Vancouver psychedelics company gets Health Canada greenlight for MDMA therapy study

A B.C. psychedelics company has received federal approval to use MDMAto treat more than a dozen people suffering from post-traumatic stress disorder.

Numinus, a Vancouver-based health company specializing in psychedelic research, will treat 20 people suffering fromPTSD using MDMA-assisted therapy. On Monday, it confirmed the study had received regulatory approval from Health Canada.

The move comes as a growing body of research attempts to uncover thehealth benefits of MDMA, particularly in treating PTSD. Previous clinical trials led by theMultidisciplinary Association for Psychedelic Studies(MAPS) showed thatmore than half of thesubjects no longer qualified for a diagnosis of PTSDtwo months following treatment thatincluded three sessions of MDMA-assisted therapy .

MAPS is sponsoring the Numinus study.

MDMA, commonly referred to as ecstasy, is controlled under the Controlled Drugs and Substances Act, and is illegal to useunless authorized for medical or scientific purposes. Approvedstudies use medical-grade MDMA in clinically supervised settings.

"This study is about access, and about safety," saidDr.Devon Christie, Numinusmedical and therapeutic services director.

"We're providing safety data and efficacy data to Health Canada that's going to help support the eventual regulatory approval of this medication," said Christie.

Best practices

Christie is leading the Vancouver-based trial, which she says will build on how MDMA-assisted therapy can be delivered. She says the goal is to understand how the treatment could be used in a "real-world setting" and establish best practices.

Participantswill meet with two therapists in multiple sessions, including a preparatory session and the study drug session which lasts a full day. During the drug session, participants also spend timelistening to music. Study rooms are made to be calming, including plants and greenery, as opposed to a traditional clinical setting.

In previous clinical trials, patients would receive the treatment and spend the night on site as a safety precaution. That will not be required under the Numinus trial.

"That's one example of trying to reduce the cost of the treatment, and also to reduce things that were implemented in efficacy studies that are no longer required in a real-world context," she said.

Numinus plans to start recruiting participants later this summer.

Anticipating wider use

In addition to sponsoring the Numinus trial, MAPS is overseeing a second Phase 3 trial on MDMA-assisted therapy. It is also conducting an exploratory study as to whether the drug can be used to treat eating disorders.

Christie is hopeful those efforts will also deliver promising results.

She anticipates the drug could receive federal approvals for wider use both in the U.S. and Canadawithin two to three years.

"I don't think Health Canada could refuse to approve this treatment with the level of efficacy and safety and the dire need that this treatment is meeting," she said.