When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research

In psychedelic clinical trials, the case for providing patients with continued access to the investigational drug after the trial ends is especially strong due to the drugs' broader legal status, the unique therapist-participant relationship, and the extended therapeutic process. Because the therapy's effectiveness relies heavily on non-drug factors and the cultural setting, the authors argue for expanding post-trial care beyond just drug access. They outline potential provisions and contend that viewing post-trial care as an integral part of research—and a proper use of funding—will help build the infrastructure needed for a future psychedelic medicine system after legalization.

Study at a glance

Abstract

Abstract The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been subject to significant attention in the field of research ethics. Although no consensus has emerged, it seems clear that, in some trial contexts, various factors make PTA particularly appropriate. We outline the atypical aspects of psychedelic clinical trials that support the case for introducing the provision of PTA within research in this field, including the broader legal status of psychedelics, the nature of the researcher-therapist/participant relationship, and the extended time-frame of the full therapeutic process. As is increasingly understood, the efficacy of psychedelic-assisted psychotherapy is driven as much by extrapharmacological elements and the cultural therapeutic container as by the drug itself. As such, we also advocate for a refocusing of attention from post-trial access to a broader concept encompassing other elements of post-trial care. We provide an overview of some of the potential post-trial care provisions that may be appropriate in psychedelic clinical trials. Although the World Medical Association’s Declaration of Helsinki calls on researchers, sponsors, and governments to make provisions for post-trial access, such provision may feel impracticable or out-of-reach within psychedelic trials that are already constrained by a high resource demand and significant bureaucratic burden. We show how conceiving of post-trial provision as an integral site of the research process, and an appropriate destination for research funding, will serve to develop the infrastructure necessary for the post-legalisation psychedelic medicine ecosystem.