Center for Psychoactive Substances Research Accelerates the Search for Therapeutics

The new center at the University of Wisconsin-Madison School of Pharmacy leverages clinical and transdisciplinary expertise in the emerging field of psychedelic-assisted therapy.

By Katie Gerhards

In 2014, the University of Wisconsin–Madison campus became the site of the first Phase 1 clinical trial for psilocybin. Since that study, which was led by UW–Madison School of Pharmacy Professor Paul Hutson, the campus has steadily become a powerhouse of psychedelic research aimed at treatments for mental health conditions ranging from severe post-traumatic stress disorder (PTSD) to opioid use disorder. “We are one of a handful of academic sites in the U.S. that have a history of doing research with psychedelics,” said Hutson. “And we’re one of even fewer to do it at a quality and caliber high enough to be acceptable by the U.S. Food and Drug Administration for a New Drug Application.”

To provide infrastructure and other resources to stay on the cutting edge of this emerging field, the School of Pharmacy is launching the UW Transdisciplinary Center for Research in Psychoactive Substances. The new center reaches across campus to accelerate scholarly research into the science, history and cultural impact of psychedelic agents, in addition to the potential therapeutic use of psychoactive substances. “From cannabis to psilocybin (magic mushrooms) and MDMA (ecstasy), psychoactive agents are the new frontier for potential new therapies and medications,” said Hutson, the center’s founding director.

Therapeutic Promise

“Early studies have showed a dramatic impact on depression from one dose of psilocybin in a structured research setting. Similarly, when combined with psychotherapy for the treatment of PTSD we’re seeing dramatic benefits of the inclusion of MDMA, with a tripling of the response rate or remission rate for PTSD,” Hutson said. Importantly, the MDMA was not used alone, but as part of active, professional psychotherapy. Earlier [in 2021], School of Medicine and Public Health faculty Randall Brown and Christopher Nicholas co-authored a paper published in Nature reporting that MDMA helped 67 percent of study participants drop below the diagnostic criteria for PTSD and 33 percent meet the criteria for remission.

“There appears to be real promise in the treatment of a number of often refractory conditions related to addiction and mental health,” said Brown. “We have a lot to learn yet about possibilities and about optimal implementation and dissemination.” Four clinical trials in phases 1 to 3 are currently underway at UW–Madison to prepare for submitting applications for new drugs to the FDA, such as studying the efficacy of psilocybin as treatment for major depression and opioid addiction.

Cody Wenthur, assistant professor in both the School of Pharmacy’s Pharmaceutical Sciences and Pharmacy Practice Division and a member of the center’s executive committee, is also seeking ways to make ketamine a better therapeutic for depression by blocking some of the drug’s negative impacts. He is collaborating with Hutson and Nicholas to find out if it’s possible to observe therapeutic effects of psilocybin in the absence of memory of the psychedelic experience.

In addition to his findings about MDMA and PTSD, Brown is also working toward the therapeutic use of psilocybin for opioid use disorder and major depressive disorder. Nicholas is applying psychedelic therapy to methamphetamine use disorder. “I anticipate FDA approval of psilocybin and MDMA within the next five years, and the UW Transdisciplinary Center for Research in Psychoactive Substances will help meet the need for more research into these applications, as well as others, that could dramatically improve patients’ lives,” said Hutson.

Infrastructure and Services

Although numerous researchers around campus are already engaging in this work, the center will help provide infrastructure to help them expand their studies and even attract new researchers. “Similar to other types of chemical or biological research that need specific, expensive instrumentation, doing work with psychedelic-assisted psychotherapy requires dedicated infrastructure—trained guides, a study space, proper DEA licensing—all of the things that surround the study design itself,” said Wenthur.

