PMID- 37404971 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240306 IS - 1541-4094 (Print) IS - 1541-4108 (Electronic) IS - 1541-4094 (Linking) VI - 21 IP - 3 DP - 2023 Jul TI - MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. PG - 315-328 LID - 10.1176/appi.focus.23021011 [doi] AB - Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Appeared originally in Nat Med 2021; 27:1025-1033. CI - Copyright (c) 2023 by the American Psychiatric Association. FAU - Mitchell, Jennifer M AU - Mitchell JM AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Bogenschutz, Michael AU - Bogenschutz M AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Lilienstein, Alia AU - Lilienstein A AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Harrison, Charlotte AU - Harrison C AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Kleiman, Sarah AU - Kleiman S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Parker-Guilbert, Kelly AU - Parker-Guilbert K AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Ot'alora G, Marcela AU - Ot'alora G M AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Garas, Wael AU - Garas W AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Paleos, Casey AU - Paleos C AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Gorman, Ingmar AU - Gorman I AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Nicholas, Christopher AU - Nicholas C AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Mithoefer, Michael AU - Mithoefer M AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Carlin, Shannon AU - Carlin S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Poulter, Bruce AU - Poulter B AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Mithoefer, Ann AU - Mithoefer A AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Quevedo, Sylvestre AU - Quevedo S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Wells, Gregory AU - Wells G AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Klaire, Sukhpreet S AU - Klaire SS AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - van der Kolk, Bessel AU - van der Kolk B AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Tzarfaty, Keren AU - Tzarfaty K AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Amiaz, Revital AU - Amiaz R AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Worthy, Ray AU - Worthy R AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Shannon, Scott AU - Shannon S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Woolley, Joshua D AU - Woolley JD AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Marta, Cole AU - Marta C AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Gelfand, Yevgeniy AU - Gelfand Y AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Hapke, Emma AU - Hapke E AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Amar, Simon AU - Amar S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Wallach, Yair AU - Wallach Y AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Brown, Randall AU - Brown R AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Hamilton, Scott AU - Hamilton S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Wang, Julie B AU - Wang JB AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Coker, Allison AU - Coker A AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Matthews, Rebecca AU - Matthews R AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - de Boer, Alberdina AU - de Boer A AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Yazar-Klosinski, Berra AU - Yazar-Klosinski B AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Emerson, Amy AU - Emerson A AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. FAU - Doblin, Rick AU - Doblin R AD - Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail: jennifer.mitchell@ucsf.edu. LA - eng GR - R25 DA037756/DA/NIDA NIH HHS/United States PT - Journal Article DEP - 20230628 PL - United States TA - Focus (Am Psychiatr Publ) JT - Focus (American Psychiatric Publishing) JID - 101156081 PMC - PMC10316215 EDAT- 2023/07/05 13:05 MHDA- 2023/07/05 13:06 PMCR- 2024/07/01 CRDT- 2023/07/05 10:45 PHST- 2024/07/01 00:00 [pmc-release] PHST- 2023/07/05 13:06 [medline] PHST- 2023/07/05 13:05 [pubmed] PHST- 2023/07/05 10:45 [entrez] AID - FOC_23021011 [pii] AID - 10.1176/appi.focus.23021011 [doi] PST - ppublish SO - Focus (Am Psychiatr Publ). 2023 Jul;21(3):315-328. doi: 10.1176/appi.focus.23021011. Epub 2023 Jun 28.