Correlates of Anxiety Associated With a Life-threatening Illness

Completed

Conditions studied: Anxiety

In brief

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.

Key facts

Study ID

NCT02954562

Run by

Resilient Pharmaceuticals

People needed

12

Starts

2015-11-07

Expected to finish

2017-09-30

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)"

You may not qualify if…

• 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 it is running

• University of California - Berkeley — Berkeley, California, United States

Full record on ClinicalTrials.gov

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