When it comes to drugs like psilocybin and MDMA, culturally, our society is undergoing a major transformation as more trials on psychedelics come to light. In the relatively recent past, society thought that these compounds belonged to the world of addiction and degeneration. But now, they are increasingly seen as medicine.
This change in perception has gained strength in recent years. This is because the evidence for the healing effects of psychedelics has become more widely known. We go from whispered anecdotes about healing at illegal ayahuasca retreats to carefully collated clinical data measuring its efficacy in treating a range of mental illnesses. And although there are too many to cover in a single article, several recent essays have been so influential that they have accelerated our timeline for the legalization of psychedelics as medicine.
In this article, we cover 4 of the most influential medical psychedelic clinical trials of recent years.
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let’s remember what, for a new drug to be approved in the United States, it must go through several “phases” of clinical trials. First of all, in the phase 1, a drug must be shown to be safe for a small group of healthy humans. If successful, go to the phase 2. This measures the effectiveness of the drug in treating a specific disease in a larger population, although still small, of dozens of people. Often phase 2 is divided between the phases 2a and 2b: The first tests a series of dose levels, while the second tests a specific dose. Lastly, the step 3 tests the treatment on a larger group, often with more than 100 patients. If it is found to be more effective than current treatments in two separate phase 3 trials, the drug may be approved.
4 psychedelic trials that will change the game of medicine
MAPS Phase 3 Trial: MDMA Treatment of PTSD
In 2021, the Multidisciplinary Association for Psychedelic Studies (MAPS) public the details of your first test of phase 3, in which the Severe PTSD with MDMA therapy. The 90-patient study included war veterans and sexual assault survivors. On average, they had suffered from PTSD for 14.8 years. As this was the first phase 3 trial of a psychedelic drug, the stakes were high.
And they did not disappoint. In fact, their results were so positive that they appeared on the cover page the New York Timesushering in a new paradigm for psychedelic drugs.
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Two months after finishing treatment, of those who had received MDMA therapy, 88% still saw a reduction in their symptoms by at least 50%. And what is more impressive, 67% of those who received the treatment improved so much that “no longer met the diagnostic criteria for PTSD”.
Rick Doblinfounder and CEO of MAPS, believes this data is so positive that MDMA therapy to treat PTSD will be legalized as soon as 2023, after they complete their second phase 3 trial.
Awakn Life Sciences Phase 2 Trial: Treatment of Alcohol Use Disorder with Ketamine Therapy
Of all the psychedelics in this article, only ketamine is currently a legal drug in the United States. Primarily used as an anesthetic since the 1970s, clinics have opened across North America in recent years to use the psychedelic in therapy sessions, treating everything from depression to addiction. But despite its apparent popularity, clinical evidence of its effectiveness has been limited.
Until now.
In January 2022, You public the results of your phase 2 trial to treat alcohol use disorder in 96 patients. The company discovered that, 6 months after treatment, 86% of those treated with ketamine therapy remained alcohol-free, compared to only 2% who were already abstaining before starting the trial. What’s more, relapse rate was 2.7 times lower than that of those in the placebo group. In addition, the mortality rate in the year following treatment decreased by 90%.
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These figures are so positive that they represent a paradigm shift for what we consider possible in addiction treatment. For example, with current treatments, 75% of heavy drinkers return to their destructive habits within a year. Awakn’s trial is sure to fuel not only more research into ketamine-assisted therapy, but also accelerate the popularity of legal ketamine clinics around the world.
Compass Pathways Phase 2b Trial: Psilocybin Against Treatment-Resistant Depression
In late 2021, Compass Pathways released data from the largest psychedelic clinical trial in history. This phase 2b trial with 233 patients is trying to treat treatment resistant depression. This is a severe form of depression, in which the patient has previously tried at least two other forms of treatment, without success.
Perhaps the results of this test not be as revolutionary as the previous two examples. But they were very positive. It was found that, three weeks after finishing treatment, of those who received 25 mg of psilocybin combined with therapy, 36.7% saw a decrease in their symptoms by 50% or more; and 29.1% of these patients improved enough to go into remission.
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It is important to remember that the patients had a severe form of depression, and that other standard treatments had already failed. In this context, almost a third of participants going into remission is a significant achievement. However, in the future, Compass hopes to see better results in its phase 3 trials after improving its treatment regimen.
Hopefully, after improving his regimen, we’ll be able to see results more like other studies of psilocybin for depression. For example, the Compass-sponsored study of Open Labelwhich saw 80% of patients with major depressive disorder have a decrease in their symptoms of 50% or more, and 50% of patients went into remission.
Imperial College London Phase 2 Trial: Psilocybin versus SSRI for depression
Obviously, it is important that psychedelic drugs work well against a placebo in clinical trials. But it is arguably more pertinent to study how they work against current treatments. This is what the team of Dr. Robin Carhart Harris did in the Imperial College London, when compared the efficacy of psilocybin therapy in the treatment of major depressive disorder versus the most prevalent treatment option, SSRIs.
The phase 2 study aimed to investigate the reduction of depressive symptoms using the Qids-SR-16 scale. The researchers discovered that psilocybin was just as effective in treating depression as escitalopram, the SSRI used. In fact, the results of the psilocybin group were slightly better. However, the population was not large enough to say that there was a “significant difference” between the two compounds. The psilocybin group saw their depressive symptoms drop 8 points on the 27-point scale, while those in the SSRI group dropped 6 points.
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Looking at the secondary outcomes of this trial, the advantage of psilocybin over escitalopram became more apparent. For example, it was found that 6 weeks after treatment, 70% of participants in the psilocybin group saw their symptoms reduce by 50% or morecompared to 48% in the SSRI group. Furthermore, 58% of patients in the psilocybin group were considered to be in remission 6 weeks after finishing treatment, compared to 28% of patients in the SSRI group.
Those in the psilocybin group also “reported greater perceived improvements in the ability to cry and feel compassion, intense emotions, and pleasure, and reported feeling less sleepy than those in the escitalopram group.” This is important, as one criticism of SSRIs is that, although they may be effective in treating major depressive symptoms, they appear to do so by silencing emotions in general. Rather, psilocybin appears to make you deal with your emotions, and address the underlying causes of your depression.
Although this study was exciting, its small size of 59 patients limits what we can extrapolate from its data. Hopefully in the future we will see larger studies of psilocybin therapy versus SSRIs, so we can better compare their effects.
Via Psychedelic Spotlighttranslated by El Planteo.
Photo by Malcolm Lightbody via Unsplash