If this was a 1990’s news website we’d be putting all sorts of animated siren gifs all over the top of this piece because, I ain’t gonna lie: It’s a big one.
Numinus Wellness (NUMI.V), who we’ve been eyeing at a distance for some time because we love shrooms as an industry but don’t trust anyone to do it right just yet, has released news that has all the hallmarks of this right-doing thing we see so little of.
Numinus Wellness Inc. and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corp. (MAPS PBC), a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), have signed a collaboration agreement that will seek approval to deliver MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) through a single-arm, open-label, compassionate access trial (1). This clinical trial will be the first of its kind in Canada and will take a meaningful step in furthering the accessibility of MDMA-assisted treatment options for those experiencing PTSD around the world.
Layman’s translation: This is the first step towards a world where molly might become legal.
We all love it.
As with shrooms now, and cannabis before it, the medical possibilities of low dosage MDMA application in a psychotherapy setting are at the heart of an exploding field of research, but just as with shrooms now and cannabis before that, the number of companies claiming they’re going to run clinical trials dwarfs the number actually running them.
In that respect, the Numinus news ain’t a grift. MAPS doesn’t play.
Through the completion of six phase-2 trials and continuing phase-3 trials, MAPS and MAPS PBC have undertaken groundbreaking research demonstrating that MDMA-assisted psychotherapy — which recently received breakthrough-therapy status from the United States Food and Drug Administration — may provide sufficient benefit to patients experiencing PTSD to support approval from the FDA.
This compassionate access trial, if approved, will be conducted at Numinus’s Vancouver clinic, providing MDMA-assisted psychotherapy to an initial 20 individuals experiencing PTSD, and collecting outcome and safety data for Health Canada. Numinus’s physicians, therapists and staff will be trained to deliver the treatment under MAPS’ clinically tested PTSD treatment protocol prior to approval by Health Canada.
Credit where it’s due: This is the sort of advancement I’ve been waiting for in the psilocybin sector – assuming Health Canada abides.
If they do… Boomshanka.
Numinus was up a smidge on the news, which tells me a lot of people are really unsure what’s the what when it comes to the clinical trial process.
Take it from me – and understand Numinus isn’t a client. I’m just happy to respect the work when the work is being done, and if we can get a solid movement happening in MDMA microdosing, the world will be a better place.
— Chris Parry
FULL DISCLOSURE: No commercial arrangement.