About Us

“Our objective is to find new and effective methods to relieve anxiety and suffering, and contribute to the understanding of neuroscience and the relationship of the mind and body. This is a frontier of research that will shape our future in important ways that we are just beginning to appreciate.”

—Bill Linton, Executive Director & Co-Founder

Usona Institute is a 501(c)(3) non-profit medical research organization dedicated to supporting and conducting pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our focus is on alleviating depression in people for whom current medical treatments fall short in offering relief and a better quality of life.

Based in Madison, Wisconsin, Usona was founded in 2014 by Bill Linton, CEO and Founder of the international life sciences company Promega Corporation, and Malynn Utzinger, M.D., Director of Integrative Practices at Promega Corporation. The Institute was founded shortly after Bill was inspired by the meaningful impact that a psilocybin study at Johns Hopkins University had on a friend suffering from cancer.

To learn more about how Usona came to be founded as a non-profit medical research organization, please see the video below featuring Director of Integrative Medicine & Co- Founder Malynn Utzinger, M.D.

Collaborators

D’Or Institute for Research and Education (IDOR)

Hans Knöll Institute

Imperial College London

Heffter Research Institute

MAPS Public Benefit Corporation

Swiss Neuromatrix Foundation

University of Wisconsin Hospital and Clinics

University of Wisconsin–Madison School of Pharmacy

Michael Bogenschutz, MD, New York University

Robin Carhart-Harris, PhD, Imperial College London

Roland Griffiths, PhD, Johns Hopkins University School of Medicine

Charles Grob, MD, Harbor-UCLA Medical Center

Dirk Hoffmeister, PhD, Friedrich Schiller University and Hans Knöll Institute

Matthew Johnson, PhD, Johns Hopkins University School of Medicine

Benjamin Kelmendi, MD, Yale School of Medicine

Janis Phelps, PhD, CIIS Center for Psychedelic Therapies and Research

Stephen Ross, MD, New York University

Franz Vollenweider, MD, University of Zürich

Joshua Woolley, MD, PhD, UCSF School of Medicine

Statement on Collaboration

Usona Institute is able to accomplish its mission of enabling and supporting psychedelic research and FDA registration of psilocybin therapy only through collaboration with many scientists, clinicians, research centers, expert consultants, and philanthropists globally.

Usona will continue to build relationships and collaborations with all organizations that share our philosophy of delivering approved therapies to those in need based on safety, high quality active drug materials, and highly-trained guides and practitioners, at the lowest possible cost.

Usona is building an advanced chemistry capability with our cGMP contract suppliers and through approved research chemistry facilities at two locations in the United States. High quality materials will be supplied to qualified research and therapy centers for basic, applied, and clinical research at cost or gratis, for the purpose of accelerating the pace of research for these important therapies.

Expertise on the Usona team includes:

Study design and protocol development

ICH GCP (Good Clinical Practice) compliance

FDA drug development

Clinical research leadership

Multi-site drug development management

Contract research organization (CRO) management

CIIS-trained guide expertise

Complex clinical drug development program management

Small molecule design and scale-up with full analytical capabilities

Preclinical safety and pharmacology research

Translational methodologies

Navigation of regulatory agencies and requirements

Psychiatry

Public health policy

Open Science

As a non-profit medical research organization, Usona Institute is dedicated to working for the public good through the advancement of scientific knowledge and the alleviation of mental suffering. Guided by this purpose, Usona—along with a collection of like-minded organizations, scientists, practitioners, and philanthropists—has signed a statement to make public the scientific discoveries and processes that arise from its research.

We believe that openness, transparency, and collaboration will move this field of scientific knowledge forward most efficiently and honorably, and we are pleased to commit ourselves to this approach. For more information, please follow this link.



For Patients & Caregivers

With the help of clinical trial volunteers, Usona’s research aims to further the understanding of psilocybin and other consciousness expanding medicines to relieve mental suffering.

