PT448 – Deborah C. Mash, Ph.D. – Ibogaine, Noribogaine, and the Challenges of Federal Drug Policy
Oct 6, 2023
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Joe interviews Deborah C. Mash, Ph.D., leading researcher in addiction and brain disorders. She talks about ibogaine research challenges, the need for partnerships, and collecting Phase II and III data. Also discusses her study on Cocaethylene, deaths related to iboga, and the French use of noribogaine. Deb Mash shares her experience at a psychedelics science event and highlights the potential of Ibogaine for addiction treatment. Talks about the risks and challenges of using Ibogaine, conservation efforts within the indigenous community, and the challenges of implementing an ibogaine initiative.
Conducting clinical trials is crucial to demonstrate the safety and efficacy of Ibogaine for addiction treatment.
Collaboration between regulatory agencies, academics, and clinicians is essential to ensure responsible use and development of Ibogaine.
Deep dives
The Potential of Ibogaine for Addiction Treatment
Deborah Mash, the CEO and founder of DemiRx, discusses the potential of Ibogaine as a medication for the treatment of addiction. She highlights the importance of conducting clinical trials in order to demonstrate the safety and efficacy of Ibogaine. Mash emphasizes the need for pure and consistent Ibogaine products and proper dosing to minimize risks. She also discusses the importance of collaboration between regulatory agencies, academics, and clinicians to ensure the responsible use of Ibogaine.
The Challenges in Bringing Ibogaine to the Market
Mash explains the challenges involved in bringing Ibogaine through the FDA pipeline and obtaining approval for its use in addiction treatment. She highlights the need for an investigational new drug (IND) application and the importance of gathering safety and efficacy data through clinical trials. Collaborative efforts with stakeholders, including regulatory agencies, researchers, and clinicians, are crucial for the successful development and approval of Ibogaine.
State-level Initiatives for Ibogaine
Mash discusses the potential for state-level initiatives to pave the way for the use of Ibogaine in addiction treatment. She explores the possibility of partnerships between state regulatory bodies, academic institutions, and private companies to conduct pilot studies and gather safety and efficacy data. Such initiatives would provide an opportunity to demonstrate the benefits of Ibogaine and accelerate its availability for patients in need.
Innovative Approaches: VR Integration
Mash introduces the development of a virtual reality (VR) device called the Ibogaine Sanctuary. This VR integration aims to enhance the psychoeducation, preparation, anxiety relief, and post-Ibogaine integration process. By combining immersive technology with therapeutic content, this innovative approach aims to optimize the therapeutic potential of Ibogaine treatment.
In this episode, Joe interviews Deborah C. Mash, Ph.D.: neuroscientist; Professor Emerita of Neurology and Molecular and Cellular Pharmacology at the University of Miami Miller School of Medicine; and leading researcher in addiction and brain disorders for over 30 years.
She is also the CEO and Founder of DemeRx Inc., a clinical stage drug development company working to advance ibogaine and its active metabolite, noribogaine, for the treatment of opioid use disorder. She talks about the Federal and state complications behind ibogaine research, the need for partnerships between clinics and researchers, what needs to be done to collect much needed Phase II and III ibogaine data, and why this all has to be in partnership with the FDA.
And she discusses much more: her story of how studying Cocaethylene led to her finding out about ibogaine; ibogaine and QTc-prolongation; deaths related to iboga and the amount of variables that aren’t considered; how the French were essentially using noribogaine in the 1930s; and, as this was recorded at Psychedelic Science 2023, her thoughts on the event and Rick Doblin’s opening statement. Click here to head to the show notes page.
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