Based on a new study of the safety and abuse potential of psilocybin, the hallucinogenic drug in magic mushrooms, Johns Hopkins University School of Medicine researchers recommend that "psilocybin should be re-categorized from a schedule I drug—one with no known medical potential—to a schedule IV drug such as prescription sleep aids, but with tighter control."
"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," says Matthew W. Johnson, 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 that take into account whether the drug has accepted medical use, and its safety and the potential for abuse. Schedule IV drugs are those that have a low potential for abuse or dependence.
Although preliminary research studies suggest that psilocybin may be effective for smoking cessation and for disorders such as cancer-specific depression and anxiety, it must clear phase III clinical trials before the Food and Drug Administration can be petitioned to reclassify it.
Highlights from their scientific paper published in the journal Neuropharmacology:
• Psilocybin mushrooms have been used for millennia for spiritual and medical purposes.
• Animal and human studies indicate low abuse and no physical dependence potential.
• Major national surveys indicate low rates of abuse, treatment-seeking and harm.
• Psilocybin may provide therapeutic benefits supporting its development as a new drug.
• Analysis supports the scheduling of psilocybin no more restrictively than Schedule IV.