Learn more about clinical trials:

Explore Usona’s clinical trials

Trials on clinicaltrials.gov

For patients facing a serious or life-threatening condition who are unable to participate in a clinical trial and have exhausted all other options, FDA or the overseeing regulatory authority in your country may allow a licensed physician to provide their patient with an unapproved drug. In the US, this is called “Expanded Access” and elsewhere has been referred to as “Compassionate Use.”

Learn more about Usona’s Expanded Access policy.

If you have any questions about Usona’s Expanded Access policy or to inquire about Expanded Access use of a Usona investigational drug, please contact us.



Funding Policy

Per the policy adopted by its Board of Directors, Usona Institute will reimburse indirect costs at a rate of up to 22.5% for clinical research, and a rate of up to 15% for non-clinical research. This policy does not apply to gifts made to research institutions and/or affiliated non-profit entities, which are to be used only toward direct costs.



Frequently Asked Questions

About Usona When was Usona Institute founded?

Usona was founded in 2014 by Bill Linton and Malynn Utzinger, MD, in Madison, Wisconsin. How many people are on the Usona team?

There are approximately 20 full- and part-time employees and consultants. What is a Medical Research Organization (MRO)?

An MRO is a specific type of 501(c)(3) non-profit organization, designed to be engaged in the continuous active conduct of medical research. How did Usona come about and why this area of exploration?

It all started with an inspiring event for co- founder Bill Linton. Bill witnessed the transformation of a friend and neighbor who participated in a Johns Hopkins study for people with terminal cancer. She went from a state of depression and chronic anxiety to one of lasting ease and calm. What is Usona’s role in psilocybin or other related research?

Usona is a research sponsor, which means that we take on the activities of drug development, all aspects of developing study protocol, and monitoring data and safety. As a research sponsor, Usona also assumes the responsibility of supporting, directing, and managing the clinical studies. This is a direct level of engagement with the work and it differs from foundations and grant-making entities that strictly provide financial support. What is the significance of Usona’s non-profit status?

As a 501(c)(3) non-profit medical research organization, Usona’s purpose and commitment is to serve the public good through scientific rigor and discovery. Guided by this purpose, Usona works with an approach that values scientific integrity and transparency for the benefit of society by striving to place our research results in the public domain. Our research is not led by the desire for commercial gain, but by the scientific inquiries that point toward the development of promising medicines and therapeutic frameworks for those in need. Does Usona have any experience in this area?

The Usona team members and external consultants hold a depth of expertise and experience on depression, conducting clinical studies, developing pharmaceutical grade products and working with the FDA. At its formation, Usona supported a portion of a psilocybin pharmacokinetics study at the UW-Madison School of Pharmacy. Members of the Usona team regularly collaborate and engage with global thought leaders in a variety of scientific fields. Who is funding the trials?

Usona relies on a number of generous donors to fund our present and future operations. Is Usona in favor of legalizing psilocybin or other psychedelics?

We are a science organization, not a policy or advocacy group. Usona’s goal is to complete clinical trials that will assist the FDA in evaluating the efficacy and safety of psilocybin-assisted psychotherapy as a potential legal medication and therapy for people suffering from depression. Will Usona be getting into other psychedelic compounds?

Our first priority at this time is the clinical development of psilocybin. We’re open to new scientific explorations that may emerge as we continue to engage in this field of research. About the Trials When are your trials starting, and how long will the study take?

Enrollment in our initial clinical trial has begun, and we expect the study to take 1 – 1.5 years to complete. Are you initiating a Phase 3 study?

We are currently initiating a multi-site Phase 2 clinical trial in the MDD population – outcomes from this trial will inform and optimize the intended Phase 3 trial to follow. Where will your trials take place?

We intend for our trial to take place at 7 research sites throughout the United States. What institutions are you collaborating with for the Phase 2 study?

We are collaborating with a number of institutions in the past, including Johns Hopkins University, New York University, University of California – San Francisco, University of Wisconsin – Madison, Yale University, Great Lakes Clinical Trials (Chicago), and Segal Trials (Miami). How many research volunteers and Clinical Facilitators (guides) will be needed for your trials?

