What Is A Compassionate Access Trial? Numinus CSO & Co-Founder Stacey Wallin Has The Details

Earlier this week, The Dales Report sat down with Stacey Wallin, the chief strategy officer and Co-Founder of Numinus, to discuss the company’s ongoing compassionate access trials and its work with the Multidisciplinary Association for Psychedelic Studies (MAPS).

Numinus And MAPS Work Together

MAPS’ most recent study, a phase three randomized clinical trial of MDMA-assisted therapy for the treatment of PTSD, made headlines in major publications around the world for its significant results: following the trial, two thirds of participants who received MDMA in conjunction with psychotherapy no longer met the diagnostic criteria for PTSD. Wallin commented on its success, and on Numinus’ concurrent research.

“What a testament to the great work that’s happening in the broader space, and the efficacy of the maps protocol and approach,” she said. “We’re already using the MAPS protocol and MAPS training program, and working hand in hand with MAPS, so we’re really actually carrying out another version of the same study that generated such fantastic results.”

Ongoing Studies

The company currently has two compassionate access trials in the works: the first, as Wallin noted, mimics the MAPS trial (MDMA assisted psychotherapy for PTSD) and the second focuses on psilocybin-assisted psychotherapy for polysubstance use disorder (the use of more than one substance at the same time).

“It’s very relevant and applicable research to what’s actually happening on the ground. It aligns acceptance criteria into the study with the reality for many folks that are actually navigating substance use disorders,” Wallin said of the psilocybin study.

What Is Compassionate Access?

What separates Numinus’ research and clinical work from other players in the psychedelic space has a lot to do with the structure of the company’s trials. As Wallin outlined, the goals of the work are to provide evidence around delivery mechanisms, add to the evidence body, and form regulations around increasing access for those that need it the most.

“Traditionally, [clinical trial research] can be double blinded,” she said. “In our case, every person who is accepted into the study receives the treatment, so there’s no other arm or second way that you can participate. Every person receives compassionate access to the same medication and the same protocol.”

To learn more about the compassionate access trials and Wallin’s own journey with psychedelics, watch the video above.


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