Researchers have been studying the use of MDMA, also known as Ecstasy, as a potential treatment for post-traumatic stress disorder (PTSD). However, three papers on MDMA-assisted therapy were recently retracted by the journal Psychopharmacology due to what was described as unethical conduct at one of the study sites.
The papers’ authors are connected to Lykos Therapeutics, the company whose application for MDMA-assisted therapy was rejected by the Food and Drug Administration (FDA) last week. The FDA cited concerns about missing data and issues with the study design in their decision. Despite this setback, Lykos has stated that they plan to appeal the FDA’s decision and conduct an additional clinical trial.
The retracted papers were initially reported by Stat, a health and medical news website. In response to the retraction, Lykos expressed disagreement with Psychopharmacology’s decision and stated that they would file a complaint with the Committee on Publication Ethics.
The incident that led to the retraction involved a therapist who engaged in a sexual relationship with a participant in the study after the dosing sessions had concluded. This breach of professional conduct highlighted the challenges associated with psychedelic medicine, which can make patients especially vulnerable during treatment sessions. Most clinical trials involving psychedelic compounds require the presence of two mental health professionals for this reason.
The Multidisciplinary Association for Psychedelic Studies (MAPS) conducted the research on MDMA therapy and later formed Lykos to market the treatment. The association publicly acknowledged the incident in 2019 and reported it to the FDA and Canadian health authorities.
Lykos admitted that they failed to inform Psychopharmacology about the violations but believed that a correction, rather than a retraction, was the appropriate response. The company remains committed to advancing research on potential treatments for PTSD despite the recent setbacks.
Overall, the retraction of the papers raises questions about the ethical conduct of research in the field of psychedelic medicine and underscores the importance of upholding professional standards in clinical trials. As the debate continues, it is essential for researchers and companies involved in this emerging field to prioritize patient safety and adhere to ethical guidelines to ensure the credibility and integrity of their work.
