The FDA has listed MDMA as a breakthrough therapy in post-traumatic stress disorder, and validated the protocol for a phase III clinical trial.
MDMA, a future remedy for post-traumatic stress? In the United States, research on this psychoactive substance which notably composes ecstasy is progressing. Because out of the context of parties and clubs, “3,4-Methylenedioxymethamphetamine” gives very promising results for treating anxiety disorders such as PTSD (post-traumatic stress disorder). So much so that the FDA, the American drug agency, changed the status of this treatment to classify it among the list of therapeutic breakthroughs (” breakthrough therapies’).
This list identifies the molecules on which preliminary work has shown significant efficacy compared to other existing therapies and gives hope for very promising results.
Changing the status of MDMA represents an important step: it leads to the acceleration of the procedure and the provision of treatment. It also confirms the effectiveness of MDMA, a psychoactive substance strongly stigmatized because of its illegal nature, as well as the validity of the protocols implemented in the previous trials.
Available in 2021
The Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit scientific organization that has been researching and lobbying for MDMA therapeutics, has announced an agreement with the FDA on a phase III clinical trial. “If it demonstrates its effectiveness, the drug could be available as a legally prescribed treatment for patients with PTSD as early as 2021”, writes MAPS in a communicated.
In the years 1970-1980, after the rediscovery of the molecule by the psycho-pharmarcologist Alexander Shulgin, networks of researchers and doctors used MDMA unofficially to treat certain mental disorders, recalls MAPS. With a precaution: ensure that the molecule does not leave the medical environment to spread in a festive context, as was the case with LSD. At the time, the therapeutic results were very promising.
But, like LSD, MDMA ended up falling into the hands of the general public who used it recreationally. Authorities banned the consumption and possession of MDMA in 1985, much to the chagrin of these therapists. Many have been fighting since to reintroduce it into the therapeutic arsenal.
Effective on heavy symptoms
Phase II trials have been carried out across the world. They show that 68% of subjects with PTDS no longer show symptoms one year after the treatment administered for 12 weeks. The subjects were selected for their specific profile: suffering from chronic post-traumatic stress for 17 years on average, and resistant to other treatments.
“The structure of the phase III clinical trial is intended to mirror that of the other studies,” writes MAPS. During a 12-week period of treatment, patients will undergo three one-day sessions, during which they will be provided with a dose of MDMA as well as psychotherapeutic support. At the same time, the trial provides for 12 therapeutic preparation and integration sessions. A control group will receive a placebo for this randomized trial.
“Phase III of this trial will begin next year and will assess the efficacy and safety of MDMA-assisted psychotherapy in patients with PTSD,” explains MAPS. The study will take place in Canada, the United States and Israel. Initially, 100 to 150 participants will be recruited.
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