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

"Declarations Competing InterestsDN reports advisory roles at COMPASS Pathways, Psyched Wellness, Neural Therapeutics, and Alvarius. EJ is funded by Wellcome Trust grant 221152/Z/20/Z. IR is co-founder and co-director of PsyPAN, and serves as an ACER integration sharing circle facilitator Competing Interests DN reports advisory roles at COMPASS Pathways, Psyched Wellness, Neural Therapeutics, and Alvarius. EJ is funded by Wellcome Trust grant 221152/Z/20/Z. IR is co-founder and co-director of PsyPAN, and serves as an ACER integration sharing circle facilitator"

"In the foregoing, we have argued that for psychedelic clinical research trials to act in a Helsinki Declaration-compliant manner, and in order to ensure robust standards of ethical practice, the field should seek to broaden the current practice of post-trial care. Precisely how the boundaries for appropriate post-trial support should be redrawn remains a matter for considerably more discussion: as with any shift from the status quo, such a move naturally raises questions about implementation, from ethical, practical, and resource-constraint perspectives. It may be that running a psychedelic trial for treatment-resistant depression incurs greater post-trial obligations towards participants than does a trial for tobacco cessation, and it may be that obligations towards a participant who has tried and failed to gain symptom relief from nine established treatments will differ in weight and shape to obligations towards a participant who had only tried two established treatments before trial participation. Further work is required to articulate what principles, or thresholds, might usefully be applied to translate the recognition of a duty towards (some) participants into implementable guidelines about quite how best to discharge that duty. Provision might sometimes be the sharing of harm reduction advice, sometimes the provision of long-term integrative counselling, and sometimes access to further psychedelic-assisted therapy sessions. Regrettably, interweaving practical realities – particularly guidelines governing research funding and national laws restricting the legitimate use of controlled drugs – present challenges to moving away from the status quo, culminating in a moral tragedy: despite the strength of the moral case for trial participants to be provided with extended care where needed following the conclusion of a psychedelic trial, there is no definitively compelling reason for any given actor to be responsible for discharging this obligation. There are considerable costs associated with the provisions we are endorsing, and these costs must be borne somewhere. We take the responsibility to be diffuse, requiring each of the actors called upon in the Declaration of Helsinki – researchers, research sponsors, and host governments – to work in concert for the advancement of practice, which will serve not just to better meet moral obligations towards trial participants today, but will also support the development of infrastructure and expertise needed for the psychedelic medicine ecosystem of tomorrow. Declarations: Competing InterestsDN reports advisory roles at COMPASS Pathways, Psyched Wellness, Neural Therapeutics, and Alvarius. EJ is funded by Wellcome Trust grant 221152/Z/20/Z. IR is co-founder and co-director of PsyPAN, and serves as an ACER integration sharing circle facilitator Competing Interests: DN reports advisory roles at COMPASS Pathways, Psyched Wellness, Neural Therapeutics, and Alvarius. EJ is funded by Wellcome Trust grant 221152/Z/20/Z. IR is co-founder and co-director of PsyPAN, and serves as an ACER integration sharing circle facilitator"