BACKGROUND: Chronic pain affects nearly one in five adults worldwide and remains a major healthcare burden due to its persistence, multidimensional impact, and resistance to conventional therapies. The opioid crisis has further highlighted the urgent need for safer and more effective alternatives. Psilocybin, a serotonergic psychedelic compound, has re-emerg...
Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to previous pharmacological or long-term psychological interventions. Hypothesis: Compared to baseline, the group that begins with psilocyb...
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...
First-hand experience with psychedelics may help clinicians develop skills and knowledge needed to work with the profound changes to conscious awareness occasioned by psychedelics. However, the topic remains contentious and underexplored. In this world-first study, we investigated the utility of psilocybin experiential therapist training in a sample of 14 me...
Background: Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental hea...
Serotonergic psychedelics and 3,4-methylendioxtmethamphetamine (MDMA) are promising treatments for mental disorders with a continuously evolving evidence base. We searched Pubmed/Scopus/clinical trial registries up to 08july2025 for double-blind randomized controlled trials (RCTs) testing MDMA or serotonergic psychedelics in patients with mental disorders. P...
This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin...
OBJECTIVES: To assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy (PAT) for demoralisation in terminally ill patients receiving home hospice care. METHODS: In this open-label pilot trial, 4607 home hospice patients at a large community hospice were screened over 22 months; 66 were approached, 15 enrolled and 10 received ps...
• Ketamine and psilocybin show promise in athlete recovery and pain management. • Psychedelics may enhance resilience, mood, and cognitive flexibility in sports. • Growing athlete use raises concerns for safety and anti-doping regulation. • Evidence on long-term effects with exercise remains scarce, urging research.
After many years of stigma and neglect, there is a resurgence of interest in the therapeutic use of psychedelic drugs. Anecdotal and evidence-based reports indicate psychedelics as a possible treatment for depression, anxiety, PTSD, substance abuse, and other disorders resistant to conventional medical interventions. The available data, however, are limited ...
Chronic pain affects millions of people and remains one of the greatest clinical challenges due to limited response to conventional therapies. Psilocybin, a psychedelic found in mushrooms of the Psilocybe genus, has sparked interest due to its potential to modulate serotonergic receptors and promote neuroplasticity, suggesting analgesic and psychotherapeutic...
IntroductionBipolar disorder (BD) is a severe and persistent mental disorder characterized by recurrent mood episodes, with BD depression accounting for most of the illness burden. Although the mainstay treatment of BD consists of pharmacotherapy with mood stabilizers and atypical antipsychotics, a large proportion of patients with BD depression do not respo...
BACKGROUND: Individuals with advanced cancer often experience high levels of distress for which there are few standardized treatment approaches. Our multidisciplinary team has combined existing evidence-based approaches into Psilocybin-assisted Existential, Attachment, and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted p...
Psilocybin, a psychedelic prodrug, has gained renewed interest for its potential to treat various psychiatric disorders, including depression, anxiety, and substance use disorders. While promising, concerns remain regarding its safety profile and the management of potential adverse events (AEs). This systematic review aimed to evaluate the incidence, nature,...
Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-...
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patient...
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depre...
The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose i...
A crystalline cocrystal of psilocin and psilocybin enhances exposure, neuroplasticity biomarkers, and functional activity, while adjunctive atypical antipsychotics modulate serotonergic signaling to mitigate 5-HT2B-linked safety concerns. Together, these inventions advance formulation, mechanistic selectivity, and translational biomarkersoffering a chemistr...
The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive...
