MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study

Acknowledgements: The authors thank all of the participants who screened for and participated in this challenging research study, and acknowledge the oversight of the principal investigators, T. Nachsoni (Be’er Ya’akov, Israel) and N. Puri (University of British Columbia, Canada). The authors thank the study coordinators S. Sadler, K. Brown, C. Marsicano, M. Wimsatt, B. Bendixsen, D. Bissell, S. Serice, M. Gaffigan, C. Miller, R. Bacigalupi, B. Deyo, A. Baltes, T. Baron, L. Owens, S. Robison, D. Gumpel, C. Battistelli, A. Samkavitz, K. Blommaert, A. Menier, D. Katz, E. Pushkarski, N. Somech and M. Bar Haim for their work at their respective study sites. The authors are especially grateful to Charleston study coordinator S. Sadler, who passed away prior to the end of this study after a decade of work on this and several prior Multidisciplinary Association for Psychedelic Studies (MAPS) clinical trials. The authors also acknowledge the following study therapists for their skillful treatment of study participants: S. Braswell, W. Reynolds, C. Reusche, E. Passow, S. Gael Giron, D. May, J. Beachy, K. Cooper, A. Schnaitter, C. Hancock, C. Heacock, B. Balliett, E. Siegal, N. Brüss, V. Kraft, A. Booth, J. McCowan, S. Taylor, M. Skellie, Z. Hippel, M. Alavi, C. Stauffer, D. McDivitt, A. Rosati, K. Peoples, E. Sola, A. Penn, S.E. Sienknecht, G. Herzberg, H. Schwartz, V. Gold, J. Andries, C. Thomas, S. Ross, J. Guss, J.H. Duane, E. Nielson, K. O’Donnell, W. Hall, E. Nielson, P. Lister, E. Horowitz, A. Belser, J. Guss, J. Silverman, S. Walker, J. Hopper, M. Alpert, F. Guerriero, A. St. Goar, E. Call, C. Jackson, J. Simundic, H. Rubensohn, K. Lutz, S. Adams, T. Nachsoni, N. Halberstadt, D. Dogon, K.T. and I. Siemion. The authors thank the site physicians, nurses, research assistants, volunteers, night attendants, physical examiners and all site staff who contributed their time and effort to the study. The authors acknowledge the following select members of the MAPS PBC internal team who organized the study: M. Brown and G. Fortier, for their work in clinical trial management; A. Nary, P. Perl, E. Shainer, A. Pace and S. Ndukwe for careful monitoring of study data; A. Schwind, P. Llorach, M. Leighton, D. Iszak, S. Ramey-Wright and E. Gworek for tireless support of the study administration; S. Garcia-Velazquez for her review of participant safety data; J. Lindgren for coordination of IRB submissions; E. Heimler for dedicated effort in coordinating the independent rater pool; A. Wang, J. Lin and A. Garcia for overseeing the adherence rating and supervision programs; S. Scheld for supporting therapist and supervisor training and the development of the Code of Ethics; J. Poncini, C. Shelley, M. Tromba and A. O’Keefe for developing the technology and procedures to collect and manage session recordings with security and care; H. Clouting, B. Melton and K. Cohn for coordinating drug supply; A. Feduccia for her work on the phase 2 program that paved the way for this phase 3 trial; and C. Hennigan for the creation of the clinical databases. The authors also thank G. More for statistical programming, the teams of independent raters for their attention to detail and care for participants during outcome assessments, and the adherence raters for their close evaluation of the therapeutic delivery. No compensation was provided beyond normal compensation of employment. This clinical trial was sponsored by MAPS, a 501(c)(3) non-profit organization. MAPS provided the MDMA and fully funded this study from private donations. MAPS Public Benefit Corporation (MAPS PBC), wholly owned by MAPS, was the trial organizer. MAPS PBC provided the study design and the monitoring of study data; analysis, management and interpretation of data; reviewed and approved the paper; and submitted the paper for publication. The funder had no role in the collection of data or in conducting the study.