Center members will have access to the School of Pharmacy’s current study space, which is one of few facilities like it in the world. Set up like a living room, it’s equipped with the comforts of home alongside monitoring devices to ensure participant safety and study replicability. Studies involving psychoactive agents require keeping a close eye on participants, both their physical and mental state. For each study, one or two trained guides or therapists protect the space and take care of the patient throughout their dosing session. The center plans to have one trained psychotherapist on staff to serve as a treatment guide and will also offer trainings to members of research groups. “By having these resources available to other investigators, we can potentially increase the number of available grants that are awarded to UW,” said Wenthur.

Another benefit of the center is in the paperwork: Hutson is one of few researchers who hold the necessary investigational new drug exemption and Schedule 1 license for clinical projects that involve drugs like marijuana, psilocybin and LSD. By collaborating with the center, researchers will be able to leverage Hutson’s proven expertise and licensing.


I anticipate FDA approval of psilocybin and MDMA within the next five years, and the UW Transdisciplinary Center for Research in Psychoactive Substances will help meet the need for more research into these applications, as well as others, that could dramatically improve patients’ lives.

Dr. Paul Hutson

Increasing Accessibility and Representation

Over the past two decades, just 2.5 percent of psychedelic-assisted psychotherapy study participants were African-American, 2.1 percent were Latinx and 4.6 percent were Indigenous. Without adequate racial and ethnic representation in clinical trials for new therapeutics, study findings may only be applicable to a narrow set of individuals, exacerbating a gap in mental health treatments. Finding ways to increase participation by BIPOC community members is central to the center’s mission.

“The Wisconsin Idea is really forefront, and that’s one of the reasons why I want to get broad representation on our executive and advisory committees, not only with Black and Hispanic populations but also with First Nations and in particular the tribes of the Northwoods,” said Hutson.

Indigenous cultures have long used psychoactive compounds like peyote and ayahuasca for healing and ceremony, and including these groups in clinical trials and strategy can yield new insights. Modern clinical trials have even borrowed best practices from Indigenous groups, such as the presence of a trained guide to stay with the patient throughout treatment.

Wenthur recently launched a study in collaboration with center members that’s geared toward understanding the basis for asymmetric participation and increasing representation by measuring the effects of increasing participant engagement in personalizing the study space and incorporating cultural competency training on study recruitment and results. “Closing health equity gaps must be a priority if we want to effectively address the heavy burden of mental health disorders present in America right now,” he said.

To help overcome barriers to recruitment and participation, the center will seek to add more study locations—in addition to the School’s facility—that will be easier for people to access. “It’s hard for people in some socioeconomic situations to access these trials,” said Hutson, citing work schedules, childcare and transportation as hurdles to the numerous appointments for preparatory sessions, treatments and follow-up visits. “More accessible study sites and more trained guides will help accelerate and augment this research on the UW–Madison campus, because those are the pinch points that are currently keeping us from moving forward.”

The new center is a partner of the School of Pharmacy’s Master’s of Science program in Psychoactive Pharmaceutical Investigation (PPI), which offers the first accredited U.S. degree focusing on the study and therapeutic development of psychedelic compounds and related psychoactive drugs. The center also is part of the Capstone Certificate in Psychoactive Pharmaceutical Investigation. “The center dovetails very nicely with our recently launched master’s program, particularly because the education needs to be supported by real-world expertise,” said Wenthur, who is the director of the PPI program. “The center and the master’s program work synergistically to provide an integrated vision for improving mental health.”

Hutson aims to position the UW–Madison campus as a training site, both for clinical facilitators and for students in the School’s PPI and capstone programs, which will continue to fuel future research. Although the National Institutes of Health awarded its first grant to medicinal psychedelic research just earlier in 2021, most studies into the therapeutic use of psychoactive substances rely on private donors or nonprofit organizations. To offer more researchers an opportunity to pursue and expand their projects, the center has created the Wisconsin Psychedelic Research and Education Fund, open to donors who want to maximize the impact of this emerging area of medicine. “Having this center gives us a home to engage in the future of scholarship, breaking down silos between traditional disciplines and asking tough questions at the interface of science, humanities, the arts and the human condition,” said Wenthur.

Reprinted with permission from the University of Wisconsin-Madison School of Pharmacy.