Past Is Prologue: Ethical Issues in Pediatric Psychedelics Research and Treatment

Summary

FDA has granted "breakthrough therapy" status for psilocybin and MDMA in adult psychiatry, prompting calls to expand psychedelic medicine to minors. However, a review of historical Psychedelics and Drug Studies from 1959 to 1974 reveals significant methodological and ethical flaws in early clinical psychology research involving children. The unique, ineffable nature of psychedelic experiences makes informed consent challenging for parents and psychotherapists. This prologue to responsible practice in medicine highlights risks like personality changes and trauma re-exposure. Strict eligibility, comprehensive psychiatric history, age-appropriate assent, and robust oversight are crucial for future studies.

Abstract

Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It provides ethics and policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children.

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