There is great news for the nearly 5.2 million people in the United States that suffer from Post-Traumatic Stress Disorder (PTSD). The F00d and Drug Administration (FDA) has given their approval for 3-4 methylenedioxymethamphetamine (MDMA), better known as the street drug ecstasy, to be used in Phase 3 trials for the treatment of PTSD. The FDA gave the Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder.
The Phase 3 trials will be handled by the non-profit group Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS and the FDA have agreed on two upcoming Phase 3 trials under the Special Protocol Assessment Process to use MDMA in conjunction with traditional psychotherapy to treat severe PTSD. The combination uses three doses of MDMA as a pharmacological adjunct to assist traditional psychotherapy techniques.
When Will the Trials Begin?
The Breakthrough Therapy Designation indicates that the FDA has reviewed initial studies and agrees that this form of treatment may be better for some patients than traditional drugs.
The first Phase 3 trial is due to begin looking for candidates in September of 2018. The trial, called, “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,” will start shortly afterwards.
The study will look for 200 to 300 people with PTSD that are 18 and older in the United States, Canada, and Israel. Participants will receive three treatments with either MDMA or a placebo over the course of a 12-week treatment period. At the end, participants will undergo the Clinician Administered PTSD Scale test to determine how successful treatment has been.
How Successful Were Previous Trials?
The Phase 2 trials were completed with 107 participants, all of which had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of nearly 18 years. After the study, 61% of the people in the Phase 2 trial no longer had PTSD according to the scale test, and in a 12-month followup that number improved to 68 percent.
This is excellent news for people who suffer from PTSD, many of whom are combat veterans returning from the fields of Iraq, Afghanistan, and other war-torn countries. According to experts, between 11 and 20 percent of all soldiers who have served in those theatres are now suffering from PTSD.
The disorder expresses itself long after an initial trauma is witnessed or experienced. An attack of PTSD will often leave victims in a state of panic, unable to process what is happening and preventing them from dealing with the original incident. It’s this that makes overcoming PTSD difficult using just traditional psychotherapy. It can be difficult for people to talk about their experiences, especially because it is so traumatic.
Currently, only two prescription medications are used to treat PTSD: Zoloft and Paxil. Both are relatively ineffective with combat veterans, with a success rate of 33 percent or lower. Hopefully, with the use of MDMA during psychotherapy, sufferers from PTSD can process and move on from their individual traumas.
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