This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psiloc...
Humphry Osmond coined the term ‘psychedelic’ in 1956, conjoining ‘psyche’ for ‘soul’ and ‘delic’ from ‘dêlos’ for ‘to manifest’ or ‘illuminate.’ Soul-illumination is an adjective that describes a psychological state or process. However, Osmond’s intention was to use the adjective to name- not just a state- but a category of drug that can induce the subjectiv...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to ex...
This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will fo...
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participant...
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...
Recent clinical trial data suggests that ratings on depression scales are lowered after psilocybin therapy compared to placebo, though it is unclear what neuropsychological mechanisms underpin these effects. This study compared psilocybin, with an established antidepressant, escitalopram, to investigate whether there are shared or distinct effects on emotion...
Adolescent depression is a significant public health concern, yet treatment options remain limited, particularly due to age- and sex-related differences in antidepressant efficacy. This study explored for the first time the potential antidepressant-like response of psilocybin in adolescence by examining acute, repeated and persistent effects in Sprague-Dawle...
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-...
Psilocybin, an indoleamine alkaloid derived from various fungal species, is the subject of renewed, rigorous investigation for its therapeutic potential in psychiatry. This compound, a prodrug for the active metabolite psilocin, functions primarily as a partial agonist at the serotonin 2A (5-HT2A) receptor. Its administration within a structured psychotherap...
The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then b...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are: Does autobiographically salient music lead to stronger emotional responses to music, greater acute subjective e...
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes...
BackgroundMajor depressive disorder (MDD) is a significant public health concern, and current treatments often have limitations in effectiveness and adherence. Psilocybin, a psychedelic compound found in certain mushrooms, is being explored as a potential treatment for depression. It primarily acts through the serotonin 5-HT2A receptor but interacts with 5-H...
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and post...
Recent advances in psychedelic research have renewed interest in their therapeutic potential for psychiatric disorders characterized by cognitive and behavioral rigidity. This review examines the rationale for using serotonergic psychedelics-particularly 5-HT2A receptor agonists such as psilocybin-in the treatment of eating disorders (EDs), including anorexi...
Psychedelics, particularly psilocybin, have garnered significant attention as potential therapeutic tools for treating substance use disorders (SUDs), such as those related to alcohol, nicotine, heroin (an opioid), or cocaine. Traditional treatments often fall short, leading to high relapse rates and an urgent need for innovative approaches. This article exp...
Use of selective serotonin reuptake inhibitor (SSRI) antidepressants has been associated with reduced intensity of emotional experience. Conversely, some research has shown that use of psilocybin in patients with depression leads to an increase in responsiveness to emotional face stimuli, suggesting that the psychedelic generates a transient elevation in moo...
