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MDMA Therapy for Post-Traumatic Stress Disorder

CE
CP
Overseen ByCandace Parks
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunstone Medical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

MA

Manish Agarwal

Principal Investigator

Sunstone Medical, PC

Are You a Good Fit for This Trial?

Inclusion Criteria

I can complete all study assessments and attend all visits on my own.
Proficient in speaking and reading English
I am able to swallow pills.
See 1 more

Exclusion Criteria

I have a condition that makes it hard to eat or absorb food.
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
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
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • MDMA

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: IndividualExperimental Treatment1 Intervention
Group II: GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunstone Medical

Lead Sponsor

Trials
3
Recruited
110+

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