Most people might know MDMA for being a party drug which is commonly referred to as molly or ecstasy. Partygoers often take the drug to feel a euphoric high, but the drug has recently been used to treat patients who suffer from post-traumatic stress disorder. PTSD is a disorder that is caused by a traumatic experience in ones life such as war or sexual assault, which can cause flashbacks, feeling tense, angry outburst, trouble sleeping, and many other symptoms depending on the patient. Patients are given the drug under the supervision on a trained psychotherapist, which allows them to be able to discuss and look back on the experience that caused their disorder while feeling a layer of safety due to the MDMA’s affects. MDMA-assisted psychotherapy is for people who are not responding to traditional therapy for PTSD. In 2000 clinical studies of the drug was approved by The Food and Drug Administration, which is being carried out by the Multidisciplinary Association for Psychedelic Studies who also studies the benefit of drugs such as LSA, Ibogaine, Ayahuasca, Marijuana amongst other Psychedelic Research.
People affected by PTSD are overcome with fear when it comes to the event which lead to their disorder. This can be a problem in treatment as patients are encouraged to revisit the sometimes terrifying event to overcome the fear. This is where MDMA comes into play, by reducing fear levels, allowing the patient to revisit the traumatic event in a way that brings more to the surface benefiting there treatment.
The Null hypothesis of this study is that patients with PTSD, will have a positive affect on the patients side effects. While the reverse hypothesis is that patients with PTSD, will have a negative or no affect on the patients side effects. After only a few MDMA therapy sessions the patient should no longer need the assistance of the drug during treatment.
In 2004 phase 1 was approved to be ran by psychotherapists who had completed a research therapist training program through MAPS. There was one small catch, each psychotherapists had to have their own MDMA experience in the same setting which their patients would soon have the chance to. Rick Doblin, founder of MAPS found this to be a very important part of the study as he wanted the psychotherapists to better understand what their patients would experience throughout the process. As of now seven psychotherapists have completed the training and have found it was beneficial not only professionally but also on a personal level.
In 2015 a Phase 2 clinical study of the drug was approved by the FDA. This involves treating over 100 patients around the world to monitor exactly how safe and effective the drug is. The initial study included 20 subjects, which included some patients getting an inactive placebo with all the same therapy as those receiving the actual drug.(12 patients were given MDMA, while 8 were given placebos.) At the end of the study 25% of the patients who received the therapy and the placebo were free from PTSD. While 83% of the patients who received the therapy and the MDMA were now free from PTSD. The benefits of the treatment were reported to last an average of 3.8 years by patients. The rest of the studies are almost complete and should be published when MAPS applies for phase 3.
MAPS has hopes that by 2017 they can come to an agreement with the FDA to how Phase 3 will be conducted, from there they will have four years to finish the phase. These trials will contain around 400 patients costing around $21 million, more then half of the money has already been raised. MAPS current estimate is to have MDMA-assisted psychotherapy be legalized by 2021.
The sample size thus far has been small but this is due to how the FDA allows drugs to be tested. The study also faces the Drawer Problem as MAPS is the only group conducting studies to bring MDMA to the market. This is why the FDA is in control of what drugs are offered to the public. Up to this point in process the Null hypothesis has proven to be correct.
Source: Mithoefer et al. (2010)
Source: Mithoefer et al. (2012)