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.
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.
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.