MAPS опубликовал брошюру исследователя с данными за три десятилетия по ибогаину

- MAPS provided the first outside funding for the University of Miami ibogaine research program in the 1990s - The 1994 IND is not a substitute for current safety and sourcing data - Earlier this summer, MAPS published its Ibogaine Investigator's Brochure, a free companion resource covering three decades of data; the 1994 filing predates An IND is the authorization issued by the U.S. Food and Drug Administration that permits a specific research team to administer an investigational drug to people under a specific protocol. An Investigator's Brochure is the scientific reference document that tells a research team what is known about the drug: its pharmacology, its dosing, its risks, and how those risks are managed. The two work together: one is regulatory permission, and the other is the knowledge required to responsibly apply that permission when conducting clinical trials or treating patients. MAPS' involvement with the Miami program goes back to its beginning. In a 1995 progress report published in the MAPS Bulletin, University of Miami researchers wrote that they were "very grateful to MAPS for providing initial support for the Ibogaine Research Project when other sources of funds were not available," and that MAPS funding supported human metabolism studies and preliminary work behind their submissions to the FDA. The 1994 file reflects what was known about ibogaine at the time it was written. In the decades since then, the field has advanced its understanding of ibogaine's cardiac effects, its pharmacokinetics, and the outcomes reported from treatments occurring in unregulated settings around the world. MAPS has since published its own Ibogaine Investigator's Brochure to put that record in one place, at no cost, for anyone who needs it: academics, clinicians, policymakers, ethics committees, and the public. Lead author Brock Pluimer, Ph.D., prepared it with editorial support from Richard Harris, Ph.D., and MAPS Director of Research Philippe Lucas, Ph.D. "When MAPS provided initial funding to Deborah Mash and Juan Sanchez-Ramos at the University of Miami in the early 1990s, ibogaine research was nearly invisible on the federal map. Seeing the file they built become a national asset is a meaningful moment for a field with a very long memory. The next chapter of ibogaine research should start from what the field understands today, not from where we had to leave off in 1994. It should also be understood that a federal file cannot supply a relationship with the communities in Gabon where iboga grows. Iboga is a limited resource with a source community, and moving quickly in the United States does not suspend that obligation. Nor should it." - Rick Doblin, Ph.D., Founder and President, MAPS MAPS has consistently welcomed federal investment in psychedelic research while attaching the same conditions regardless of which administration proposes it: ethical and rigorous science, transparent and evidence-based review, participant safety, equitable access, and provider training. Those conditions apply here. Ibogaine carries documented cardiac risk that requires screening and monitoring, and expanding access without expanding that capacity puts people in danger. Iboga is a slow-growing plant whose harvest affects the people, traditions, and land of Gabon. Demand generated in the United States will be felt there first. MAPS supports Americans' access to promising therapies and believes that access is best delivered in clinical settings, with the screening, monitoring, and informed consent that ibogaine specifically requires. "The University of Miami's decision to contribute this legacy application to the public record rather than to a private sponsor is a welcome gesture toward open science. We hope that it inspires other researchers, regardless of their approach or intentions, to follow suit. Ibogaine's clinical development will move more safely and responsibly if stakeholders collaborate instead of compete.” - Ismail L. Ali, J.D., Co-Executive Director, MAPS The ibogaine Investigator's Brochure is available at no cost at maps.org/ibogaine. MAPS encourages every research team, clinician, and regulator working on ibogaine to use it and to reach out with contributions as new data and research arise. ABOUT MAPS Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful use of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Resilient Pharmaceuticals (formerly Lykos Therapeutics and the MAPS Public Benefit Corporation) and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $150 million to advance psychedelic research, change drug policy, and shape culture. Media Contact: