Journal of Psychopharmacology
April 29, 2015
Matthew J. Baggott, Matthew G. Kirkpatrick, Gillinder Bedi et al.
69 citations
MDMA increases the use of social, sexual, and emotional words during conversation. In a double-blind, within-subjects study, 35 healthy volunteers who had previously used MDMA received either 1.5 mg/kg oral MDMA or a placebo and then discussed a close personal relationship for five minutes. Both a standard dictionary method and a machine learning analysis showed that MDMA altered speech content: it boosted social and sexual words, and also increased words related to both positive and negative emotions. These changes in speech content may help explain how MDMA enhances sociability and emotional connection during social interactions.
Psychological Medicine
July 19, 2023
Tehseen Noorani, Gillinder Bedi, Suresh Muthukumaraswamy
49 citations
When a medical research program overlaps with a social movement, new forms of sociality—termed 'chemosociality'—emerge from shared chemical exposure. In psychedelic-assisted therapy (PAT) clinical trials, this chemosociality creates 'dark loops': unrecorded social interactions that breach assumptions underlying causal inference used to establish treatment efficacy. These loops affect participant experiences but are not incorporated into trial data interpretation. Three researcher responses are proposed: chemosocial minimization (designing trials to reduce dark loops), chemosocial description (openly documenting them), and chemosocial valorization (actively leveraging them for positive outcomes). The hype surrounding psychedelic research continues to shape the phenomena under study, even as trials grow larger and more rigorous.
Neuropsychopharmacology
April 23, 2024
Julia Colcott, Olivia Carter, Sally Meikle et al.
37 citations
A comprehensive systematic review and meta-analysis of 13 studies found that MDMA-assisted psychotherapy (MDMA-AP) is associated with increased odds of side effects compared to control conditions. In Phase 2 trials, MDMA-AP roughly doubled the odds of any side effect during medication sessions and in the following week. In Phase 3 trials, the odds of any adverse event during treatment were about 3.5 times higher with MDMA-AP than with placebo-assisted psychotherapy. Most side effects were transient and mild or moderate. However, the evidence had very low to moderate certainty, most trials had high risk of bias, and none adequately followed CONSORT Harms 2022 reporting guidelines, highlighting the need for further safety research.
Neuropsychopharmacology
January 24, 2020
Carla Agurto, Guillermo Cecchi, Raquel Norel et al.
33 citations
Computer-extracted speech features from acoustic, semantic, and psycholinguistic domains can detect mental states after controlled administration of MDMA and intranasal oxytocin. In a double-blind, placebo-controlled study with 31 healthy adults, speech tasks during peak drug effects yielded cross-validated accuracies up to 87% in the training/validation set and 92% in independent datasets for classifying drug conditions. Oxytocin-driven changes were mostly captured by acoustic features related to emotion and prosody, while MDMA-related mental states manifested across multiple speech domains. The experimental task—whether involving interaction with another individual—also affected speech responses. These results suggest speech analysis can provide objective markers of drug-induced mental states.
The Australian and New Zealand journal of psychiatry
April 1, 2023
Gillinder Bedi, Susan M Cotton, Alexandre A Guerin et al.
17 citations
Media, public, and scientific interest in psychedelic medicine has grown rapidly, and Australia and New Zealand are now catching up. This paper critically reviews existing evidence, focusing on MDMA-assisted psychotherapy for post-traumatic stress disorder, the most advanced area of clinical psychedelic research. The authors detail Phase 2 and 3 studies and identify methodological and design limitations, as well as broader issues such as advocacy-group involvement in research and reliance on non-government financing that lead to simplistic public messaging. They call for large, high-quality, independent efficacy trials with design enhancements, effectiveness trials, and careful researcher engagement with media and public messaging to ensure rigorous, dispassionate science and safeguard participant welfare.
Addiction
September 20, 2025
Elizabeth Knock, Krista J. Siefried, Gillinder Bedi et al.
4 citations
A single 25 mg dose of psilocybin combined with psychotherapy was safely delivered in an outpatient setting to 15 people seeking treatment for methamphetamine use disorder. No serious adverse events occurred; mild side effects included headache, nausea, and noise sensitivity. Methamphetamine use dropped from a median of 12 days in the prior month at screening to 0 days at 28 days and 2 days at 90 days after dosing. Craving decreased while quality of life, depression, anxiety, and stress scores improved at follow-ups. A larger randomized trial is needed to confirm efficacy.