~80 volunteers will be needed for our upcoming Phase 2 trial, and each research site will likely need a different number of facilitators depending on their expected enrollment. Generally, there will be 4-6 Facilitators at each site. How will Clinical Facilitators be trained for your trials?

All Clinical Facilitators (guides) participating in Usona-sponsored studies will complete a combination of in-person and online trainings in order to qualify for the position. Are you doing a trial in the cancer population?

The cancer population is one that we care about immensely. As we move forward in our work, our aim is to expedite the regulatory process toward FDA approval of psilocybin for depression in a way that opens up access to this medicine for as many people as possible – this includes people who experience depression as a comorbidity to cancer, among many other diseases. Our initial trial in the MDD population will inform how we can best move forward with final stage trials that will get this treatment to people suffering from cancer and depression as soon as possible. Are you recruiting? How can I refer someone to your trial?

Recruitment has begun; please refer anyone interested in learning more about our trials to Usona’s clinical trials website: www.usonaclinicaltrials.org About Our Psilocybin How is it being supplied and by whom?

Pharmaceutical-grade product is being produced by a collaborating contract pharmaceutical manufacturer outside of the US. While many cultures have utilized psychoactive mushrooms in sacred ceremony for millennia, the psilocybin that we will use for research is synthesized so that purity and consistency is closely controlled. Who can access it?

At this time, Usona will provide psilocybin to qualified researchers at no cost. Anyone who makes a request to receive psilocybin for research purposes must submit full protocol and other documentation for review and evaluation. To learn more, see our Investigational Drug Supply Program. Do you intend to provide this substance publicly?

Pending FDA approval, we intend that the psilocybin would be made available as part of a carefully devised and controlled therapeutic protocol, administered by trained therapists. It would not be given to a patient/client for home or independent use. About Facilitator Training What is a Clinical Facilitator, and what is their role in Usona’s studies? Clinical Facilitators play a central role in ensuring participant safety throughout the study. Facilitators are responsible for 1) preparing each participant for his, her, or their dosing session; 2) monitoring the participant’s physical and psychological well-being throughout the dosing session; and 3) supporting the participant throughout the integration sessions following the dosing session. Each participant will be assigned a Lead Facilitator and a Co-Facilitator. Lead and Co-Facilitators are responsible for developing a strong therapeutic rapport with each participant, supporting the participant to fully attend to their study experience while addressing issues related to their major depressive disorder (MDD) diagnosis. What qualifications do Usona research Facilitators need to have? The FDA has mandated the following qualifications for Lead Facilitators and Co-Facilitators participating in Usona’s Phase 2 psilocybin and MDD clinical trials (PSIL201): Lead Facilitators Lead Facilitators at all study sites will be doctoral level psychotherapists or physicians with experience in the psychological treatment of MDD. Specifically, the Lead Facilitators will be Clinical and Counseling Psychologists (PhD/PsyD) or psychiatrists and appropriately trained/experienced physicians (MD or DO). Co-Facilitators Co-Facilitators at all study sites will hold a minimum of a bachelor’s degree in a mental health field. Preference will be given to those with experience working in the mental health field and/or prior experience working in clinical research trials, especially with psilocybin. Does Usona offer Facilitator trainings? All Lead and Co-Facilitators are trained on important safety protocols and complete a study-specific training program developed by Usona Institute and expert collaborators. Usona’s Facilitator training program is currently limited to researchers participating in our psilocybin and depression clinical trials and is not open more widely to other clinicians or researchers at this time. As Usona’s clinical trials advance, training opportunities may become available to qualified clinicians – information on any such opportunities will be announced via our website, newsletter, and other media sources. Is Usona hiring Facilitators for its current/ upcoming studies? Please note that it is the responsibility of each participating clinical research site to identify and hire Facilitators. Usona does not post Facilitator employment opportunities on behalf of research sites on their websites and does not respond to CV’s or requests.

Newsletter Archive

Usona Institute’s newsletters offer a view into our many dynamic program areas. To learn more, please follow the links to our archived newsletters below:

2020

2019

2018

2017

If you would like to sign up for future editions of our newsletters, please subscribe by following this link.

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