Recruiting at 1 site Phase 2 Post Traumatic Stress Disorder

Post Traumatic Stress Disorder study: MDMA

Official title MDMA Therapy in Veterans With PTSD

ClinicalTrials.gov ID: NCT07569159

What this study is testing

What is MDMA?

This is an investigational oral medicine being studied as a potential treatment for Post Traumatic Stress Disorder (PTSD). It is designed to affect brain chemicals to help with emotional processing during therapy sessions.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to find out if a 120 mg dose of MDMA, followed by a 60 mg dose, is safe and effective when used with therapy for PTSD.
Who it's for
The study is looking for adult veterans who have been diagnosed with Post Traumatic Stress Disorder (PTSD).
What's involved
Participants will take oral MDMA pills and attend therapy sessions, either individually or in a group.
Time commitment
The source text does not specify the total duration or the number of visits required.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Proficient in speaking and reading English.

You likely can't join if

  • 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...
  • Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically...
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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...
  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Rockville, Maryland, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Rockville, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.