Advancing research in the emerging field of psychedelic compounds
Members of the University of Wisconsin–Madison Transdisciplinary Center for Research in Psychoactive Substances are engaged in research that cuts across multiple disciplines and engages with science and society. Center members work together and individually to better understand the psychoactive substances in the lab, clinical settings, and in within the humanities.
Members of the Center are engaged in Phase 1-3 clinical trials of psychedelic and psychoactive compounds. Some of these trials are part of multi-site Phase 2 and 3 trials making their way toward New Drug Applications with the FDA. Other early stage studies are exploratory, often mechanistic studies of these agents in humans as well as animal models.
Members also currently engage in cultural, legal, economic, and historical research and this body of scholarship comes from departments and divisions across the UW campus.
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Active Clinical Studies
Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)
Sponsor: UW Madison Internal Donors
Goal: The objectives of this study are to investigate the feasibility, tolerability, and preliminary efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks.
Contact: brave@psychiatry.wisc.edu; Phone: (608) 265-3610
Co-PI’s:
– Ryan Herringa, MD, PhD
– Christopher Nicholas, PhD
Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression
Sponsor: Beckley Psytech Ltd
Goal: This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).
Contact: bpl003wi@fammed.wisc.edu
PI: Randall Brown, MD, PhD
Role of Experience Versus Recall and Plasticity in Psilocybin’s Long-Term Behavioral Effects – Follow-Up Study (The RECAP 2 Study)
Sponsor: UW Madison Internal Donors
Goal: The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain’s ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.
Contact: Coming soon in 2025
PI: Charles Raison, MD
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin
Sponsor: UW Madison and Tiny Blue Dot Foundation
Goal: This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.
Contact: https://raisonresearch.psychiatry.wisc.edu/current-studies/
PI: Charles Raison, MD
CoPE: Consciousness and Psilocybin Effects on Well-Being (IIT)
Sponsor: Tiny Blue Dot Foundation
Goal: Identify a method to deliver psilocybin intravenously during sleep in health young adults, and assess the effects on EEG. If interested in participating, complete our REDCap survey to see if you are eligible and be contacted by the study team: https://redcap.link/l2j6siz6
For any questions, contact the study team at: info@clinicaltrials.wisc.edu
PI: Charles Raison, MD
HOUDI-1: Phase I Safety Trial of Psilocybin in Patients with Opioid Use Disorder (IIT)
Sponsor: Heffter Research Institute
Goal: Conduct a single arm feasibility study of 2 guided psilocybin sessions in addition to opioid agonist therapy (OAT) with buprenorphine/naloxone in a sample of 10 adult subjects with OUDs.
PI: Randall Brown, MD, PhD
PRIMUS: Phase I Safety Trial of Psilocybin in Patients with Methamphetamine Use Disorder (IIT)
Sponsor: pending
Goal: Conduct a single arm feasibility study of 2 guided psilocybin sessions in a sample of 10 adult subjects with Methamphetamine Use Disorder
Status: Recruiting
PI: Christopher Nicholas, PhD
POIESIS: Psychedelic Outcomes; Interaction of Environment, Self-Identity, and Success
Sponsor: Wisconsin Alumni Research Foundation (WARF)
Goal: To understand whether racial and ethnic self-identities are predictive of reactions to the psychedelic dosing environment and to assess whether the inclusion of culturally-adaptive features increase racial and ethnic minority participation and improve experience in psychedelic research studies.
PI: Cody Wenthur, PharmD, PhD
Previous Clinical Studies
RECAP-Pilot: Phase I Trial Psilocybin with Midazolam (IIT)
Sponsor: Michael and Mary Shannon
Goal: Under the supervision of an anesthesiologist, administer boluses of midazolam to normal volunteers who have also received psilocybin to determine the safety of the combination. The follow-up study will use a similar dual regimen to assess whether the ability to recall the psychedelic experience is requisite for the anti-depressive effects reported for psilocybin.
PI: Christopher Nicholas, PhD
MAPP2: MDMA as an Adjunct for the Treatment of PTSD (Phase 3 registration trial)
Sponsor: Multidisciplinary Association for Psychedelic Studies (MAPS)
Goal: This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy versus psychotherapy with placebo in participants diagnosed with severe post-traumatic stress disorder (PTSD).
co-PIs: Christopher Nicholas, PhD and Randall Brown, MD, PhD
PSIL201: Psilocybin as Treatment for Major Depressive Disorder (Phase 2 registration trial)
Sponsor: Usona Institute
Goal: The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 8 post-dose.
