Leanna J. Standish, ND, PhD, LAcup, FABNO is a neuroscientist and physician living in Seattle. She has faculty appointments in the University of Washington School of Medicine Radiology Department, the University of Washington School of Public Health and at Bastyr University.
She is working towards obtaining approvals to conduct ayahuasca clinical studies in the United States. She uses functional magnetic brain imaging to study brain-to-brain communication and the ‘entangled minds’ hypothesis.
As a physician she specializes in naturopathic oncology with special interest in the treatment of stage 4 cancer.
Ayahuasca clinical research in the U.S.: Can we meet FDA and DEA regulations?
Ayahuasca has been studied in well designed clinical studies conducted in Brazil and Spain. These studies demonstrate that ayahuasca tea is both safe and effective for people with depression and alcohol/drug addictions. Unlike some other countries, ayahuasca is considered a controlled drug in the United States. There is much to learn about ayahuasca’s effects on the brain and the mind. However, in order for physicians and scientists to conduct legal ayahuasca research in the U.S., each study requires Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) as well as Institutional Review Board (IRB) approval. While daunting, it is possible to meet these regulations.
Dr. Standish’s lecture will describe progress over the last decade in studying the alkaloid content of ayahuasca teas used in South and North American ceremonies, studying the botany and horticulture of the two most commonly used plants for making ayahuasca tea (B. caapi and P. viridis) and developing a standardized ayahuasca medicine suitable for clinical research and obtaining IRB, FDA and DEA approval to conduct human research. In January 2015, Dr. Standish submitted an FDA IND for a dose escalation study of ayahuasca in healthy adults as a first step towards trials of ayahuasca in moderate recurrent depression and studies of the effects of ayahuasca on the brain using functional MR imaging. This lecture will present the DEA’s and FDA’s response and the work that must be done to move forward with ayahuasca human clinical research in the United States.
Ayahuasca and Consciousness Science
The potent effect of Ayahuasca on the inner experience of consciousness poses several questions including:
- What is the nature of reality?
- What is the nature of mind?
- Are the worlds and dimensions that are revealed during the ayahuasca experience ‘real’ or only ‘in the head’?
This presentation will summarize recent scientific evidence from physics and neuroscience that address these questions.