A Phase 2 interventional study of MDMA in Post Traumatic Stress Disorder, sponsored by Sunstone Medical. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Sunstone Medical · Phase 2, Interventional, and Treatment
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.
This study's planned enrollment of 52 is below the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Sunstone Medical is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MDMA
Drug: MDMA
MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.
Safety and Tolerability
To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.
Time frame: 15 months
C-SSRS
Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) score at all visits from Baseline to EOS Visit.
Time frame: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5)
Time frame: 15 months
Effect of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS)
Time frame: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5)
Time frame: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI)
Time frame: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Quick Inventory of Depressive Symptomatology- Self-Report. ( QIDS-SR-16)
Time frame: 15 months
Effect of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the EQ-5D-5L.
Time frame: 15 months
Effects of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Clinician Administered PTSD Scale. (CAPS-5)
Time frame: 15 months
Plan to share: No
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Stress Disorders, Post-Traumatic→
Sunstone Medical