MDMA Therapy in Veterans With PTSD
ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunstone Medical
About this trial
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.
Eligibility criteria
Qualifiers
Veterans who are at least 18 years old
Are able to swallow pills
Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Proficient in speaking and reading English.
Disqualifiers
Condition impairing oral intake or digestive absorption.
Unable to give adequate informed consent.
Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
Trial design
Treatments tested in this trial
- MDMA
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov