This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in...
Abstract Introduction Post-treatment Lyme Disease (PTLD) is a post-infectious syndrome characterized by fatigue, hypersomnia, sleep-disturbance, musculoskeletal pain and/or cognitive difficulties. As part of an open-label pilot study of psilocybin-assisted treatment for PTLD, we explored potential for psilocybin-assisted treatment to remedy sleep-related dis...
Abstract Rationale The elderly population is rapidly growing. Overwhelming epidemiologic data has demonstrated worse health outcomes with increasing age for a multitude of lung diseases (COVID being one of numerous examples). There is an increasingly urgent need for a more complete understanding of the molecular pathways and biological processes underlying a...
Depression is one of the most common mental health challenges people face today. It goes beyond just feeling sad - it shapes the way a person thinks, behaves, and experiences the world around them. The persistent low mood, the fading interest in things that once brought joy, the fog that makes even simple decisions feel overwhelming - all of it quietly chips...
Psychedelic-assisted therapy (PAT) has demonstrated substantial efficacy across a range of mental disorders. However, heterogeneity between patients confers differential responsiveness. This systematic review aims to explore factors which may predict therapeutic responses to PAT. A systematic search was performed from inception through to March 2024 and stud...
While psychedelics have shown initial promise in the treatment of migraine, experimental studies have relied on small and homogenous samples, which limit the reliability and generalizability of findings. These limitations underscore the complementary value of other research designs that leverage larger and more representative samples. This cross-sectional st...
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two p...
Psychedelic drugs are serotonergic hallucinogens that can be divided into two types: naturally occurring (psilocybin, psilocin, and N,N-dimethyltryptamine) and synthetic (LSD, MDMA, 2,5-dimethoxy-4-iodoamphetamine, and ketamine). Psychedelics generally work on 5-hydroxytryptamine receptors and might be useful in cognitive enhancement, brain connectivity, neu...
Chronic pain states remain challenging to control with current drug therapies. Here, we demonstrate that a single dose of psilocybin produces a sustained anti-nociceptive effect in chronic neuropathic pain models in male and female mice, mediated primarily by 5-HT2A receptors. Critically, psilocybin significantly potentiates the analgesic efficacy of gabapen...
Reliable documentation of the traditional use of serotonergic psychedelics has long been confined to the Americas. Prevailing narratives often overstate the global prevalence and uniformity of traditional psychedelic use, extrapolating from a limited set of well-documented cases. Here, we report evidence of psilocybin mushroom use among Basotho traditional h...
Abstract Rationale and Objectives: Polysubstance use involving psychostimulants and opioids is increasingly prevalent and associated with elevated overdose risk, relapse vulnerability, and poor treatment outcomes. However, the neurobehavioral consequences of opioid-stimulant use remain poorly understood. We evaluated whether repeated methamphetamine-fentanyl...
Autism Spectrum Disorder (ASD) is characterized by persistent social-communication deficits, cognitive rigidity, and atypical sensory processing. Current pharmacological treatments, including risperidone and aripiprazole, provide only limited symptomatic relief and do not address the underlying neurobiological mechanisms. Converging evidence implicates dysre...
This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder. The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psil...
One hundred 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 wil...
The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how peop...
