MDMA It may be mostly known as an illicit party drug, but this psychoactive chemical seems to offer therapeutic applications far from the highlights of the rave scene.
In fact, MDMA therapy could soon become a legal and approved treatment for post-traumatic stress disorder (PTSD) in the United States.
In the first phase III clinical study for any psychedelic-assisted therapy, MDMA showed greater potential to help treat PTSD therapy than any other drug we have.
After only three sessions, patients treated with MDMA during treatment were 35 percent less likely to make a diagnosis of PTSD than patients treated with placebo.
During the two-month follow-up, 88 percent of the volunteers who received MDMA treatment had a clinically significant reduction in their symptoms – 28 percent higher than those who received placebo alone.
“MDMA is far from medically beneficial when combined with talk therapy in this protocol, has the potential to catalyze the therapeutic process and produce positive mental health outcomes.” he says Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS) in San Jose, California, which conducts exams.
MDMA is currently listed as Schedule 1 drug in the USA intended for substances without a legitimate medical purpose. Scientists have been trying to reverse this situation for years, and in 2017, after promising animal and clinical results, the FDA designated MDMA as “breakthrough therapy” for PTSD when used in conjunction with psychotherapy.
Researchers are still unsure how amphetamine works in therapy, but some speculate that it creates a “window of tolerance” where people can think about traumatic events without overcoming or experiencing dissociation.
Phase II clinical trials have already displayed The drug has promising effects and is safe to use in controlled doses under supervision. During the year, 67 percent of patients who underwent two or three sessions of MDMA treatment no longer showed signs of PTSD. Only 23 percent of the control group saw the same benefits.
Phase III clinical trials are usually larger and longer, but for a reason COVID-19, the sample size in the last experiment was slightly smaller than the scientists planned.
The study randomized 90 participants with severe and chronic PTSD into two double-blind groups. The first group received three MDMA therapy sessions, while the second group received placebo during the therapy sessions.
During the 18-week study, the researchers found “a significant and severe worsening of PTSD symptoms” as well as a relief of some depressive symptoms.
Even among people with the most difficult to treat PTSD, the new form of therapy seemed to help.
“MDMA is an experiential drug and therefore requires appropriate settings and settings that will actually lead to change and recovery.” he says neurologist Jennifer Mitchell of the University of California, San Francisco.
“While many forms of PTSD therapy involve a reminder of previous trauma, MDMA’s unique ability to evoke compassion and understanding in suppressing fear is probably what makes it so effective.”
The clinical study did not directly compare MDMA with current drugs used to treat PTSD, such as the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine, but these drugs are now known to work only in some people and usually come with less benefits.
In similar clinical studies, participants were treated with sertraline and placebo show effect sizes not greater than 0.37.
“In contrast, the magnitude of 0.91 demonstrated in this study between MDMA therapy and placebo-treated therapy was greater than any other previously identified pharmacotherapy of PTSD,” the authors write.
Further research is needed to directly compare current PTSD treatment with MDMA, but the authors hope that their results mean that MDMA will continue to be monitored rapidly for FDA approval.
The second half of a phase III clinical trial is currently underway, extending the research to another 50 patients. Volunteers from the first half of the study will continue to be monitored for long-term research.
“Compared to current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to dramatically transform PTSD treatment and should be rapidly evaluated for clinical use,” the authors conclude.
The team hopes for FDA approval as early as 2023.
The study was published in Nature.