22 completed, 4 withdrawn, 3 terminated, 2 active not recruiting. 19 Phase 2, 7 Phase 1, 5 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder TREATMENT ARM: Full dose, CONTROL ARM: Active-controlled - PTSD, Post Traumatic Stress Disorder PTSD | Phase 2 | Not yet recruiting | U.S. Army Medical Research and Development Command | 86 | 2026-10-01 | 2026-07-15 |
| Study of Midomafetamine in Healthy Adults Midomafetamine HCl - Healthy Volunteers | Phase 1 | Active not recruiting | Resilient Pharmaceuticals | 32 | 2026-04-23 | 2026-06-29 |
| MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function Midomafetamine HCl - Pharmacokinetics, Hepatic Impairment | Phase 1 | Not yet recruiting | Resilient Pharmaceuticals | 16 | 2026-03-29 | 2024-10-30 |
| A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders Midomafetamine, Non-directive therapy, Therapy - Anorexia Nervosa Restricting Type, Binge-Eating Disorder | Phase 2 | Withdrawn | Resilient Pharmaceuticals | 2026-02-01 | 2024-10-31 | |
| Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2) Midomafetamine HCl, Therapy - Psychological Effects of Study Drug | Phase 1 | Withdrawn | Resilient Pharmaceuticals | 2024-12-01 | 2024-10-31 | |
| MDMA-assisted Massed Prolonged Exposure for PTSD 3,4 Methylenedioxymethamphetamine, Prolonged Exposure - Post-Traumatic Stress Disorder | Phase 3 | Active not recruiting | Healing Breakthrough | 20 | 2024-10-25 | 2026-08-26 |
| MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD 3,4-methylenedioxymethamphetamine (MDMA), Brief Cognitive Behavioral Conjoint Therapy (bCBCT) - PTSD, Relational Problems | Phase 3 | Completed | Dr. Leslie Morland | 16 | 2023-10-06 | 2025-12-08 |
| Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Midomafetamine, Therapy - PTSD | Phase 2 | Withdrawn | Resilient Pharmaceuticals | 2023-09-01 | 2024-10-30 | |
| Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD methylenedioxymethamphetamine - Post Traumatic Stress Disorder, MDMA ('Ecstasy') | Phase 2 | Recruiting | Guy Schusheim | 60 | 2023-06-01 | 2026-10-15 |
| Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD midomafetamine, Therapy - Posttraumatic Stress Disorder | Phase 2 | Withdrawn | Resilient Pharmaceuticals | 2022-08-01 | 2024-11-01 | |
| Food Effects on Bioavailability of MDMA in Healthy Volunteers midomafetamine - Pharmacokinetics | Phase 1 | Completed | Resilient Pharmaceuticals | 14 | 2022-07-28 | 2024-10-30 |
| Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD Midomafetamine, Psychotherapy - PTSD | Phase 2 | Terminated | Resilient Pharmaceuticals | 26 | 2021-11-08 | 2025-07-15 |
| Stanford Regulating Circuits of the Brain Study - MDMA MDMA - Healthy | Completed | Stanford University | 22 | 2021-11-02 | 2026-01-02 | |
| A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD Midomafetamine HCl - PTSD | Phase 3 | Completed | Resilient Pharmaceuticals | 87 | 2021-03-08 | 2025-06-06 |
| Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD PTSD | Completed | Resilient Pharmaceuticals | 186 | 2021-03-01 | 2024-10-30 | |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) Therapy, Midomafetamine, Placebo - Posttraumatic Stress Disorder | Phase 3 | Completed | Resilient Pharmaceuticals | 121 | 2020-09-02 | 2025-06-06 |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) Therapy, midomafetamine HCl, Placebo - Posttraumatic Stress Disorder | Phase 3 | Completed | Resilient Pharmaceuticals | 100 | 2018-11-21 | 2025-06-06 |
| Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) Midomafetamine HCl, Manualized therapy - Posttraumatic Stress Disorder | Phase 2 | Completed | Resilient Pharmaceuticals | 4 | 2018-03-13 | 2025-06-10 |
| Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD Midomafetamine, Manualized therapy - PTSD | Phase 2 | Completed | Resilient Pharmaceuticals | 38 | 2017-11-16 | 2025-06-05 |
| Evaluation of MDMA on Startle Response Placebo, Midomafetamine, Acoustic startle - Startle Response | Phase 1 | Completed | Resilient Pharmaceuticals | 34 | 2017-03-14 | 2025-03-04 |
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Stress Disorders, Post-Traumatic (24) · Anxiety Disorders (2) · Autistic Disorder (1) · Binge-Eating Disorder (1) · Combat Disorders (1) · Depression (1) · Emotional Regulation (1) · Mental Disorders (1) · Wounds and Injuries (1)
N-Methyl-3,4-methylenedioxyamphetamine (31) · Therapeutics (14) · Psychotherapy (5) · Lactose (2)
United States (24) · Israel (7) · Canada (5) · Switzerland (1)
Michael C Mithoefer, MD (4) · Michael Mithoefer, MD (2) · Moshe Kotler (2) · Adele Lafrance, PhD (1) · Barbara Rothbaum (1) · Bessel van der Kolk, MD (1) · Caroline Lewis, MD (1) · Casey Paleos, MD (1) · Charles S. Grob, MD (1) · Chris Stauffer, MD (1) · Cole Marta, MD (1) · Devon Christie, MD (1) · Emma Hapke, MD (1) · Ingrid Pacey, MBBS FRCP[C] (1) · Janel Long-Boyle, PharmD, PhD (1)
PMID 31065731, PMID 31572236, PMID 32500209, PMID 20643699, PMID 23118021, PMID 23172889, PMID 25818246, PMID 29728331, PMID 30196397, PMID 33235285, PMID 33972795, PMID 35166140, PMID 36405923, PMID 36713926, PMID 37709999, PMID 38174611, PMID 38198456, PMID 38994348, PMID 40305021
P50DA042012 (1)