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

Brief description of study

This multi-center study is designed to provide information on whether the drug MDMA combined with psychotherapy is safe and helpful for people who have PTSD. MDMA is an experimental drug, which means that it has not been approved by the Food and Drug Administration (FDA) for sale for medical use in the United States (U.S.). MDMA is also a controlled drug and is sometimes known as “Ecstasy” or “Molly”. MDMA is a chemical that is structurally similar to some stimulant chemicals, like methamphetamine, which is both a major drug of abuse and an FDA-approved treatment for Attention Deficit Disorder, and to some psychedelic chemicals, like mescaline, which is found in peyote cactus. MDMA has already been used legally in research and illegally in uncontrolled environments, such as nightclubs. While much is known about MDMA and its risks, much remains unknown about this drug. This study will test the safety of MDMA-assisted psychotherapy as well as whether it works. During MDMA-assisted psychotherapy sessions, you will receive a dose of MDMA or placebo and possibly a second dose equal to half the size of the first dose about two hours later. You will have either the same dose or a slightly higher dose for the second and third sessions, which will happen roughly one month apart.

Clinical Study Identifier: s18-01354
ClinicalTrials.gov Identifier: NCTs18-01354