June 22, 2023 by Alex Brewer, PharmD, MBA
TL;DR
- Psilocybin was classified as a Schedule I substance in 1970, with little (no?) credible supporting evidence for the move
- Research has challenged the notion that psilocybin “has no proven medical use” or “there is a lack of accepted safety…under medical supervision”, suggesting it should be rescheduled
- At the federal level, any rescheduling of psilocybin will likely be into a less stringent, but still regulated, schedule – meaning a federal endorsement or even decriminalization of recreational use is not likely any time soon
Psilocybin – the ingredient that puts the “magic” in “magic mushrooms” – has been consumed by humans for thousands of years. It was only with the passage of the Controlled Substance Act in 1970 that personal possession of psilocybin became fully illegal in the United States.
As of today, nothing has changed. Psilocybin remains classified as a Schedule I substance by the U.S. Drug Enforcement Administration (DEA).
Schedule 1?!
When we look at the DEA’s policy on substance abuse, a Schedule I substance is one which, in the eyes of the DEA, meets the following three criteria:
- The drug or other substance has a high potential for abuse.
- The drug or other substance has no currently accepted medical use in treatment in the United States.
- There is a lack of accepted safety for use of the drug or other substance under medical supervision.
Policy and science do not always see eye to eye – especially in the realm of controlled substances and “illicit drugs”. (See: the abysmal failures and horrifying consequences for individual liberty and medical research as a result of the War on Drugs and substance prohibition, but I digress.) Despite the Schedule I designation, psilocybin has been explored as a potential treatment for an assortment of conditions, particularly mental health conditions including depression, anxiety disorders, and substance use disorder.
About That…
A recent study published in Drug Science, Policy, and Law takes direct aim at dismantling the DEA’s position that “there is a lack of accepted safety for use of the drug or other substance under medical supervision”, with respect to psilocybin.
The study is a systematic review. A systematic review isn’t an “active” or “live” study. This type of study doesn’t involve scientists in lab coats administering medications and placebos. Instead, a systematic review tries to summarize data from many trials.
Confused? Think about it this way: you’re looking for a place to live. 101 Main Street is up for rent for $2,000 a month. It has 2 bedrooms, 2 baths, and lots of wonderful features. This is useful information, but what does it tell you about the rental market as a whole? Very little, if anything.
Which is why you don’t stop looking after finding just one place. You gather information about 10, 11, 12 places for rent. Now, not only can you compare each place, but you also have a more informed view of your rental options as a whole. Systematic reviews are similar – data is pooled from many trials so you have a more clear view of the whole picture.
In this study, the researchers analyzed data from 52 clinical trials. Of these 52 trials, 25 (48%) make zero mention of adverse effects or drug safety issues. In the other 27 trials, reported adverse effects were mild and went away on their own. Examples include headache, nausea, high blood pressure, and feeling anxious. This set of side effects puts psilocybin in a category with…caffeine, the most commonly consumed psychoactive substance in the world. I may be behind on current events, but I haven’t heard a chorus of politicians demanding a War on Caffeine to SAVE OUR CHILDREN.
A New Hope?
Moving forward, what does this mean? Researchers from Johns Hopkins recommend that psilocybin move from a Schedule I to Schedule IV substance, pending results from phase III clinical trials. This would move psilocybin out of the same schedule as heroin and bath salts, and instead would join other C-IV substances like alprazolam (Xanax) and zolpidem (Ambien).
Schedule IV substances still require a prescription, so don’t expect to see psilocybin appearing in corner shops (Amsterdam still has you covered there) or the local dispensary. Envision psilocybin administered by a qualified healthcare professional in a clinical setting – like a therapy session with a twist.
There’s still a way to go before we see psilocybin prescribed. But we have to count our wins along the journey. This study by Roscoe & Lozy adds to the growing swell of evidence showing psilocybin can be safely used, showing side effects are comparable to caffeine and other medications prescribed for mental health. It seems more a matter of “when” rather than “if” psilocybin is declassified as a Schedule I substance – a move that continues to look worse and worse with the passing of time. Here’s to hoping it offers a bit of magic to those living with mental health conditions.