Vancouver to host next phase of ecstasy-assisted therapy trial
After pilot using MDMA to support post-traumatic stress disorder counseling, a second site in Vancouver is closer to seeing a larger study.
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After completing a controversial experiment offering trauma therapy to six patients on MDMA — the illegal drug popularly known as ecstasy — Vancouver is poised to host a second, much larger study as early as June, Metro has learned.
Researchers with the Multidisciplinary Association for Psychedelic Studies (MAPS) hope to expand their six-patient trial to roughly 20 patients who have previously untreatable post-traumatic stress disorder.
If approved, it will be part of an international effort involving hundreds of people with severe trauma, including sexual abuse survivors, soldiers and first responders.
On Nov. 29, the U.S. Food and Drug Administration accepted their project’s Phase Two data, paving the way for a large-scale third phase of research, the final step before permitting ecstasy prescriptions.
“They’ve accepted our Phase Two clinical data and said we don’t have to do more work,” said MAPS Canada chair Mark Haden, an adjunct professor at UBC’s School of Population and Public Health, told Metro. “A significant hurdle has just been crossed.”
MAPS’ larger Phase Three study has already selected a Vancouver site, led by Haden and a team of specially trained professional psychotherapists, and he hopes to involve a local hospital, too.
In the previous experiment, more than 100 PTSD patients were administered a 125 mg dose of MDMA followed by several hours of counselling with two therapists. They slept over on site, and underwent more therapy the next day. They took a half-dose with therapy after a month, and a follow-up after a year to see if their symptoms changed.
In fact, after just two MDMA-assisted sessions, 56 per cent of subjects no longer met PTSD criteria, rising to 66 per cent 12 months later, according to MAPS.
MDMA — methylenedioxymethamphetamine — is known as an empathogen, meaning it can generate feelings of empathy and trust. Under carefully controlled therapeutic
“PTSD is an unconscious tape loop that’s buried in someone’s unconscious mind,” Haden explained. “They can’t access it easily, but it generates a lot of emotional turbulence, especially in response to a trigger.
“MDMA allows access to the tape loop because it’s no longer fear-based.”
If the FDA green-lights the next phase’s protocols, MAPS will then submit those approved plans to Health Canada in the new year — ensuring the research methods are identical despite international sites.
Phase Two was “set it up like a dress rehearsal, with everything as perfect as you can do it but just with a smaller sample size,” he said. “But you can’t get a statement that is generalizable to the general population.”
If Phase Three succeeds, by 2021 MDMA could be prescribed for use by any qualified psychotherapist — but only for use in therapy, Haden cautioned.
Before then, MAPS Canada is raising money online for its research.
“It’s not funded by pharmaceutical companies,” Haden quipped, “because we’re actually getting people off mental health medications with what we’re doing.”