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28 J. Health Care L. & Pol'y 1 (2025)

handle is hein.journals/hclwpo28 and id is 1 raw text is: HIGH HOPES: LEGAL AND ETHICAL ISSUES WITH POST-TRIAL ACCESS TO PSYCHEDELIC DRUGS CALLIE TERRIS* EMMA TUMILTY** Abstract The United States is facing a mental health crisis. Yet, treatment options for complex conditions like Post-Traumatic Stress Disorder (PTSD') remain inadequate, inaccessible, or unaffordable for many. The urgent need for innovative therapies revived clinical investigations into the use of psychedelic drugs to treat mental health conditions. This Article explores the tension between methylenedioxymethamphetamine's (MDMA's) therapeutic potential for treating PTSD and the legal and ethical complexities of having access to a Schedule I controlled substance following the clinical trial. Given the widespread availability ofillicit and adulteratedMDMA outside the clinical trial setting and the risks associated with unregulated use, this Article argues proposed MDMA-assisted psychotherapy underscores the need to consider the long-term safety implications of unresolved symptoms in clinical trial participants. This Article concludes by offering preliminary recommendations on clinical trial design, the informed consent process, and long-term support structures to address the more pressing issues given current legal realities. 1 * Callie Terris, JD, MS, is a Clinical Ethics Fellow in the University of Texas Medical Branch Health System and in the Department of Bioethics and Health Humanities, University of Texas Medical Branch. ** Emma Tumilty, PhD, is an Assistant Professor & Director of Graduate Studies in the Department of Bioethics and Health Humanities at the University of Texas Medical Branch

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