What is a Schedule I substance?

According to the Controlled Substances Act, Schedule I substances have the following characteristics:

 

A) The drug or other substance has a high potential for abuse.

B) The drug or other substance has no currently accepted medical use in treatment in the United States.

C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

 

Other Schedule I substances include MDMA, heroin, and LSD (Controlled Substance Act, 1970).

 

Why is psilocybin classified as a Schedule I substance?

Good question! Despite ongoing research suggesting that psilocybin has psychopharmacological potential and is not harmful in clinical or research settings, it remains under Schedule I (Krebs and Johansen, 2013).  Also, there is a large body of evidence suggesting that psilocybin is not addictive . However, it can still be abused, and there is some evidence to suggest that they can lead to health consequences such as increased heart rate and nausea (National Institute of Drug Abuse, 2014). More importantly, unlike other drugs, the effects of hallucinogens are highly subjective and, therefore, variable. The National Institutes of Health holds the position that because of their unpredictable nature, the use of hallucinogens can be particularly dangerous (National Institute of Drug Abuse, 2o14).

 

Who controls the use of Schedule I substances?

Under the CSA, the FDA and the DEA both have roles in regulating controlled substances. The FDA is responsible for the scientific and medical evaluation of drugs. The DEA has a role in determining if a drug has potential for abuse and enforcing regulation. In order for research using psilocybin to be approved, the study must be approved by the FDA and the researchers must be licensed by the DEA to handle the drug (Ferro, 2013).

 

How long does it take for research study using a Schedule I substance to be approved?

 According to the DEA, it takes about 9 months to get FDA and DEA approval for a license to research Schedule I substances. However, researchers are more skeptical about that number and report that it often takes longer (Ferro, 2013)

 

CLICK HERE to learn more about the history of regulation on psilocybin and other psychedelics.