An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress Disorder - MDMA-Assisted Psychotherapy for the Treatment of PTSD

MAPS Europe B.V.0 sites8 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

December 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\. Are at least 18 years old
•2\. Are fluent in speaking and reading the predominantly used or recognized
•language of the study site
•3\. Are able to swallow pills
•4\. Agree to have study visits video\-recorded, including Experimental Sessions,
•Independent Rater assessments, and non\-drug psychotherapy sessions
•5\. Must provide a contact (relative, spouse, close friend or other support
•person) who is willing and able to be reached by the investigators in the event
•of a participant becoming suicidal or unreachable
•6\. Must agree to inform the investigators within 48 hours of any medical

•1\. Are not able to give adequate informed consent
•2\. Are currently engaged in compensation litigation whereby financial gain
•would be achieved from prolonged symptoms of PTSD or any other psychiatric
•3\. Are likely, in the investigator\*s opinion and via observation during the
•Preparatory Period, to be re\-exposed to their index trauma or other significant
•trauma, lack social support, or lack a stable living situation
•4\. Have used Ecstasy (material represented as containing MDMA) more than 10
•times within the last 10 years or at least once within 6 months of the first
•Experimental Session; or have previously participated in a MAPS\-sponsored MDMA
•clinical trial