ShutterstockIn 2022, psychedelics such as MDMA, psilocybin and LSD are closer than ever to being legalized for medical purposes. While psychonauts have known about their potential to help mental health conditions such as depression, anxiety and trauma for generations, the medical establishment has been slow to recognize psychedelic drug potential.
But now that they have taken notice of these mind-altering substances they are…well, okay, they are still moving slowly. But, that is by design. In order for a new medicine to be approved for use in the United States, we need to be absolutely certain that it is both safe and effective. That takes time.
To ensure this, potential new medicines, including psychedelics, must pass through the clinical trial framework. In short, there are 3 phases a drug must succeed in, aptly named: Phase 1; Phase 2; and Phase 3. Phase 1 solely tests safety in a small group of around a dozen healthy people. Phase 2 tests the efficacy of the drug in treating a specific condition, such as depression, in several dozen people. Often, Phase 2 is split into Phase 2a and Phase 2b, where the first tests multiple different dose levels against each other to see which is most effective, and the latter uses just the dose determined to be best. Finally, if a compound has successfully passed both previous phases, it must complete Phase 3, where efficacy is again tested, but often in a larger group of around 100+ people. In order for the drug to be approved for use, it must complete two Phase 3 trials, with results showing that it is more effective or safer than current medications.
In this article, I aim to highlight the five most significant clinical trials that are either currently underway, or are set to begin in 2022. These trials will be make it or break it tests for whether MDMA, psilocybin, LSD, DMT and ketamine will ultimately be legalized for therapeutic use throughout the USA and the West more broadly.
Of all the trials listed here, MAPS’ is the furthest progressed. This trial, currently recruiting patients and set to begin this year, will be MAPS’ second Phase 3 clinical trial attempting to treat PTSD with MDMA-assisted therapy.
The first had phenomenal, paradigm shifting results. In it, 88% of patients with severe PTSD who received MDMA-assisted therapy saw their symptoms decrease by 50% or more. Even more impressive, a full 67% of patients who received the psychedelic “no longer met the diagnostic criteria for PTSD.” That sounds an awful lot like a cure for those people.
If MAPS can repeat these findings in a second Phase 3 trial, then MDMA-assisted therapy to treat PTSD will likely become legalized in the US. In fact, if you listen to Rick Doblin, Executive Director of MAPS, he expects MDMA-therapy for PTSD to be legalized before the end of 2023.
It is hard to believe that as slowly as the clinical trial process moves, it is possible that we could see the first psychedelic medicine become legalized next year. And yet, here we are. This makes MAPS’ second Phase 3 trial the most important psychedelic clinical trial of 2022.
Of all the potential medical uses of psychedelics, psilocybin for depression is the most well known. Despite this, current study so far has been mixed on just how effective the treatment is. For example, Johns Hopkins University found that the substance was four times more effective than SSRIs, the current most common depression treatment.
On the flip side, Compass Pathways’ Phase 2a trial treating Treatment-Resistant Depression has less positive results. The data, released in 2021, found that 3 weeks after treatment, 36.7% of patients who received 25 mg of psilocybin saw their symptoms decrease by 50% or more, while 29.1% improved enough to enter remission. While this was certainly positive, and more effective than the placebo, it wasn’t the game changing results that we had come to hope for. Though, it must also be stated that the Compass trial had a population of “Treatment-Resistant” individuals, meaning that everyone had attempted to treat their depression at least two other times without success. Or, in other words, they were attempting to treat the hardest cases.
Nevertheless, in 2022, Compass Pathways will begin the world’s first Phase 3 clinical trial using psilocybin. It will, once again, be attempting to treat Treatment-Resistant Depression. Hopefully, through modifying their regimen, Compass will be able to increase the effectiveness of the outcome. But, even if the results are similar, significantly helping one third of patients who could not find help elsewhere is still an accomplishment.
Either way, all eyes will be on Compass Pathways and their first Phase 3 trial in 2022.
When it comes to mental health, anxiety disorders can be particularly destructive. The panic they induce can cause disruptions in all arenas of a person’s life, including their family, work and social life. Plus, they are uncomfortably common. It is estimated that approximately 19% of American adults experienced an anxiety disorder in the last year, and 31% will experience an anxiety disorder in their lifetime.
Despite their prevalence, treatment options are limited. Mindmed hopes to change that, with a trippy solution: LSD therapy. Last year, MindMed completed a Phase 2a trial attempting to treat Generalized Anxiety Disorder with their version of LSD, called MM-120, though the public has yet to see the data. Now they are set to launch a Phase 2b trial this year. This is the furthest progressed clinical trial into LSD, for any indication.
Unlike psilocybin and MDMA, not many companies are currently doing research into LSD, and we have seen far fewer studies completed with the compound. This means that we can be less sure of its effectiveness, though anecdotally many profess the drug’s benefits. If the Phase 2b trial returns with positive results, it will be great news for those who struggle with chronic anxiety. It may also signal that LSD can be effective in other areas. Currently MindMed is testing the drug against many different indications, including: adult ADHD (in the form of microdoses); depression; cluster headaches; and chronic pain.
Unlike LSD and psilocybin, DMT is relatively short acting. Whereas the first two can last 6+ hours, the total DMT experience is around 20 minutes. Despite this, the experiences are similar — even if DMT is much more intense — as their molecules are similar in structure.