PI: Randall Brown, MD, PhD
Pre-Clinical Biomedical Research
Deconvoluting Polypharmacologic Contributions of Rapidly-Acting Antidepressants
Sponsor: National Institute of Mental Health (R01MH122742)
Goal: To track emergent circuit- and behavioral-level effects arising from the simultaneous actions of ketamine and hydroxynorketamine as a means to develop improved multi-target antidepressants with rapid mechanisms of action.
PI: Cody Wenthur, PharmD, PhD
Pro-Neuroplastic Mechanisms Underlying Therapeutic Actions of Psychoactive Agents
Goal: To measure and manipulate acute stress-associated hormonal release arising from psychedelic administration in animal models across different environmental contexts, and assesses the impact of this stress associated signaling on both functional changes in neuronal connectivity and behavioral measures of anxiety, learning, and reward.
PIs: Cody Wenthur, PharmD, PhD and Matthew Banks, PhD
Psychedelic Scholarship - History and Humanities
Accessing the History of Health, Pharmacy, and Medicines at UWSoP/AIHP (2022-2025)
Sponsor: National Endowment for the Humanities (NEH)
Goal: The goal of this three-year NEH-funded project is to improve the description of and the accessibility to the Kremers Reference Files historical collection, the AIHP/UWSoP ephemera collection, and the AIHP/UWSoP artifact collection. These activities will allow great access to psychoactive historical materials.
UW Participant: Lucas Richert
Contested Cannabis: A History of Marijuana in Wisconsin and the Wider World
Sponsor: Wisconsin Humanities (2020-2021)
Goal: This project developed an online digital exhibit that explores and explains the history of cannabis, hemp, and marijuana in Wisconsin and across the United States through five themes: Taxonomy; Hemp Agriculture; Pharmacy & Medicine; Propaganda & Education; and De/Criminalization.
UW Participant: Lucas Richert, Gabriel Carter
Art, Music, and Land Activism Across Psychedelic Cultures: From the Huichol People (Wixaritari) to Clinical Trials
Sponsor: Arts Alliance at Research Universities
Goal: This series of talks held in October 2020 offered a nuanced picture of the interconnected issues surrounding psychedelic ritual/therapy, art/music, and land/equity, in the context of both research universities and indigenous cultural practices. The series of talks began by highlighting the relationship between the Huichol (Wixáritari) peyote ritual, their art and music traditions, and the fight for land and equity to sustain their culture. The second portion of the session featured talks focusing on dimensions of art/music and land/equity within the context of psychedelic clinical trials.
UW Speakers: Amanda Pratt, Anny Ortiz, Alberto Vargas, Cody Wenthur
Cannabis: Global Histories
Sponsor: Wellcome Trust (2018-2021)
Goal: This network gathered together authors and scholars from the new wave of cannabis histories that has emerged in recent decades. The result was a landmark and transdisciplinary volume.
UW Participant: Lucas Richert
Pharmaceutical Development Resources
- The University of Wisconsin–Madison offers formulation development and validation services through the Zeeh Pharmaceutical Experiment Station.
- UW Madison offers multiple dosing suites for early and late-stage clinical testing of psychoactive compounds. This includes rooms in the Clinical Research Unit at UW Health Hospital, with nursing and medical staff experienced in Phase I clinical trials that include advanced services such as pharmacokinetic sampling and clinical monitoring as appropriate.
- Study monitoring and auditing services are available through the UW–Madison CTSA, as well as an in-house Data Safety and Monitoring Committee.Contact:
Paul Hutson, PharmD
TCRPS Director
Email Paul
(608) 263-2496
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Help our team of scientists, clinicians, and teachers advance treatment of PTSD and depression with psychoactive substances.
Interested in Participating in a Clinical Study?
At this time, we do not have active studies directed toward the treatment of adult depression or adult post-traumatic stress disorder (PTSD). Please note our Active Clinical Studies are listed in the tabs to the left.
Other sites that may be testing psychoactive-assisted therapy for depression, anxiety, or PTSD may be found at clinicaltrials.gov.
If you are interested in participating in a clinical trial of psilocybin for the treatment of opioid use disorder or methamphetamine use disorder, please send an email indicating your interest to: protea.research@mailplus.wisc.edu.
A new clinical study of administering IV psilocybin to healthy young adults while asleep (the CoPE trial) has recently been opened. Please note the contact information under the Active Clinical Studies tab.