Will FDA OK Psilocybin Treatment in The Near Future?
Researchers at Johns Hopkins University School of Medicine recently reviewed existing research on the safety and abuse potential of psilocybin, the active compound in hallucinogenic (“magic”) mushrooms.
In their summary, published in the journal Neuropharmacology, they suggested that if psilocybin clears phase III clinical trials, the drug should be re-categorized from a schedule I drug (one with no known medical potential) to a schedule IV drug (accepted for medical use with lower potential for abuse). This would put it in the same category as prescription sleep aids but, the researchers say, with tighter controls.
“We want to initiate the conversation now as to how to classify psilocybin to facilitate its path 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.”
Following the Controlled Substances Act of 1970, any drug with the potential for abuse is categorized based on criteria showing whether the drug has accepted medical use and levels of safety and abuse.
Although previous studies have suggested that psilocybin may be effective for smoking cessation, depression, anxiety, eating disorders and even the pain of social rejection, it must clear phase III clinical trials before the Food and Drug Administration (FDA) can be petitioned to reclassify it.
Both human and animal research has shown that psilocybin has low potential for abuse, the researchers said. For example, when rats are given the opportunity to press a lever to receive psilocybin, they don’t keep pushing the lever like they do for drugs like cocaine, alcohol or heroin. Similarly, when it comes to human studies, people who have used psilocybin typically report using it a few times across their lifetime.
As for safety, research shows it frequently falls at the end of the scales with the least harm to users and society, say the researchers. Psilocybin also is lowest in the potential for lethal overdose as there is no known overdose level.
“We should be clear that psilocybin is not without risks of harm, which are greater in recreational than medical settings, but relatively speaking, looking at other drugs both legal and illegal, it comes off as being the least harmful in different surveys and across different countries,” Johnson said.
Still, the researchers don’t recommend releasing psilocybin into patients’ hands even with a prescription.
“We believe that the conditions should be tightly controlled and that when taken for a clinical reason, it should be administered in a health care setting monitored by a person trained for that situation,” says Johnson.
According to the researchers, the process for psilocybin use in the clinic might be similar to how an anesthesiologist prescribes and administers a drug, minimizing the potential for abuse or harm.
Source: Johns Hopkins Medicine
Pedersen, T. (2018). Will FDA OK Psilocybin Treatment in The Near Future?. Psych Central. Retrieved on August 12, 2020, from https://psychcentral.com/news/2018/10/01/will-fda-ok-psilocybin-treatment-in-the-near-future/139150.html