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S136: Exploring the Regulatory Framework and Ethical Considerations of Pediatric Psilocybin Research in US, Europe, and Canada

Poster Presenter

Leslie Cham

Student
Northeastern University
Canada

Objectives

The objective was to assess the regulatory and ethical considerations revolving pediatric psilocybin research in Canada, United States, and Europe as none currently exists.

Method

Psilocybin clinical trials were analyzed using clinicaltrails.gov and EudraCT database to determine potential future application in pediatrics. A review of the 3 countries current regulatory framework for psilocybin were conducted to determine the ethical and regulatory considerations in pediatrics.

Results

A review of the current regulatory framework amongst all 3 countries indicate psilocybin as a controlled substance with no approved therapeutic use. Psilocybin can only legally be obtained through new drug investigations, special programs, and exemptions. Clinicaltrials.gov resulted in 137 studies registered with psilocybin and EudraCT indicated 18 registered studies. The studies involved the investigation of psilocybin on a variety of mental health disorders to the characterization and understanding of psilocybin’s properties in healthy individuals. All studies registered are for adult participants that were indicated to be 18 years or older. There are no clinical trials currently approved for psilocybin’s use in the pediatric population. The indications in these studies are not exclusive to the adult population and are prevalent in the pediatric population. These clinical trials have the potential application for future use in the pediatric population. However, there are serious ethical considerations that must be considered due to the psychedelic properties of psilocybin in order for it to be prescribed or tested on children. These considerations include the informed consenting process involving children, the risk associated with alterations in mental state and self control, the training requirements for health professionals administering the drug, the unknown physiological effects of psilocybin on a developing child, and the safety and efficacy profile of psilocybin on the pediatric population. A review of the current regulations from Health Canada, FDA, and European Union indicates that they all adopted similar guidelines from ICH’s E11 Clinical Investigation of Medicinal Products in the Pediatric Population. However, these regulations are not fully harmonized amongst all 3 countries and do not fully anticipate the ethical considerations for this area. These regulatory and ethical considerations will need to be addressed before research in this area can occur.

Conclusion

A review of clinical trials from clinicatrials.gov and EudraCT illustrates a reemergence of research activity for psilocybin in recent years for a variety of indications including mental health disorders. However, all clinical trials currently being conducted are solely for the adult population. Yet many of the trials’ indications are relevant to the pediatric population. This is especially true for mental health disorders that can naturally develop at a young age and persist as one gets older. Thus, the potential application for psilocybin in the pediatric population is vast, but regulations surrounding its use in this vulnerable population are complex. Unlike other drugs, psilocybin is a psychedelic drug and classified as a controlled substance among the FDA, European Union, and Health Canada. Psilocybin’s properties as a psychedelic drug provides additional ethical challenges to consider when developing future regulations for psilocybin research in this population. These areas include informed consents involving children, training requirements for professional healthcare providers administering psilocybin, and the safety and efficacy profiles of this drug on the pediatric population. Although all three countries' regulation on clinical trials for pediatric population centers on ICH’s E11 guidelines, there are nuances between each regulatory agency that contributes to a lack of harmonization of policies in this area. In addition, the current regulatory framework initially relies on the extrapolation of data of clinical studies on adult trials. However, this type of data is never perfect and at times dangerous for the pediatric population. Thus, the future regulation and guidance will need to properly address the unique ethical considerations that are involved with psilocybin therapy if pediatric clinical research in this area is to ultimately occur.