Suresh Muthukumaraswamy

Suresh is  a Professor in psychopharmacology at The University of Auckland. Suresh’s main research interests are in understanding how therapies alter brain function, mood and behaviour and has written extensively on clinical trial design in psychedelic science. Suresh began studying the psychedelics as postdoctoral fellow in 2011 with studies of psilocybin then later ketamine and LSD. He has received several Health Research Council of New Zealand research grants to support this work including grants to investigate the effects of microdoses of LSD and the antidepressant effects of ketamine. Suresh has published >140 papers, with his work receiving >10000 citations.

Psychedelics: Magic bullets or complex intervention?

Psychedelic-assisted therapy (PAT) has typically been evaluated using conventional randomized controlled trials (RCTs), which assess treatment efficacy under highly controlled conditions with the aim to show that the PAT causes improvements in outcomes. However, as previously pointed out extant RCTs PAT are best by many problems including but not limited to functional deblinding of both participants and practitioners, lack of consistency and contagion effects which limit causal inference. An alternate approach is to consider PAT as a complex intervention, integrating pharmacological, psychotherapeutic, and contextual elements that interact dynamically with patient experiences and healthcare settings. Conventional RCTs, designed for simple interventions, may fail to capture these complexities.

Established frameworks such as the UK Medical Research Council’s (MRC) framework for complex interventions may be more appropriate for the development and evaluation of PAT. This framework emphasizes the necessity of articulating the underlying theory of therapeutic change, structuring intervention development into defined phases, accounting for contextual interactions, and incorporating stakeholder perspectives throughout the research process. Complex interventions are best evaluated using pragmatic trials, which by contrast to typical RCTs, evaluate interventions under real-world conditions, assessing their effectiveness across diverse clinical environments and patient populations. It is argued that employing pragmatic trials, will better align PAT research with the practicalities of healthcare delivery and facilitate the translation of research findings into clinical practice.