Purpose of the Study
This multi-center study is designed to provide information on whether the drug MDMA combined with psychotherapy is safe and helpful for people with PTSD. Each volunteer will be assigned at random (like flipping a coin) to get either MDMA with psychotherapy or psychotherapy with a placebo. Volunteers will have a 50/50 chance of being assigned to either group.
Study Visit Overview
To ensure every study volunteer is safely evaluated in the trial, the study staff will meet with them to ask questions about their medical and psychiatric history. This is called screening. Potential volunteers will need to provide medical records, have blood drawn, and visit with a study cardiologist. If the volunteer is eligible for the study, they will meet with the study therapists for psychotherapy 15 times over about 4-5 months. There will be three day-long therapy sessions (with MDMA or placebo) and 12 other therapy sessions that are 1.5 hours long. Throughout the study, volunteers will complete questionnaires about how they are doing and meet throughout the study with qualified researchers over telemedicine (video) who will ask questions about their symptoms. At the end of the study, the study therapists and volunteer will meet one final time.
Phase of Research
MDMA-assisted psychotherapy for PTSD is currently in Phase 3 clinical trials in the US, Canada, and Israel. This means that previous studies have been completed that suggested MDMA-assisted psychotherapy is safe and effective for treating PTSD. The Phase 3 clinical trials will enroll more participants to determine if the previous study results were correct and collect more data on the risks and benefits of the drug.
Approximate Enrollment Dates
2020 – 2022
At least 100 people over 18 years old
How We Protect Your Privacy
Website questionnaire responses are encrypted and stored in a Health Insurance Portability and Accountability Act (HIPAA)-compliant database. In accordance with European General Data Protection Regulation (GDPR) policies, you can request to receive or delete your data at any time. Only the clinic staff that is selected to receive your information will have access to your responses.
To qualify you must
- Have PTSD (with symptoms lasting for at least 6 months)
- Be in good physical health
- Be at least 18 years old
- Be fluent in speaking and reading English (US/Canada) or Hebrew (Israel)
- Agree to be video recorded during visits with therapists
- Have a supportive relative, spouse, close friend or other caregiver to serve as your emergency contact
- Agree to all study rules and commit to all visits (which will be discussed during Screening)
- Not be pregnant, and commit to not getting pregnant during the study
- Not participate in any other interventional clinical trials during the duration of the study
- Be available for an 18-week period of time
- Be available for a full day one time per month for 3 months for all day therapy
- Be willing to remain overnight at the study site after each day-long therapy session and be driven home after