Psychedelic therapeutics in psychiatric conditions

Interest in psychedelic therapies is booming, yet no psychedelic treatment has been approved for any psychiatric condition. The one large-scale MDMA development program that reached the FDA was disapproved for reasons that could also apply to classical psychedelic trials. This review defines psychedelics, surveys current therapies, targeted conditions, compounds under investigation, and research strategies. Some interventions combine drugs with psychotherapy, bringing both benefits and challenges. Debate continues over whether the psychedelic experience itself is essential for therapeutic effect, complicating blinded trials. The review also addresses societal issues like deregulation of formerly illegal substances and regulatory hurdles, including alternatives to blinded trials and whether targets like adjustment disorder pose problems under current standards.

Study at a glance

Abstract

Interest in psychedelic therapies is booming, with hundreds of studies in process. Despite the interest, there are no approved psychedelic treatments for any psychiatric condition. Further, the one large-scale development program using MDMA that reached the FDA was disapproved by the agency for reasons that could apply to clinical trials for classical psychedelics. We review the definitions of psychedelics, the current status of psychedelic therapies, conditions targeted, compounds under investigation, and the research/clinical strategies employed. Some treatment interventions include pharmacologically assisted psychotherapy, with both benefits and challenges associated with this strategy. There is debate about whether the psychedelic experience is a required fundamental element for therapeutic potential with the induced psychedelic state, rendering blinded clinical trials challenging. We address current societal issues, such as the deregulation of formerly illegal substances in some areas, that may affect development decisions. Our review also considers regulatory issues, including alternatives to blinded trials and whether some therapeutic targets, such as adjustment disorder, may pose hurdles if current regulatory standards are applied to these trials. The interest in psychedelic treatment is considerable, although the path forward has some complexities.