FDA Approves Final Trial Before Ecstasy Can Be Used In Treating PTSD
Post Traumatic Stress Disorder is a psychological affliction which affects a lot of people and especially soldiers who went through some truly scarring experiences. And among these, only about 30 to 40 percent ever manage to recover, only after years upon years of counselling and medication.
However, illegal psychoactive drugs like psilocybin, aka magic mushrooms, or MDMA, aka Ecstasy, have been shown to have great results in treating people who suffer from psychological afflictions such as PTSD, addiction and depression. In recognising the situation, the FDA has approved the third and final test clinical trial, meant to establish the efficacy of ecstasy in the PTSD therapy. IF successful, the trial will allow the prescription of ecstasy by 2021.
This is by no means a new development. Since 1985, the Multidisciplinary Association for Psychedelic Studies, or MAPS, has supported the use of illicit substances like magic mushrooms, cannabis, LSD and ecstasy as a means in treating PTSD. MAPS has carried out its own research into the matter and has funded numerous clinical trials performed by other groups, including six Phase 2 studies treating a total of 130 PTSD patients with ecstasy. MAPS will also fund Phase 3 which should include 230 patients.
“Our overall Phase 2 study results have been extremely promising, having treated 107 subjects with chronic PTSD. 53% of 74 participants no longer qualified for PTSD after two to three MDMA-assisted psychotherapy sessions, compared to 23% who received placebo or comparator dose. Of 65 subjects interviewed one year after treatment, 66% no longer had PTSD,” reads a statement from MAPS.
Among the patients who participated in the trials were combat veterans, sexual assault victims, policemen and firefighters. Most of them did not respond to the traditional PTSD therapy and on average were struggling with it for more than 17 years. However, after only three doses of ecstasy the patients witnessed a 56 percent decrease in the severity of symptoms. Two-thirds no longer reported any effects of PTSD symptoms by the end of the study, effects which then lasted for more than a year following the trial.
“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” said Dr. Michael C. Mithoefer, the psychiatrist who conducted the trials in Charleston, South Carolina. “We think it works as a catalyst that speeds the natural healing process.”
These results have proven to be very promising and are the reason for why MAPS has applied the therapy for Trial 3. This procedure will speed up the process of approval and will make the therapy available by 2021. Besides PTSD, MAPS is also funding research that looks into the therapeutic value of MDMA for treating anxiety-related disorders.
“It’s a really interesting and a very powerful new approach,” Thomas Insel, a former director of the National Institute of Mental Health, told the San Francisco Chronicle. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”
Some doctors and physicians are more cautious, though. They believe that this new development will ignite a new wave of drug abuse among the populace. However, the thing is that ecstasy will only be issued and administered in the presence of an experienced therapist.
For many patients, MDMA is already life saver but, ultimately, the decision whether or not MDMA is deemed safe and effective in therapy is in the FDA’s hands.
“It gave me my life back, but it wasn’t a party drug,” said Edward Thompson, a 30-year-old former firefighter and alcoholic. “It was a lot of work.”