The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. The study will take place in Vancouver and recruit 30 people with opioid, stimulant and / or alcohol use disorders. Syreon is leading the trial as a clinical research organization (CRO) with Numinus as the trial sponsor.
Numinus is pleased to share that several key steps have been taken since the start of the trial. announced in november . The protocol is now finalized, after undergoing two rounds of external peer reviews by a leading psychedelic research foundation. The overall structure selected for this protocol conforms to current best practices developed internationally for psilocybin assisted therapy. The administration of psilocybin will occur in the context of a behavioral intervention consisting of motivational enhancement therapy, which is a structured counseling approach based on the principles of motivational psychology and designed to produce rapid and motivated change. inside.
“Syreon is pleased to partner with Numinus to conduct this groundbreaking study into substance use disorders,” says Paul keown , founder and CEO of Syreon. “These are among the most complex and challenging areas of modern healthcare, with enormous clinical and societal consequences. Psilocybin is a promising new therapy for personalized care in this area, and Numinus and Syreon combine the in-depth medical knowledge and extensive testing expertise required for research experts in this expanding field of natural bioactive therapies. ”
Numinus is also proud to announce the appointment of several key study members, including Dr. Lindsay mackay , MD, CCFP, a clinician scientist and addiction specialist who has been selected as the principal investigator. Dr Mackay is a graduate of the British Columbia Center on Substance Use, the NIDA-funded International Drug Addiction Collaborative Medicine Research Fellowship, and has extensive experience in exploring psychedelics and new therapies as health treatments. mental health and addiction. Elena Argento , PhD, MPH, has been appointed Co-Principal Investigator. Argento works in collaboration with the BC Center on Substance Use to conduct and lead innovative research and interventions in response to the overdose crisis and is a postdoctoral researcher at the University of British Columbia .
While psilocybin remains a restricted substance in Canada , the evolving regulatory landscape has shown the potential to allow greater accessibility to psilocybin-assisted psychotherapy, particularly in light of Health Canada’s recent announcement of its intention to revise the Special Access Program (SAP). The PRIME trial is expected to contribute to the growing interest in expanding access to psilocybin-assisted therapy.
“We have made significant progress in developing the framework and a team of experts to conduct this compassionate access trial which will provide meaningful information on treatment methods for people with opioid use disorders, stimulants and / or alcohol, “said Dr. Evan wood , chief medical officer, Numinus.
Several new objectives are underway in preparation for the implementation phase, Syreon, as CRO, initiating study materials. Numinus will continue the ongoing establishment of a physical, technical and human resource infrastructure to support the trial of Compassionate Access, with the goal of enabling wider dissemination through SAP, if approved.
1 Health Canada recommends compassionate access to open clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” ( Special Access to Medicines Program: Guidance Document for Industry and Practitioners, published 2020-10-14 ). This program is unrelated to the US FDA Extended access program, sometimes called “compassionate use” or the Revolutionary therapy designation .
Numinus Wellness Inc. (TSXV: NUMI) is a healthcare and research company that creates psychedelic solutions to treat mental illness, addiction, and trauma.
Numinus Health offers treatment through clinics and virtual services, with clinics in Vancouver and Montreal .
Numinus R&D develops clinical and therapeutic protocols for use in treatments, in collaboration with research partners and regulators.
Numinus Biosciences develops formulations and methods for a safe supply, using licenses from Health Canada, scientific expertise and advanced technology.
About Syreon Corporation
Syreon provides a comprehensive suite of adaptive clinical trials, health economics and outcomes research ensuring the safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.
Syreon is partnering with an elite portfolio of global pharmaceutical companies and start-up biotechnology companies to accelerate the evaluation of new therapies and improve health outcomes. Its expert research services identify precise therapeutic needs, rapidly assess new health interventions, monitor clinical use, and define optimal economic value in today’s competitive healthcare environment.
Syreon scientists have contributed to many groundbreaking innovations, from the first successful signal inhibitors, chimeric and humanized monoclonal, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, cell therapy strains and other recent initiatives in precision medicine.
Syreon’s head office in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, suppliers, buyers and payers. Our services in all phases of study planning, operation, analysis and reporting ensure safe, efficient and value-oriented clinical use.
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SOURCE Numinus Bien-être Inc.
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