No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Sunstone Medical · Other
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 Engli…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
* A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.
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