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Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD

NCT02102802 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Not applicable
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD. The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity? Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in brain activity measured via fMRI while listening to trauma scripts

    Measured over Baseline, two months after final experimental session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405 Exclusion Criteria: * Mass brain lesion * Have metal in their skulls, * Having brain or heart pacemakers * History of major head trauma * Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)

Where

1 study site

FacilityCityRegionCountry
Offices of Michael MithoeferMt. PleasantSouth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02102802 on ClinicalTrials.gov →

Last updated in the registry 2024-11-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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