This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD...
PsiConnect is a large-scale neuroimaging study designed to investigate context-dependent neural and subjective effects of psilocybin using multimodal neuroimaging. It combines functional, structural, and diffusion-weighted MRI with EEG to examine brain activity in 62 participants before and after a 19 mg dose of psilocybin. The design includes resting-state ...
Mescaline, a 5-HT2A agonist psychedelic used ceremonially for millennia, lacks neuroimaging characterization due to its Schedule 1 status. Using pharmacological and resting-state fMRI in awake rats, we report mescaline's first comprehensive neurobiological profile. Acutely, mescaline produced cerebellar-selective BOLD suppression, suggesting functional disco...
Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants. In clinical trials, psilocybin has shown p...
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocy...
Recent studies show that psychedelics such as psilocybin and LSD can reliably occasion spiritual or “mystical-like” experiences under supportive conditions, and the spiritual dimension of these experiences may contribute to their reported mental health benefits. Scholars have begun exploring how such experiences might relate to spiritual growth within Christ...
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological m...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, f...
Psilocybin has emerged as a promising therapeutic agent for psychiatric disorders characterised by cognitive rigidity and disrupted reward processing, including anorexia nervosa. While its pro-cognitive effects have been mechanistically probed almost exclusively through serotonin receptor subtype antagonism, the downstream contributions of dopaminergic syste...
Recent literature suggests potential associations between hallucinogen use and valvular heart disease (VHD) due to prolonged activation of serotonin 5-HT2B receptors, which may lead to valvular fibrosis - a condition also linked to drugs including fenfluramine and pergolide. Despite these concerns, epidemiological studies exploring this association are lacki...
Importance: Psilocybin has been proposed as a rapid-acting antidepressant (onset 6 weeks), but evidence from randomized clinical trials remains limited, particularly in the broader major depressive disorder (MDD) population. Objective: To assess short-term and long-term antidepressant effects of psilocybin therapy in patients with MDD. Design, Setting, and P...
This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings o...
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM1: To compare the e...
Background: Social anxiety disorder is a chronic and disabling condition with limited response to standard therapies. Low-dose psilocybin may enhance the effectiveness of exposure-based treatments by modulating neural circuits associated with fear and avoidance. Virtual reality exposure therapy offers a controlled and individualized platform for intervention...
PURPOSE OF REVIEW: There is growing evidence that psychedelics and associated treatment modalities may offer therapeutic benefits across a range of psychiatric conditions. Anorexia nervosa (AN), a serious and often treatment-resistant illness associated with significant morbidity and mortality, is one such condition for which psilocybin-assisted therapy (PAT...
Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. The current study sought expert recommendations on informed consent challenges, best practices and recommendations for supervised psilocybin experiences across various settings. Participants with psilocybin content...
Importance: The Oregon Psilocybin Services (OPS) program is the first statewide, regulated framework for legal psilocybin in the U.S. Analyzing inaugural-year utilization and safety is essential for informing policy and equity monitoring. Methods: We conducted a descriptive analysis of statewide aggregate data from the OPS Public Dashboard (January 1-Decembe...
