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A psychedelic research agenda? The quest for therapeutic and legal legitimacy

Muireann Quigley, Matt Hayler

Edward Elgar Publishing eBooks January 20, 2026 DOI: 10.4337/9781035325511.00020 (opens in new tab)

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Characteristics Theoretical or philosophical paper Peer reviewed
Key points Argues that although promising clinical results have fueled a 'psychedelic imaginary' of promissory visions around psychedelic therapies, the 2023 rejection by the United States medicines regulator of a New Drug Application for MDMA-assisted therapy for PTSD disrupted these expectations, and that legal and regulatory, methodological, ethical, and practical hurdles must be surmounted for the psychedelic promissory to become safe, effective, and desirable clinical realities.

Abstract

In this chapter, we consider the therapeutic potential of psychedelics, such as psilocybin and midomafetamine (MDMA), as a novel response to deepening mental health crises. In particular, we examine this in the context of restrictive drug control systems across Europe (including the United Kingdom). Whilst promising results from several clinical studies have fed into and helped to perpetuate a set of promissory visions and expectations, in 2023 the United States’ medicines regulator rejected a New Drug Application for an MDMA-assisted therapy (MDMA-AT) for PTSD. This has disrupted these visions and the psychedelic imaginary more widely. In light of this, we examine the ongoing quest for psychedelic therapeutic and legal legitimacy, arguing that a range of hurdles – legal and regulatory, methodological, ethical, and practical – need to be surmounted if the psychedelic promissory is to move beyond imagined futures into safe, effective, and desirable clinical realities.

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