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

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.

Coming back together: a qualitative survey study of coping and support strategies used by people to cope with extended difficulties after the use of psychedelic drugs

“…It is commonly included as one of the three stages of psychedelic-assisted therapy – preparation, the drug experience, and integration – with most clinical trial treatment protocols including one or two sessions of integration after the drug session ( Thal et al, 2023 ). These treatment protocols typically do not anticipate and are not designed to treat problems that may emerge during or after a psychedelic experience ( Jacobs et al, 2023 ). Integration can involve short-term challenges ( Lutkajtis and Evans, 2023 ), and can be supported by connecting with a community that helps make sense of an experience ( Earleywine et al, 2022 ).…”