A Randomized Double-Blind Placebo-Controlled Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder | NYU Langone Health

A Randomized Double-Blind Placebo-Controlled Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Post-traumatic Stress Disorder
Age: Between 18 years - 150 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects are at least 18 years old
2. Subjects are fluent in speaking and reading the predominantly used or recognized language of the study site
3. Subjects are able to swallow pills
4. Subjects agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
5. Subjects 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. Subjects must agree to inform the investigators within 48 hours of any medical conditions and procedures
7. Female subjects of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session
8. Subjects agree to the following lifestyle modifications as described in the protocol

You may not be eligible for this study if the following are true:

1. Subjects are not able to give adequate informed consent
2. Subjects are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
3. Subjects 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. Subjects 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
5. Subjects have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation