allowed.

Supervised Use. The bill also allows state-regulated centers to administer psilocybin and psilocin treatments. These active compounds in psychedelics are being studied as a potential mental health breakthrough, used in-tandem with mental health therapy sessions, capable of treating various conditions, including depression, PTDS, anxiety, eating disorders, and substance abuse disorders.

Where Psychedelics Stand

From ‘A Quick Look at 8 Small Caps in the Growing Psychedelics Space’ – Published to Channelchek last December:

“In recent years, the Food and Drug Administration (FDA) has granted psychedelic compounds Breakthrough Therapy status, which has opened the door to new research studies and the potential development of new medications.  Recently, research and approval of new drugs has progressed past phase 2 trials for the use of psilocybin – the naturally occurring psychedelic prodrug compound produced by numerous fungi species – as treatment for depressive disorder. In another example, a drug proposed for the treatment of certain PTSD diagnoses is heading towards a second phase 3 trial, with full FDA approval possible as early as 2022.”

While full approval in 2022 didn’t happen, psychedelics continue to make headway in the FDA approval process. In July of this year, Filament Health (FLHLF) announced the beginning of dosing in the first FDA-approved clinical trial studying the effects of naturally derived psychedelic drug candidates. This study, designed to compare both the physiological and the psychological effects of psilocin, is expected to conclude towards the end of 2024.

While psychedelics and the FDA have a checkered past, the tide appears to be turning. A growing mental health crisis, along with years of research on the potential positive effects of psychedelic treatments, appear to be nudging the FDA closer to approval. Just last year, Johns Hopkins Medicine was awarded a National Institute of Health grant to stud psychedelic treatment for tobacco addiction. This federal research grant was the first of its kind approved in the past 50 years.

What’s Next

Schedule 1. Under the Controlled Substances Act, psychedelics remain in most restrictive Category 1, which creates numerous hurdles for approval as treatment. FDA approval would help. If current and future clinical trials lead the FDA to approve the drug for various treatments, the DEA would be prompted to reevaluate the drug’s schedule. Ballot initiatives like those in Oregon and Colorado also help on the local level.

Treatment. After more than 50 years, the study of psychedelics as part of a mental health treatment regimen is finally allowed. There’s a lot of lost time to make up for. Clinical trials will be needed for various conditions to determine appropriate dosing and combination therapies. Still deep in an opioid crisis, it’s fair to expect the FDA and DEA to proceed with caution, even with promising early results. 

Parallels. While completely different, it’s easy to draw certain parallels with the medical and recreational legalization of marijuana in the US. Over two decades, we’ve seen various states vote to legalize medical-only use, with others voting in favor of complete decriminalization along with legal recreational use, while a few states remain steadfast in keeping it a crime. Will we see similar results with psychedelics? It’s possible that, with the growing number of nearly untreatable conditions that psychedelics could improve, we see widespread medical acceptance in the coming years. Recreational use will almost certainly take longer with the current Schedule 1 status.

Acceptance and Capital. Acceptance is half the battle. The other is capital. The companies involved in bringing psychedelics to market will need investors backing them to move forward. Between clinical trials, therapeutic training, production, and marketing, these companies will need a great deal of funding to make it to market. But the potential is clear. Efficacy in early studies far surpasses any currently available treatment method for various mental health conditions, creating a market expected to grow to a value of over $3 billion by 2026.

Chris Patches
Channelchek Contributor

Sources

https://www.filament.health/news/filament-health-announces-first-dosing-in-groundbreaking-fda-approved-psilocin-clinical-trial

https://www.channelchek.com/news-channel/a_quick_look_at_8_small_caps_in_the_growing_psychedelics_space-2

https://www.pbs.org/newshour/nation/colorado-voters-approve-initiative-to-decriminalize-psychedelic-mushrooms

https://www.nbcnews.com/data-graphics/magic-mushrooms-psilocybin-map-colorado-us-states-rcna55980

https://clinicaltrials.gov/ct2/show/NCT05317689

https://www.hopkinsmedicine.org/psychiatry/research/psychedelics-research.html

https://www.amjmed.com/article/S0002-9343(21)00521-0/fulltext