Journal of affective disorders
July 17, 2025
Alene Sze Jing Yong, Sue E Brennan, Suzie Bratuskins et al.
3 citations
Australia's Therapeutic Goods Administration rescheduled MDMA in July 2023, permitting authorized prescribing for PTSD outside clinical trials. This manuscript describes development of an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD using the GRADE process. The guideline will compare benefits and harms of MDMA-assisted psychotherapy against other treatments, drawing on high-quality systematic reviews. A multidisciplinary Guideline Development Group will consider evidence certainty, patient values, resources, equity, acceptability, and feasibility. The guideline will be published on MAGICapp and disseminated through peer-reviewed publications and conferences. A Companion Guide will be created for people with PTSD and their carers.
BJPsych Open
November 1, 2025
Jonathon Marinis, Sarah Clarke, Alexandre A. Guerin et al.
2 citations
Side-effects reporting in clinical trials of psilocybin-assisted psychotherapy (PAP) for psychiatric conditions is inconsistent but improving over time. A systematic review of 24 trials published between 2005 and 2024 found that only six had high-quality side-effects reporting, while nine were low and five were very low. All nine randomized controlled trials showed high risk of bias for side-effects outcomes. There was no evidence of systematic underreporting in published articles compared with trial registers, but variability in reporting hindered comparisons. The authors conclude that existing evidence has a high risk of bias and that future trials should follow best-practice guidelines, and discussions with patients should emphasize current uncertainty about PAP side-effects.
BMJ open
February 10, 2025
Kathryn Fletcher, Nadine Ezard, Krista J Siefried et al.
1 citation
A pilot study will test the safety and feasibility of combining subanaesthetic ketamine with cognitive behavioural therapy for adults with methamphetamine use disorder. Twenty participants seeking to reduce or stop methamphetamine use will receive three subcutaneous ketamine doses (0.75 to 0.9 mg/kg) at weekly intervals and four therapy sessions over four weeks. The study will measure recruitment time, eligibility rates, treatment completion, retention, and acceptability over eight weeks, and explore changes in methamphetamine use, cravings, withdrawal, quality of life, and treatment satisfaction over 24 weeks. No pharmacological treatments currently exist for this condition, and psychotherapy alone is only moderately effective.
BMJ open
May 11, 2026
Julia Colcott, Alexandre A Guerin, Olivia Carter et al.
A new tool, the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET), was developed to systematically capture side effects during MDMA-assisted psychotherapy. Experts in MDMA-AP and neuropsychopharmacology participated in a two-round online Delphi process to refine a list of 165 items across four questionnaires covering screening, baseline, medication session days, and follow-up. The tool aims to improve safety monitoring and build a more robust evidence base on the tolerability of MDMA-AP for research and clinical use.
Journal of affective disorders
February 2, 2026
Alene Sze Jing Yong, Aimée Freeburn, Suzie Bratuskins et al.
Australia became the first country to allow authorized prescribing of MDMA for PTSD outside clinical trials. Interviews with 21 clinicians, researchers, and patients who had direct experience with MDMA-assisted psychotherapy or PTSD revealed eleven themes, including the importance of expectation management, comprehensive baseline screening, shared decision-making, flexible treatment protocols, ongoing consent, strong therapeutic alliance, and post-treatment continuity of care. The findings emphasize the need for safeguards, provider training, and integration of care as MDMA-assisted psychotherapy enters clinical practice.
medRxiv
February 21, 2025
Alene Sze Jing Yong, Sue Brennan, Suzie Bratuskins et al.
preprint
Australia's Therapeutic Goods Administration rescheduled MDMA in July 2023, allowing its prescription for PTSD outside clinical trials. This manuscript outlines the development of an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD, using the GRADE process to weigh benefits and harms against other treatments. A multidisciplinary Guideline Development Group, supported by stakeholder and expert groups, will consider evidence certainty, patient values, resources, equity, acceptability, and feasibility. The guideline will be published on MAGICapp and in peer-reviewed outlets, with a companion guide for people with PTSD and their carers.
May 17, 2024
Jonathon Marinis, Sarah Clarke, Gillinder Bedi
preprint
The authors argue that existing evidence on adverse effects of psilocybin-assisted psychotherapy is undermined by methodological problems, such as small sample sizes, lack of standardized reporting, and inadequate control conditions. They call for more rigorous research to accurately assess risks before clinical adoption.