Our Studies

Randomized Clinical Trial of Psilocybin for Depression (Usona Institute)

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.

Eighty participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo.

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Safety and Efficacy of Psilocybin Treatment for Depression in Bipolar 2 Disorder

Depression in bipolar disorder is associated with significant functional impairment, psychosocial disability, and risk for suicide. Despite this morbidity, there are very few effective treatments for depression in this population. While psilocybin has been shown to be a promising treatment for unipolar depression, all modern clinical trials have excluded people with bipolar disorder. We plan to assess the safety and preliminary efficacy of psilocybin therapy for the treatment of depression in individuals with bipolar 2 disorder using an open-label study design. The study will begin in ~June 2021.

A Mixed-Methods Study of Psilocybin Use Among Adults with Bipolar Affective Disorder

Despite a desperate clinical need for new effective treatments for depression in bipolar disorder, this population has been excluded from all modern clinical psychedelic therapy trials. To assess the relative safety and feasibility of future clinical psilocybin trials in this group, our team is conducting a mixed-methods study of historical psilocybin use patterns among adults with bipolar affective disorder. Our aim is to learn this population’s reasons for using psilocybin mushrooms, the circumstances in which they are using psilocybin mushrooms, their risk management strategies (e.g., medication management, sleep hygiene) surrounding psilocybin mushroom use, and the outcomes (both positive and negative) of using psilocybin-containing mushrooms. After completing the international survey portion of this study in January 2021, our team is expected to complete the follow-up qualitative interview portion by May 2021. Data from these studies should be ready for publication in early 2022.

Psilocybin Therapy for Depression and Anxiety in Parkinson’s Disease: A Pilot Study

Parkinson’s Disease (PD) is a devastating neurodegenerative disorder with growing impact worldwide. Depression and anxiety are common in PD and linked to poor quality of life and high health care costs. Unfortunately, treatment options for patients are limited. Though previous studies have found that psilocybin may be helpful for people with depression and anxiety, all of these studies have excluded patients with PD or any other neurodegenerative disorder. As a result, we lack critical information about the safety, tolerability, and feasibility of this treatment for people living with PD. In this study, our goal is to fill that gap. If successful, this project will lay the groundwork for a larger randomized placebo-controlled study of psilocybin therapy for treating PD-associated depression and anxiety. We expect to start recruitment in May 2021.

 


 

Effects of Psilocybin Therapy on Sleep and Thermoregulation

We are looking at the effects of psilocybin therapy on two aspects of physiological function: 1) sleep, and 2) thermoregulation. These functions can be disrupted in multiple disorders that involve mood symptoms (including depression, chronic pain, and Parkinson's Disease). For example, people with depressed mood can have impaired thermoregulatory cooling capacity, meaning that they are not as able to sweat in order to cool their bodies down. People with chronic pain can experience disruptions in their sleep after pain-induced awakenings. Participants in our clinical psilocybin trials will have the option of using the Oura Ring, a wearable technology that measures heart rate, skin temperature, respiratory rate, physical activity, and sleep throughout the day and night. Data gathered with the device can help us understand whether psilocybin therapy impacts sleep and/or thermoregulatory capacity. By quantifying changes in key metrics over the course of multiple trials, we hope to gain insights about the physiological dysregulations that underlie mood symptoms as well as the mechanisms of psilocybin's effects on those symptoms. This study is estimated to begin in April 2021.

Elucidating the Mechanisms of Psilocybin’s Antidepressant Effects

Depression affects more than 300 million people worldwide and current treatments are inadequate. Psilocybin offers a radically new approach that may be a breakthrough for the field, especially when other treatment options have failed. Still, the mechanisms by which psilocybin yields rapid, robust, and long-lasting improvements in depressive symptoms remains largely unknown. By examining psilocybin’s effects in both rat models of depression and depressed individuals, we aim to elucidate the behavioral, neurocircuit, neurophysiological, and cellular/molecular mechanisms of psilocybin’s antidepressant effects. This study is estimated to start in April 2021.

 


 

Randomized Clinical Trial of Psilocybin for Chronic Low Back Pain 

The primary purpose of this study is to examine the preliminary efficacy of psilocybin therapy for people with chronic low back pain. Chronic low back pain is the most common musculoskeletal problem and is a leading cause of years lived with disability. There is an urgent need for safe and effective treatments for chronic low back pain. This study examines the effects of a single dose of psilocybin in combination with therapeutic preparation and integration sessions. We hope psilocybin therapy will lead to improvements in pain interference and other cognitive and affective symptoms related to chronic low back pain. This study is estimated to start in June of 2021.