Expression of Concern: Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder

Expression of Concern: L. Ponte, L. Jerome, S. Hamilton, M. C. Mithoefer, B. B. Yazar-Klosinski, E. Vermetten, and A. A. Feduccia, “Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder,” Journal of Traumatic Stress 34, no. 4 (2021): 851–863. https://doi.org/10.1002/jts.22696.

This Expression of Concern is for the above article, published online on 10 June 2021, in Wiley Online Library (wileyonlinelibrary.com), and has been issued by agreement between the journal Editor-in-Chief Denise Sloan; International Society for Traumatic Stress Studies; and Wiley Periodicals LLC. The authors contacted the journal to request a correction to remove the data of 4 participants in the MP-4 study from the analyses included in this article. The authors notified the journal that during the MP-4 study (CT.gov identifier, NCT01958593), which took place between October 2014 through October 2016, there was an ethical violation resulting in a deviation from the protocol by a pair of therapists who treated 4 of 6 participants included in the MP-4 study. Neither of the two of the therapists involved were co-authors on the manuscript. Following receipt of this notice by the authors, Wiley and the journal opened an investigation into the reports of an ethical violation as well as the appropriateness of a correction.

The authors cooperated with the investigation and shared a report dated from October 2018 from Chesapeake IRB (now Advarra) to MAPS Public Benefit Corporation (now Lykos Therapeutics) as well as Advarra's follow-up report dated March 2022 regarding the ethical violation. The ethical violation was publicly announced in May 2019. The authors confirmed that they had not notified the journal regarding the ethical violation during the submission of their article in December 2019. As reported by the authors, at the time of submission the violation was stated to have happened after the completion of the treatment in the clinical trial and during the long-term follow-up. The authors also stated that they had included information from all study participants under the ITT principle. In March 2022 follow-up report, Advarra acknowledged additional findings that the protocol deviation and ethical violation had occurred during the trial as well as the long-term follow-up. The authors did not subsequently report this information to the journal until the completion of a compliance review by the College of Physicians and Surgeons of British Columbia and the finalization of a clinical study report by Lykos Therapeutics. The authors' initial contact with the journal occurred in early 2024 and further investigation indicated the significant level of complexity involved with making an accurate correction.

Following a review of the corrections to the data as well as the investigation regarding the ethical violation, the journal agrees that all data provided by those study therapists should be removed from the analyses included in this article via a correction [[https://doi.org/10.1002/jts.23098]]. However, the journal is also issuing this Expression of Concern because, while the author's conduct in not initially reporting the ethical violation to the journal has been judged as improper, the journal and publisher's investigation regarding violations of Wiley's and the journal's ethical guidelines regarding human subjects research has proven inconclusive. All authors agree with the expression of concern.