MDMA-assisted psychotherapy for post-traumatic stress disorder: The devil is in the detail

Abstract

Recent years have seen escalating media, public and scientific interest in psychedelic medicine. Australia and New Zealand have been late to this research; however, in the past 2 years, rapid developments suggest that this is changing. Here, we argue for the need to critically review existing evidence in this field to guide future directions. We focus on (±)3,4-methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, currently the most advanced area of clinical psychedelic research. Food and Drug Administration approval of this approach is likely in 2023, based on a series of promising findings. We provide a detailed overview of Phase 2 and 3 studies published to date. We identify several concerns related to this body of evidence, including methodological/design limitations and broader factors – such as robust involvement of advocacy groups in research and reliance on non-government financing leading to simplistic public messaging – that compound the methodological issues identified. We propose steps for future improvement, including the need for large, high-quality, independent efficacy trials with design enhancements, effectiveness trials and for researchers to consider their own engagement with media and public messaging around these modalities. We argue that, notwithstanding promising findings to date, rigorous and dispassionate science is needed to move the field forward and safeguard the welfare of participants.

Therapeutic frameworks in integration sessions in substance‐assisted psychotherapy: A systematised review

“…Thus, these proponents suggest the integration sessions follow a more structured, skill‐training‐based approach including didactic teaching, worksheets and metaphorical exercises typical of these therapies (Sloshower et al, 2020). The proponents of CBT and Mindfulness therapies further make the argument that these skill‐training‐based approaches are more clearly defined and more readily manualised and therefore are more scientifically rigorous (Bedi et al, 2022; Sloshower et al, 2020). While in contrast, they argue that the process‐oriented approaches lack specificity and therefore could also lead to reduced long‐term treatment efficacy (Watts & Luoma, 2020).…”

Psychedelic-assisted psychotherapy, patient vulnerability and abuses of power

“…Recent successes in Psy-AP research follow from decades of advocacy by a community strongly supporting this approach. Indeed, without advocacy, the ‘psychedelic renaissance’ would not have occurred (Bedi et al, 2023). Yet the robust involvement of advocacy groups protective of the ‘movement’ in Psy-AP research has clear potential to discourage and minimise reporting of negative clinical outcomes, ethical violations and abuse (see McNamee et al, 2023).…”

“…Yet the robust involvement of advocacy groups protective of the ‘movement’ in Psy-AP research has clear potential to discourage and minimise reporting of negative clinical outcomes, ethical violations and abuse (see McNamee et al, 2023). Whereas financial conflicts are now better managed in psychiatry, more nebulous conflicts – such as those arising when researchers are also strong advocates and members of the psychedelic community – are poorly accounted for (Bedi et al, 2023).…”

Psychedelics and treatment of mental disorders: A survey of attitudes and knowledge among psychiatrists, general practitioners and psychologists in Iceland

“…Aukinn áhugi og kerfisbundnar rannsóknir á notkun hugvíkkandi efna í meðferð geðraskana er nokkuð nýr af nálinni, og bent hefur verið á þaetti sem þurfi að baeta úr í rannsóknum þessu sviði, meðal annars til að auka áreiðanleika og réttmaeti niðurstaðna. [20][21][22][23][24][25][26][27][28] Einnig er margt sem enn á eftir að upplýsa, svo sem virkni efnanna í fjölbreyttari og staerri hópum sjúklinga, mismunandi tegundum og alvarleika sjúkdóma, mögulegar aukaverkanir og áhaettuþaetti ásamt hugsanlegum langtímaávinningi eða skaða af notkun þeirra. Háskólar og fagfélög munu gegna mikilvaegu hlutverki í að koma niðurstöðum rannsókna á þessu til skila til verðandi heilbrigðisstarfsfólks og þeirra sem tekið hafa til starfa.…”