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CompletedN/A

Correlates of Anxiety Associated With a Life-threatening Illness

NCT02954562 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Not applicable
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this observational trial is to gather brain scan data on people undergoing MDMA-assisted therapy. The main question it aims to answer is: -How does brain activity change while completing an emotional regulation task in participants receiving MDMA-assisted therapy? Researchers will compare participants receiving MDMA-assisted therapy to participants receiving placebo plus therapy. Participants will undergo baseline brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task and other attentional tasks. Participants will then undergo two medication sessions of MDMA or placebo-assisted therapy. Then, undergo another brain scan. Participants will then undergo a third medication session and repeat the brain scans.

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

  • Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task

    Measured over Two months after enrollment in study NCT02427568)

  • Changes in fMRI Blood Oxygen Level Dependent (BOLD) resting state functional connectivity

    Measured over Two months after enrollment in study NCT02427568)

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, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)" Exclusion Criteria: * Have a brain mass or 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
University of California - BerkeleyBerkeleyCaliforniaUnited 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.

NCT02954562 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