Since a core problem of psilocybin therapy is the drug’s long duration — having a therapist watch over a patient for 8 hours would be prohibitively expensive for many — the thesis for DMT is that if it delivers the same benefit as psilocybin therapy, but at a much cheaper price point, it would be the superior medicine.
Like with LSD, very little clinical research has been done into DMT. In fact, Small Pharma’s recently completed Phase 1 trial was the first-ever clinical trial with the drug. Despite this, like with LSD, there exists much anecdotal evidence that the drug can be beneficial. There are also non-controlled trials which show similar results.
Therefore, Small Pharma’s current Phase 2a trial, attempting to treat Major Depressive Disorder, should be watched closely. If its results indicate that the substance is equally as effective in a clinical setting as its cousin psilocybin, it will open a whole new avenue of research into psychedelics. This trial has already begun dosing patients, and we should expect data by the end of the first half of 2022.
Unlike the other four psychedelic compounds already mentioned, ketamine can already be used legally to treat mental health disorders. This is since it has been legal to use for decades as an anesthetic, and can be used “off-label” for other conditions.
Despite its legality, we still need to see incontrovertible evidence that it can be effective in treating the conditions that doctors are currently prescribing it for. Recently, Awakn released the results of a Phase 2 trial using the substance in conjunction with therapy, to treat Alcohol Use Disorder. The results were stellar.
Six months after treatment ended, 86% of patients remained abstinent from alcohol, relapse rates were 2.7 times lower than for the placebo, and those who received the ketamine therapy were 90% less likely to die in the following year.
Now, Awakn is progressing to a Phase 3 trial, though the start date is not yet known. If Awakn has similar results in its Phase 3 trial, then it will be the best evidence that we have to date that ketamine can effectively treat Alcohol Use Disorder.
Importantly, Awakn does not believe that ketamine’s anti-addictive effects are limited to alcohol. The company is also planning many studies treating various forms of addiction with the substance, ranging from gambling addiction, to Binge Eating disorder and even Internet Gaming Disorder.
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Interested in a psilocybin clinical trial for my son 49 y/o
One has to love how long it takes for the legalizing process along with the time consuming Phases. Oops my bad, my brain may have had a gaseous moment when recalling the Covid vaccines that was basically forced on everyone.
I suffer from anxiety and insomnia and I would like to participate in a clinical trial can somebody help me with some information please. My phone number is (323) 559-8899. Thank you
How does one apply for any of these studies in the US? Please provide a contact email and phone number! Thank you.
Hi I’m suffering from many years from anxiety disorder and depression I would like to partecipate on this trial, how can I do that ?
Unfortunately the situation is dire with my 31 year old son who has been suffering with depression and anxiety since childhood. He has not responded well to traditional therapy and drugs.
He would like to participate in a psilocybin research program.
Thank you,
Rachel Leah Belkin
Ridiculous, as the article says it’s been known for generations to have these anti-depressant (as well as very profound mystical effects I won’t go into). All of a sudden you need someone with 25 years of formal education and a measured dose to have the choice to use them??????? Preposterous.
They say “mushrooms are very promising but we don’t know how they work”. Firstly, irrelevant, secondly shaman do know, white people just don’t. Thirdly the only xplanation is this simple and is dictate by physically ca and brain scans.
The entire universe is made up entirely of atomic, subatomic particles and vibrations (different particles have different frequencies) these particles and vibrations actually require the brain…PERIOD, there is zero debate on these points!!!!!!!!
Personally I am an experienced guide and don’t give a full clean if the government tells me I don’t have the right but for those without access or who actually believe that proponderence of the evidence isn’t good enough, we must be Eurocentricly certain I feel it’s really unfair
I’m a middle-aged woman whom has sufferred with debilitating depression, anxiety, and PTSD for more than 30 years. I’ve participated in years of professional therapy and have been prescribed numerous psychotropic-type medications with only marginal benefit. Consequently, despite my commitment to wellness, I’ve grown quite discouraged and now feel ready to try something radically different – a medical trial utilizing psychedelics for the treatment of my mental health disorders. I would like to learn more about this possibility and would appreciate any information, regarding any upcoming studies in the general California area. Thank you.
Hi there,
I’m Anna. I recently discovered phychedelics and the positive effect they can have on those suffering with anxiety, depression etc. I’ve been reading, watching an researching and as someone who fights severe anxiety and depression I would love to be considered for a clinical trial. Thank you
Anna
I would like to enroll in a study using LSD. I want help with depression, chronic anxiety and the verbal abuse I grew up with.
My son age 30 has been suffering from depression, PTSD, ADHD, trauma, suicidal thoughts for a very long time. It’s debilitating.
We have tried counseling therapy and drugs. Nothing has helped him. I have read much on fungi and LSD, ketamine. Please if you have something/trial that might help. Studies have been the since the 50’s and 60’s but it was buried. Psychedelics
were made out to be an evil this thing. He can’t wait for the FDA.
I am so tired of waking up, taking medication for anxiety, depression and headaches. In the evening here I go again, medication to sleep, relief the anxiety and pray that I will not wake up with another cluster headache. I am more than willing to volunteer for a psychedelic trial. It would be a Miracle to throw away the pills. 513-370-9789
Cincinnati, Ohio
Good day
Is there any trials available in London UK
My son 44 has been self medicating on magic mushrooms and swears by it …he would like to be part of a trial and also an advocate to the fact that has helped him in so many ways to cope …
Hello, My name is Michelle I am 30 years old and suffer from Anxiety, depression and bipolar disorder. Please let me know if there are any upcoming trials.