As psychedelic-assisted therapy edges closer to mainstream medical acceptance, questions about legal and ethical access to these treatments remain unsolved.

A new paper, High Hopes: Legal and Ethical Issues with Post-Trial Access to Psychedelic Drugs, by Callie Terris, JD, MS, Clinical Ethics Fellow at UTMB Health, and Dr. Emma Tumilty, PhD, Assistant Professor and Director of Graduate Studies in the Institute for Bioethics and Health Humanities, tackles these pressing concerns.

Published in the Journal of Health Care Law and Policy, their research examines the risks faced by clinical trial participants post-study and offers harm reduction strategies for safer, more equitable access to psychedelic medicine.

The Dilemma of Post-Trial Access

With MDMA-assisted psychotherapy showing promise for PTSD treatment, clinical trials have revealed potential benefits. However, MDMA remains a Schedule I controlled substance, meaning that post-trial access is legally restricted.

Terris and Tumilty highlight the ethical responsibility of researchers and policymakers to address what happens after trials conclude, particularly for participants who experience symptom relief but have no legal pathway to continue treatment.

The study raises tough questions:

• Should trial participants be left without options if the treatment worked for them?
• What ethical obligations do researchers have to ensure continued care?
• And how can policy evolve to strike a balance between public health priorities and legal realities?

Aligning Science, Ethics, and Policy

These concerns extend beyond psychedelic medicine. Dr. Neil Mehta, PhD, MSc, MA, Associate Dean for Research at SPPH, points to lessons from history with other controlled substances, such as opioids and cannabis, where delayed or inconsistent policy responses have created public health challenges.

“This work addresses the ethical dilemmas of post-trial psychedelic access,” said Dr. Mehta. “It exemplifies SPPH's commitment to research that not only advances scientific understanding but also is directly pertinent to evolving health policies and regulatory frameworks.”

A Call for Thoughtful Reform

Rather than an all-or-nothing approach to psychedelic regulation, the study proposes harm reduction strategies, such as improved trial designs, expanded informed consent processes, and long-term support structures for trial participants. These steps, the authors argue, could reduce risks while allowing policymakers to work through the legal complexities of integrating psychedelics into clinical care.

As research continues to reshape our understanding of psychedelic medicine, this paper offers a much-needed perspective on the path forward.

To read the full paper, please visit the Journal of Health Care Law and Policy.

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