Clinical psychedelic research in adolescents: a scoping review and overview of ethical considerations

Abstract

The potential use of psychedelic-assisted therapy for adolescents with mental illness has sparked both interest and concern. Modern psychedelic research has focused on adults, and adolescents younger than 18 years are typically excluded due to ethical and legal challenges. To explore whether adolescents have been included in 21st century psychedelic research, we conducted a scoping review of the medical literature from January, 2000, to April, 2025. Three trial registrations and one trial plan showed involvement of participants younger than 18 years, but none of these trials were completed and no trial findings have been published. The proposed studies would investigate 3,4-methylenedioxymethamphetamine (MDMA)-assisted or psilocybin-assisted psychotherapy as an intervention for adolescents with post-traumatic stress disorder, autism with social anxiety, or self-harm. Ethical approval and recruitment details were inconsistently reported. This scarcity of data highlights a major evidence gap that could hinder informed care. Given that many medications are used off-label in adolescents, we argue for cautious, ethically grounded research-starting with older adolescents with the highest foreseeable benefit-risk ratio due to special circumstances-to better understand the potential risks and benefits of psychedelic therapies for this vulnerable population.