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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Individual
  • Drug: MDMA
    MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.
Experimental
Group
  • Drug: MDMA
    MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.

Recruiting Locations

Sunstone Therapies
Rockville, Maryland 20850

More Details

Status
Recruiting
Sponsor
Sunstone Medical

Study Contact

Clinical Evaluation Team
(301) 750-3401
clinical.specialists@sunstonetherapies.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.