Clinical Psychedelic Therapy Research Involving Adolescents: Protocol for a Scoping Review of Intervention Studies

Background: Recent years have seen renewed clinical interest in the therapeutic potential of classical psychedelics, such as psilocybin, LSD, DMT, and mescaline. While modern studies have focused on adult populations, adolescents under 18 are routinely excluded due to regulatory, legal, and ethical challenges. Although there exists observational data and historical studies from 1959 to 1974 focusing on persons under 18, these earlier trials do not meet contemporary scientific and ethical standards. Hence, despite growing interest in the intersection of adolescent mental health and psychedelic therapy, it is unclear whether any controlled clinical research has been conducted with adolescents in the 21st century. To address this gap, we intend to conduct a scoping review of clinical studies involving psychedelic drug administration, including psychedelic-assisted therapy, in adolescent populations. The present contribution is a protocol for this scoping review.

Methods: Our scoping review will adhere to the methodological framework of Arksey & O’Malley (2005), which involves five stages: (1) identifying the research question, (2) developing the search strategy, (3) setting inclusion criteria, (4) extracting data, and (5) presenting and analysing the results. We will include both peer-reviewed sources and study protocols that explicitly present evidence of an interventional study involving the administration of psychedelic drugs to adolescents under the age of 18 in the years 2000 - present. We will search for relevant studies in Pubmed (includes MEDLINE), EMBASE, APA PsycInfo, Cochrane Review Library, Web of Science, Cumulated Index to Nursing and Allied Health Literature (CINAHL) and Google Scholar. Clinical trial registers will also be searched, including the USA-based ClinicalTrials.gov and other global registers. Two raters will independently assess articles for eligibility, with disagreements to be resolved by a third reviewer. Data from eligible articles will be charted using a standardized data extraction form. The data will be reported following PRISMA-ScR guidelines.