Will the FDA be able to treat psilocybin in the near future?

Researchers at the Johns Hopkins University School of Medicine recently reviewed existing research on the safety and potential abuse of psilocybin, the active ingredient in hallucinogenic ("magic") mushrooms.

In their summary, published in the journal neuropharmacology, they suggested that if psilocybin canceled phase III clinical trials, the drug should be reclassified from a Schedule I drug (a drug with no known medical potential) to a Schedule IV drug (accepted for medical use with a lower potential for abuse). This would put him in the same category as prescription sleeping pills, but with tighter controls, according to the researchers.

"We want to start the debate now on how to classify psilocybin to facilitate its delivery to the clinic and minimize logistical hurdles in the future," said Matthew W. Johnson, Ph.D., associate professor of psychiatry. and Behavioral Sciences at the Johns Hopkins University School of Medicine. "We expect these final clearance trials to take place in the next five years or so."

According to the Controlled Substances Act of 1970, any drug that may be subject to drug addiction is classified according to criteria indicating whether the drug has been accepted as medical treatment and what levels of safety and abuse exist.

Although previous studies have suggested that psilocybin may be effective against smoking, depression, anxiety, eating disorders and even the pain of social rejection, it must be submitted to clinical trials phase III before being able to request the Food and Drug Administration (FDA) to reclassify it. .

Research in humans and in animals has shown that psilocybin has a low potential for abuse, the researchers said. For example, when rats have the opportunity to press a lever to receive psilocybin, they do not push it as they do for drugs such as cocaine, alcohol or heroin. Similarly, with respect to human studies, people who have used psilocybin report using it several times during their lifetime.

In terms of safety, research shows that it is often at the bottom of the scale and that users and society are the least affected, according to the researchers. Psilocybin also has the lowest risk of lethal overdose because there is no known level of overdose.

"We should be clear: psilocybin is not without risks, which are more important in recreational facilities than in medical facilities, but relatively, if we look at other drugs, both legal and illegal, 'proves to be the least harmful in different surveys and in different countries,' said Johnson.

However, researchers do not recommend leaving psilocybin in the hands of patients even with a prescription.

"We believe that the conditions must be strictly controlled and that, taken for a clinical reason, they should be administered in a health care facility supervised by a person trained in this situation," says Johnson.

According to the researchers, the process of using psilocybin in the clinic could be similar to the way an anesthesiologist prescribes and administers a drug, thus minimizing the risk of abuse or harm.

Source: Johns Hopkins Medicine

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