About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and ...
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
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...
Background: Treatment-resistant depression (TRD) affects a significant proportion of individuals with major depressive disorder and remains difficult to manage with conventional treatments. Psychedelic-assisted therapies and neuromodulation have emerged as innovative interventions targeting neurobiological mechanisms beyond traditional antidepressant approac...
The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will...
The past two decades have seen a remarkable renaissance in research on psychedelic drugs and ketamine. Following decades of regulatory restriction that severely limited, especially clinical research, a growing body of evidence has shown that psychedelics such as lysergic acid diethylamide and psilocybin can have long-lasting beneficial effects for treatment-...
Abstract Introduction Psychedelic use and interest in its therapeutic potential are rapidly increasing; yet its relationship with insomnia remains poorly understood. This study aims to estimate differences in insomnia severity by type of psychedelic consumed among a cohort of 18-to-35-year olds. Methods Data are from the Herbal Heart Study - Sleep Ancillary ...
Recreational psychedelic use is increasing, yet data on adverse events remains limited. This study characterized emergency department (ED) visits associated with recreational psychedelic use at UC San Diego Medical Center. We conducted a retrospective chart review of ED encounters (2010-2023). Cases were identified using ICD-10 hallucinogen-related codes and...
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ag...
In quite a few people worldwide, there are several mental disorders that prevent the brain from operating in the “proper” way, depression, anxiety, and post-traumatic stress disorder (PTSD) being among the most common. Luckily, there are several medications that are produced and used to treat these disorders, but some medications are hard to access, and othe...
AIMS: The recent regulatory approval of esketamine in adults heralded the renaissance of research into psychedelic compounds. However, the relevance of this resurgence for children and adolescents remains unclear. This review examines the rationale for investigating psychedelics in pediatric psychopharmacology. METHODS: We reviewed recent literature, regulat...
Abstract Background and aims Despite growing popularity and increasing legal access, psychedelic therapy remains financially inaccessible to many. This study was designed to test the feasibility of conducting group psilocybin therapy in low-income adults with depression in Oregon's regulated psilocybin program. Methods An open label, uncontrolled design was ...
BACKGROUND: Psychological distress is a common problem near the end of life, for which we lack effective, timely and scalable treatments. No previous study has assessed whether microdose psilocybin can improve symptoms in this population. AIM: To determine whether microdose psilocybin is safe, feasible and potentially efficacious in a palliative setting. DES...
Background: Psilocybin is a promising therapy for cancer-related distress, but existing individual treatment models are resource intensive. In this study, we designed and tested a group model of psilocybin therapy for people with metastatic cancer and cancer-related anxiety and depression. Method: Eligibility criteria included metastatic cancer, moderate-to-...
Psilocybe cubensis mushrooms are typically not consumed for their nutritional value. The main reason people ingest these mushrooms is for their psychoactive effects. Recently, there has been growing interest in the potential therapeutic applications of psilocybin-containing mushrooms in a range of psychiatric conditions, including depression, anxiety disorde...
Major depressive disorder (MDD), including treatment-resistant depression (TRD), is a highly prevalent psychiatric disorder. MDD is associated with severe suffering, burden and large economical costs. Although various conventional antidepressant treatments are available, a large portion of depressed people does not or not adequately respond to the first-line...
Background: Psilocybin therapy is an emerging treatment for cancer-related anxiety, depression, and existential distress. Most clinical trials to date have studied individual models of psilocybin therapy, but group models may offer increased access and benefits of community. Purpose: This technical report describes a group facilitation model developed for an...
BackgroundPalliative Care is concerned with relieving suffering and improving the quality of life of patients and their families. Currently, questions arise about how to provide patients with good end-of-life care. There has been increasing interest in the beneficial effects of using psilocybin-assisted therapy in patients with severe chronic illnesses near ...
“Magic mushrooms” produce a naturally occurring psychedelic compound called psilocybin. Public opinion surrounding psilocybin mushrooms generally holds that they are primarily used for recreational purposes, which may have contributed to their widespread prohibition in the United States. However, prior studies have demonstrated the potential efficacy of psil...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
