The largest FDA-approved clinical trial of MDMA has shown promising results for the future use of the drug as a treatment for chronic PTSD. The results were the most pronounced one year after the experiment, when 76 percent of the participants no longer had the symptoms to qualify for a diagnosis of PTSD.
MDMA is a psychoactive drug that increases the activity of the neurotransmitters serotonin, dopamine, and noradrenaline in the brain. Commonly known as ecstasy, MDMA is primarily used as a recreational drug.
The research, which was sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), was a Phase 2 pilot study that was focused on 28 participants.
Brad Burge is the Director of Strategic Communications at MAPS.
“The only two medications approved for PTSD treatment are antidepressants (SSRIs),” said Burge. “Most patients need to take these drugs every day for many months, years, or sometimes forever in order to see their symptoms reduced.”
“Like any treatment, SSRIs approved for PTSD can have unwanted side effects, and since they are daily medications, many people struggle with them continuously. Other options for PTSD treatment can include various forms of therapy and yoga, which can be helpful for some patients but not all.”
PTSD is a mental health disorder that is triggered by a traumatic event and is characterized by panic and anxiety. The 28 patients involved in the trial were suffering from chronic PTSD that was related to events in the military, sexual assault, and other causes.
The participants were randomly assigned to three groups which all received 13.5 hours of normal psychotherapy in addition to three days of drug-assisted therapy. The patients were given either a full active dose of MDMA measuring 100 or 125 milligrams, or a low dose of 40 milligrams as a control.
“MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy,” said Burge. “The treatment involves only two or three administrations of MDMA in conjunction with psychotherapy in a controlled therapeutic setting, as part of a 12-week course of psychotherapy. In this program, MDMA is not the treatment by itself, but must be administered together with psychotherapy.”
The study revealed that, one month after the second experimental drug session, 42.9 percent of participants who had received an active dose of MDMA no longer met the criteria for a diagnosis of PTSD, compared with 33.3 percent in the control group. One year after the trial, 76 percent of the participants no longer had PTSD.
“Our study demonstrated that different therapy teams were able to get similarly robust results, further strengthening the case for MDMA-assisted psychotherapy as a promising option for the treatment of PTSD,” said study lead author Marcela Ot’alora.
“Plus, the results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma. After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.”
The study is published in The Journal of Psychopharmacology.