Clinical Research, Plant Medicines & the FDA.
Berra earned her PhD in Molecular, Cell, and Developmental Biology from the University of California, Santa Cruz in 2010. She utilizes her scientific training and experience in for-profit pharmaceutical research to support MAPS’ work to develop, design, and implement clinical psychedelic research in the U.S and beyond.
She earned her BS in Biological Science from Stanford University in 2001, with an emphasis on the neurobiology of drugs. Prior to entering graduate school, Berra worked as a Research Associate with Geron Corporation screening for drugs that activate telomerase, and with Millennium Pharmaceuticals on Phase 1 clinical trials in patients with Acute Myeloid Leukemia.
Berra joined MAPS in 2009 in order to work with an organization where profit wouldn’t dictate the agenda of scientific research. Since then, she has been actively involved in the ongoing Phase 2 clinical development of MDMA-assisted psychotherapy with an eye towards Phase 3 clinical trials.
Clinical Development of Plant Medicines and
Plant-Derived Semi-Synthetic Compounds as Regulated by FDA
Many of the medicines and drugs we are familiar with originally come from plants. The Food and Drug Administration (FDA) regulates botanical drug products intended to affect the structure and function of the body as either dietary supplements or as drugs, depending on claims made by the sponsor developing them for marketing. Drugs claiming to diagnose, mitigate, treat, cure, or prevent a specific disease must go through clinical trials to definitively demonstrate safety and efficacy. As a pharmaceutical sponsor, the Multidisciplinary Association of Psychedelic Studies (MAPS) intends to develop 3,4-methylenedixoymethamphetamine (MDMA) and marijuana, both Schedule 1 Controlled Substances, into prescription medicines to treat chronic psychiatric disorders. Berra Yazar-Klosinski, Ph.D., Clinical Research Scientist of MAPS, will present on a comparison of the clinical development of MDMA, a chemically modified compound derived from sassafras, and smoked marijuana, both of which are currently in an international series of Phase 2 clinical trials for Posttraumatic Stress Disorder (PTSD). Preliminary data from multiple Phase 2 clinical trials with MDMA will be reviewed.
Forces Behind the Movement – Presentation of Organizations
Panelist: Berra Yazar-Klosinski, PhD
A representative from each organization will describe their organization, their mission and provide a status on current activities.
The Aware Project – Ashley Booth
Botanical Dimensions – Kathleen Harrison
ERIE – Larry Norris
GITA – John Harrison
ICEERS – Ben De Loenen
MAPS – Berra Yazar-Klosinski
Nierika – Anja Loizaga-Velder
Women’s Visionary Congress – Annie Oak
Moderator: Kenneth Tupper, PhD
More About Berra Yazar-Klosinski, PhD:
MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults by Alicia L. Danforth, Christopher M. Struble, Berra Yazar-Klosinski and Charles S. Grob.
Can MDMA Play a Role in the Treatment of Substance Abuse? by Lisa Jerome, Shira Schuster and Berra Yazar-Klosinski.
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study by Michael C. Mithoefer et al.
Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases by Peter Gasser et al.
FDA guidance on clinical development of botanical products
FDA guidance on Conducting Phase 2 and Phase 3 clinical trials
FDA guidance on Dietary Supplements
Conducting Clinical trials with Controlled Substances
More about the Multidisciplinary Association for Psychedelic Studies (MAPS)
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
We further our mission by (1) developing psychedelics and marijuana into prescription medicines; (2) training therapists and working to establish a network of treatment centers; (3) supporting scientific research into spirituality, creativity, and neuroscience; and (4) educating the public honestly about the risks and benefits of psychedelics and marijuana.
We envision a world where psychedelics and marijuana are safely and legally available for beneficial uses, and where research is governed by rigorous scientific evaluation of their risks and benefits.
Our top research priority is MDMA-assisted psychotherapy for chronic, treatment-resistant posttraumatic stress disorder (PTSD). We are also conducting an ongoing study of MDMA-assisted psychotherapy for social anxiety in autistic adults, and planning a study of MDMA-assisted psychotherapy for anxiety associated with advanced illness.
Our other research projects include LSD-assisted psychotherapy for end-of-life anxiety, and ayahuasca and ibogaine for drug addiction. We are also working to initiate a study of smoked marijuana for PTSD in veterans.
In addition to conducting scientific research, MAPS educates the public about the risks and benefits of psychedelics through the tri-annual MAPS Bulletin, a monthly Email Newsletter, and groundbreaking books on psychedelic research.
Maps.org keeps track of the latest research news and hosts the world’s largest online collection of psychedelic research papers. MAPS’ educational conferences and events provide researchers and attendees with unique networking opportunities and help scientists share knowledge with the wider public.
MAPS also supports psychedelic harm reduction and education services at events around the world. The Zendo Project is an onsite harm reduction service providing a tranquil space and compassionate care for people having difficult psychedelic experiences at festivals and other events.
Recommended Reading: Books
Acid Test: LSD, Ecstasy, and the Power to Heal by Tom Shroder. Available at the Maps Store.
LSD Psychotherapy by Stanislav Grof, MD. Available at the MAPS Store.
Manifesting Minds: A Review of Psychedelics in Science, Medicine, Sex, and Spirituality edited by Rick Doblin, PhD., and Brad Burge. Available at the MAPS Store.
Recommended Reading: Articles
“The Trip Treatment” by Michael Pollan in The New Yorker, February 9, 2015.
“PTSD and Pot: The Fight to Get Veterans Some Weed” in Rolling Stone, December 9, 2014.
Press Release: “MAPS Announces Formation of New Public Benefit Corporation to Conduct Research and Sell MDMA by Prescription,” February 13, 2015.
The January 2015 issue of the British Journal of Psychiatry featured two editorials on psychedelic therapy research. The cover art (“The Shulgins and their Alchemical Angels”) was presented to Sasha and Ann Shulgin by artist Alex Grey at MAPS’ Psychedelic Science in the 21st Century conference in April 2010.