Clinical psychedelic research has surged globally in the past decade, with dozens of trials investigating psilocybin and MDMA-assisted therapy for adults with mental illnesses including depression, PTSD, and addiction. The results in adults are, in some cases, promising. Yet, one group has been almost entirely excluded from this so-called ‘psychedelic renaissance’: adolescents under 18.
In a recent paper published in The Lancet Child & Adolescent Health, we conducted the first systematic review of psychedelic clinical trials that included participants under 18. Our team screened more than 1,600 records published or registered since 2000. We found only four studies worldwide that even proposed including adolescents under 18. None have been completed or published.
In other words: as of 2025, we have no clinical evidence about how psychedelic therapies might affect adolescents under 18.
This absence of evidence is not trivial. Many mental health conditions begin in adolescence, and some young people don’t respond to standard treatments. Some live with lifelong impairment, and some do not survive at all. If psychedelic therapies are approved as medications for adults, history suggests they will quickly find their way into adolescent care.
Clinicians regularly prescribe psychiatric medications to adolescents off-label without age-specific trials or published evidence, and psychedelic therapies could follow the same path. However, we also know that adolescents may face unique vulnerabilities: their brains and social realities are still developing, and they may be more prone to adverse experiences than adults. This raises a challenging ethical question: is it better to keep adolescents out of psychedelic research altogether, or to include them by gathering evidence under controlled conditions?
In our review, we advocate for the latter position, initially under cautious conditions with research on adolescents with the most to gain and the least to lose. Research should begin with older adolescents (16–17) facing exceptional circumstances, such as palliative care or severe treatment-resistant mental illness. Robust informed consent processes, family involvement, and safeguards against power imbalances between young patients and adult therapists are essential.
Some will argue that the potentially heightened risks of psychedelic therapy in adolescent contexts are too high, but risks must be weighed in context. Untreated mental illness beginning in adolescence carries devastating, sometimes fatal consequences. A 16-year-old with terminal cancer experiencing existential distress, or a 17-year-old with severe treatment-resistant obsessive-compulsive disorder, may be a no less of a suitable candidate for psychedelic therapy than their 18-year-old counterpart. Many adolescents can provide valid consent to participate in research, especially with parental support. Adolescents make decisions about treatments that have substantial short-term and long-term risks and benefits, such as in the case of cancer treatments or abortion. Yet, rigid age limits preclude adolescent minors by default, and do not correspond to individual care contexts. This kind of exclusion risks becoming a form of unjust discrimination.
Excluding adolescents from controlled research will not prevent adolescents from encountering psychedelic therapies, whether through unsupervised use or future off-label clinical access. However, it will limit our ability to better understand the benefits and harms of these therapies in practice, develop responsive therapeutic tools, and implement appropriate ethical safeguards for adolescent participants. In addition, adolescents already experiment with psychedelics outside of clinical settings, which can carry serious risks, but observational evidence in these settings remains scarce.
The absence of controlled evidence will also hinder informed decision-making by patients, clinicians, and families in the long run, as has been demonstrated in historical cases of drug research exclusion. For example, due to the widespread exclusion of pregnant people from drug research, we have limited specific evidence about risks, benefits, toxicity, dosing, and side effects in this group, placing those individuals who require making real-world decisions about medication at greater risk.
If psychedelic therapies are indeed part of the future of psychiatry, biomedicine, and mental healthcare, the question is not whether adolescents should ever be included in research, but how, when, under what conditions, and which adolescents (e.g., starting with those of older ages, greatest demonstrated consent capacity, most to potentially gain and least to lose)?
Adolescents deserve equitable access to the benefits of mental health research, which includes developing an ethically obtained, robust evidence base to accurately assess potential benefits and weigh risks in different contexts and subgroups.
As professionals working at the intersection of bioethics, clinical medicine, and adolescent mental healthcare, we have a responsibility to anticipate real-world benefits and risks of novel therapeutic tools, develop practical clinical knowledge and better understand if young people with unmet mental health needs could potentially benefit from therapies being tested in adults. At the same time, we must be alert to the possibility of distinctive risks and potential harms in this vulnerable population and ensure that any research that is conducted is rigorous and meets the highest ethical standards.
Khaleel Rajwani, MA is a PhD candidate and Canada Social Sciences and Humanities Research Council doctoral fellow in the Department of Philosophy at McGill University.
Brian Earp, PhD (@briandavidearp) is an associate professor of biomedical ethics at the Yong Loo Lin School of Medicine, National University of Singapore (NUS), and director of the Oxford-NUS Centre for Neuroethics and Society.