MDMA-Assisted Psychotherapy Clinical Trials
The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and educational organization working as a clinical trial sponsor to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD). MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with all federal regulations including the Drug Enforcement Administration (DEA). MAPS obtains Certificates of Confidentiality for clinical trials which protect against involuntary disclosure of the identities of research subjects participating in MAPS clinical trials.
Information about PTSD and the Research
Posttraumatic Stress Disorder (PTSD)
PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds. People with PTSD may find it difficult to keep a job and maintain healthy relationships. Many people with PTSD have depression or suicidal thoughts. Some have difficulty managing their relationship to drugs and alcohol. PTSD can cause nightmares, flashbacks, difficulty sleeping, and bursts of anger. Symptoms can last a long time and significantly affect quality of life.
Science Behind the Study
Why are we using MDMA-assisted psychotherapy to treat PTSD?
Initial studies suggest that MDMA used in combination with psychotherapy may help people who have PTSD. Though we do not know exactly why it may help people with PTSD, we know that MDMA may increase positive mood and changes the way we see and think about the world around us, making it easier to think about and recall things that happened to us that are upsetting. People say they feel caring and forgiving toward themselves and others during the MDMA experience. It is possible that these drug effects, when combined with psychotherapy, help people work through thoughts, memories and emotions related to traumas and other past experiences.
How this Research Could Help with PTSD and What We Can Accomplish Together
Volunteers in this study will help us understand better if MDMA-assisted psychotherapy works for PTSD. We cannot guarantee that volunteers will benefit from participating in the study. Volunteers will be provided the all study activities (including over 40 hours of therapy) at no cost to them. All people who participate in clinical research are contributing to scientific knowledge and might help researchers and doctors find better treatments for PTSD.