Last reviewed · How we verify
NCT04438512: EAMP1
A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
trial testing Midomafetamine in Post Traumatic Stress Disorder. No longer available.
Quick facts
| Lead sponsor | Lykos Therapeutics |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Midomafetamine — full drug profile →
- Psychotherapy
Conditions studied
- Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
Sponsor
Lykos Therapeutics — full company profile →
Who can join
18 and older, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this expanded access protocol is to provide access to MDMA-assisted therapy for eligible patients with treatment-resistant PTSD who are not able to enroll in another MDMA-assisted therapy clinical trial. Participants will undergo three non-drug preparatory therapy sessions followed by three MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
Verify or expand the search:
- PubMed search for NCT04438512
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Midomafetamine
Trials testing the same drug.
- NCT04784143 — Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD · Phase 2 · terminated
- NCT04077437 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) · Phase 3 · completed
- NCT03282123 — Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD · Phase 2 · completed
- NCT03181763 — Evaluation of MDMA on Startle Response · Phase 1 · completed
- NCT01458327 — Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial · Phase 2 · completed
Other recruiting trials for Post Traumatic Stress Disorder
Currently open trials in the same condition.
- NCT07485231 — Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD · NA · recruiting
- NCT07316088 — Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms · Phase 2 · recruiting
- NCT07227337 — Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study · NA · recruiting
- NCT06988787 — Multifaceted Intervention to Restore Resilience and Overcome Risk · NA · recruiting
- NCT06740487 — Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder · NA · recruiting
Other Lykos Therapeutics trials
Trials by the same sponsor.
- NCT05147402 — Food Effects on Bioavailability of MDMA in Healthy Volunteers · Phase 1 · completed
- NCT04784143 — Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD · Phase 2 · terminated
- NCT04714359 — A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD · Phase 3 · completed
- NCT05066282 — Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD · completed
- NCT04077437 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04438512 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lykos Therapeutics
- Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04438512.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing