Background: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). However, the effects of open-label administration following blinded treatment are unclear. Here, we present safety and efficacy data from an open-label extension of a Phase II RCT (NCT02061293) examining PAT for AUD. Methods:...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of mo...
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people ...
Recent years have witnessed a rise in microdosing psilocybin. Individuals who engage in this practice report diverse motivations for use which suggests heterogeneity among microdosers. However, research to date has taken a monolithic approach to the examination of microdosers which may overlook potentially important differences. To address this limitation, w...
Introduction: Major depressive disorder (MDD) affects over 21 million adults in the U.S (NIMH, 2023) and remains a significant public health challenge. Despite the effectiveness of traditional medications, 30% of patients remains resistant. Little is known about the beliefs individuals hold regarding novel treatments, such as psilocybin and the motivations b...
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...
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...
A recent randomized, double-blind, placebo-controlled, parallel-group trial (NCT02061293) found that psilocybin-assisted therapy significantly improved drinking outcomes compared to an active placebo in adults with alcohol use disorder (AUD). In this secondary analysis, we assessed whether psilocybin-assisted therapy improved self-compassion and whether thes...
A recent randomized, double-blind, placebo-controlled, parallel-group trial (NCT02061293) found that psilocybin-assisted therapy significantly improved drinking outcomes compared to an active placebo in adults with alcohol use disorder (AUD). In this secondary analysis, we assessed whether psilocybin-assisted therapy improved self-compassion and whether thes...
OBJECTIVE: To compare changes in depression, anxiety, and suicidality symptoms after a single 25 mg oral dose of psilocybin between treatment-resistant depression participants not on antidepressants at screening to participants that discontinued antidepressant medications leading up to receiving psilocybin-assisted psychotherapy (PAP). METHODS: Participants ...
Abstract Background: Due to increasing cultural and legal acceptance of psychedelics, there is a need to understand their potential influence on formal mental health care. This paper examines the connection between psychedelics, distress, and treatment utilization. Are psychedelic users less likely to use formal mental health care? Methods This study tests t...
Previous research has proposed that there may be potential synergies between psychedelic and meditation interventions, but there are still knowledge gaps that merit further investigation. Using a longitudinal observational research design with samples representative of the US and UK adult population with regard to sex, age, and ethnicity ( = 9732), we invest...
The COVID-19 pandemic has resulted in a surge in depression cases, a pervasive and debilitating mental illness1. This trend is evident in the increased prescriptions for antidepressants. Depression is a chronic condition that affects a significant proportion of the global population, with ~280 million people, or about 3.8%, suffering from it. As a result, it...
In medicine, psychedelics were initially considered as a tool for clinicians to understand psychotic states. Based on the presented case data, a reversal of that concept is proposed: psychedelics could be conceptualized as a tool for people chronically anxious and depressed since early childhood to understand ordinary states of mind (e.g. calmness, hopefulne...
In medicine, psychedelics were initially considered as a tool for clinicians to understand psychotic states. Based on the presented case data, a reversal of that concept is proposed: psychedelics could be conceptualized as a tool for people chronically anxious and depressed since early childhood to understand ordinary states of mind (e.g. calmness, hopefulne...
Humans have collected and used hallucinogenic mushrooms for ethnic medicinal, recreational, and religious purposes since before recorded history. Currently, the use of these mushrooms is illegal in most countries, but where their use is legal they are applied as self medication. Psilocybin and psilocin, two psychoactive alkaloids, are naturally synthesized b...
Mental health disorders such as depression and anxiety are major contributors to the overall global health burden. COVID-19 has further aggravated mental health disorders and also increased substance abuse due to lockdowns1. The Global Burden of Disease reported that the pandemic has led to a 27.6% increase in cases of major depressive disorder (MDD) and a 2...
The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week. Subjects will maintain a headache diary prior to, during, and after the administrations in order to document headache frequency, intensity and duration. Subjects w...
Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study Major depressive disorder (MDD) is one of the world's greatest contributor to the global burden of disease and MDD affects around 17% of the Swiss population (Tomonaga et al. 2013). It i...
