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A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy.

Leor Roseman

Journal of Psychopharmacology April 1, 2025 DOI: 10.1177/02698811241309611 (opens in new tab)

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Characteristics Perspective or theoretical paper Case report Peer reviewed
Topics MDMA
Keywords Set and setting Psychedelics hallucinogens Entheogens Psychedelic medicine Paradigm shift transformation Revolution Fundamental change Psychopharmacology drug therapy Pharmaceutical psychiatry Medication science Mental health treatment
Citations 12
Key points Argues that the FDA's rejection of MDMA-assisted therapy reveals paradigmatic tensions in psychopharmacology between a biological model and one that sees drug effects as interactive with context.

Abstract

The recent rejection of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy by the U.S. Food and Drug Administration (FDA) is a dramatic moment in the re-emergence of psychedelic research. In this perspective, I argue that it represents a case study for paradigmatic tensions within psychopharmacology. The regulatory system is still influenced by a paradigm that sees the therapeutic effects of drugs as primarily biological, and context is noise to control for. An emergent paradigm considers the therapeutic effects of drugs as interactive with context. Psychedelics are the anomaly that questions the dominant paradigm, mainly due to the determination of psychedelic researchers that the medicines are drugs with psychotherapy. While some of the critique offered by the FDA towards MAPS/Lykos's studies is crucial, much of it is related to the experiential and psychotherapeutic elements - which the FDA claims not to regulate. This leads to some paradoxes within the regulatory procedure, which hint at a need for a shift in how psychedelic-assisted therapy is regulated and researched. Both regulators and researchers will need to find ways to accommodate each other in service of a successful integration of a new paradigm in which drugs and psychotherapy interact.

Comparable studies

Other theoretical and historical papers on MDMA, most cited first.

Study Year Design Participants
Differences Between the Mechanism of Action of MDMA, MBDB, and the Classic Hallucinogens. Identification of a New Therapeutic Class: Entactogens 1986 Theoretical or philosophical paper
The Background and Chemistry of MDMA 1986 Historical analysis
The origin of MDMA (ecstasy) revisited: the true story reconstructed from the original documents* Original documents in Merck's historical archive in Darmstadt, Germany, years 1900–1960 2006 Historical analysis
Distinct neural mechanisms for the prosocial and rewarding properties of MDMA 2019 Theoretical or philosophical paper
How could MDMA (ecstasy) help anxiety disorders? A neurobiological rationale 2009 Theoretical or philosophical paper

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Cites 13

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MDMA Psychedelic-assisted therapy