When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
This perspective article (2023) discusses the ethical considerations of providing post-trial access (PTA) in psychedelic clinical trials. It highlights the unique aspects of psychedelic trials, such as the legal status of psychedelics, the researcher-participant relationship, and the extended therapeutic process, as factors supporting the case for introducing PTA. The authors also advocate for a broader focus on post-trial care beyond access and provide an overview of potential provisions for psychedelic clinical trials, emphasizing the development of infrastructure for the post-legalisation psychedelic medicine ecosystem.
Authors
- David Nutt
- Meg Spriggs
- Ashleigh Murphy-Beiner
Published
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.
Research Summary of 'When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research'
Introduction
E. and colleagues situate their paper within ongoing debates in research ethics about post-trial access (PTA) to investigational treatments, noting the Declaration of Helsinki's 2013 call that sponsors, researchers, and host governments "make provisions for post-trial access for all participants who still need an intervention identified as beneficial during the study." They emphasise that although general frameworks acknowledge post-trial responsibilities, they are often vague about who should act, for how long, and under what criteria. The authors argue that contextual factors specific to psychedelic-assisted psychotherapy complicate these standard frameworks and strengthen the ethical case for routine post-trial provision in this field. The paper sets out three aims. First, to draw attention to ethical considerations particular to psychedelic medicines that support expanding post-trial provisions in clinical trials. Second, to begin identifying a range of post-trial care practices—broader than simple drug access—that could meet responsibilities towards participants. Third, to discuss how expanded post-trial care aligns with longer-term interests of the psychedelic research community and the development of an eventual clinical ecosystem for psychedelic medicine. The authors proceed by describing the modality of psychedelic-assisted therapy, presenting an illustrative case of a treatment-resistant participant who benefits but then relapses after a trial, and then highlighting three atypical features of psychedelic trials that together ground a strong ethical argument for post-trial care.
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- APA Citation
Jacobs, E., Murphy-Beiner, A., Rouiller, I., Nutt, D., & Spriggs, M. J. (2024). When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research. Neuroethics, 17(1). https://doi.org/10.1007/s12152-023-09536-z
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