The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder. Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic str...
BACKGROUND: New legal frameworks for supervised psychedelic services are emerging, with Oregon and Colorado implementing programs to train and license psilocybin facilitators. This study describes Oregon's early psilocybin facilitator workforce and assesses state-approved training programs. METHODS: The Open Psychedelic Evaluation Nexus (OPEN) reviewed Orego...
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 ...
Background: Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. Objective: The current study sought expert recommendations from experienced psychedelic facilitators on what constitutes informed consent best practices for supervised psychedelic experiences across var...
Introduction: Cognitive flexibility is essential for behavioral adaptation in response to environmental changes and is impaired in various neuropsychiatric disorders. The serotonergic psychedelic psilocybin has shown potential in enhancing cognitive flexibility, although with mixed results. In this study, we investigated the effects of psilocybin on cognitiv...
A key distinction among clinical trials on psilocybin treatments, for example, those targeting depression, has been whether the psilocybin dosing session is combined with bona fide psychotherapy or with what is referred to as “psychological support” (1-3). The most developed model of psychological support is the Compass Psychological Support Model (CPSM; 1)....
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...
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...
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio...
The potential for psilocybin, and other psychedelic drugs, to fulfil a much needed and potentially transformative class of psychiatric treatments has garnered significant attention. Consequently, there has been a great deal of interest and investment in accelerating its development and potential implementation in routine clinical practice. However, the expan...
Psilocybin-assisted therapy (PAT) has gained recognition as an innovative intervention in hospice and palliative care, demonstrating potential in mitigating the psychological, spiritual, and existential distress experienced by patients with serious illnesses. This article explores the role of PAT within these care settings, emphasizing its influence on vario...
Abstract Background and Aims Networks of so-called underground, or illegal, psilocybin mushroom practitioners are popularly known to exist, though few systematic investigations of their practices have been conducted. We sought to uncover the experiences of a hidden community of psilocybin practitioners in order to inform scientific and policy dialogues about...
Physical touch is often included as a supportive or therapeutic tool in psychedelic-assisted therapy (PAT), involving instrumental forms of physical contact, supportive touch and somatic techniques. However, participants under the influence of psychedelics have reduced capacity to provide consent, are more suggestible and may experience and interpret therape...
As clinical trials for psychedelics move into phase III in the USA, Europe must address its lag in integrating professional education around psychedelic-assisted therapy (PAT) and supporting psychedelic drug research. This paper evaluates the necessary frameworks for implementing PAT in Germany, emphasizing the nation's potential leadership role within the E...
OBJECTIVES: Promising studies show that psilocybin-assisted therapy relieves existential distress in patients with serious illnesses, a difficult condition to treat with current treatment options. There is growing interest in this therapy in palliative care. Canada recently amended its laws to allow physicians to request psilocybin for end-of-life distress. ...
Introduction: Psilocybin, a tryptamine psychedelic, has been touted in the media both historically and recently as a potential game-changing mental health therapeutic. ClinicalTrials.gov has over one hundred and thirty psilocybin clinical trials listed covering the last twenty years. The single most important aspect of any therapeutic is to gain approval for...
This article assesses the right to privacy as a ground for challenging the constitutionality of the criminalisation of psilocybin mushrooms. In doing so, it discusses the right to privacy as found in section 14 of the Constitution of the Republic of South Africa, 1996 (Constitution). Drawing on Constitutional Court case law, the article argues that the right...
This article shows, from historical and ethnographic perspectives, how the city of Huautla de Jiménez in the Sierra Mazateca (Oaxaca, Mexico) became an emblematic place for the trade of psilocybin mushrooms. Sales to foreigners started to take place in the Sierra Mazateca during the 1950s, stimulated by botanical expeditions and by the collapse in coffee pri...
Cancer is not limited to the physical dimension, but it also affects the entire biopsychosocial context in which the patient is inserted, making him more susceptible to psychiatric disorders such as depression and anxiety. These often require pharmacological intervention, and the use of psilocybin, a substance found in mushroom species, is one of the alterna...
Serotonergic psychedelics such as psilocybin, lysergic acid diethylamide (LSD), or dimethyltryptamine (DMT), as well as psychoactive drugs that trigger phenomenologically- related experiences like 3,4-methylenedioxymethamphetamine (MDMA) and ketamine, belong to the most promising treatment approaches in contemporary psychiatry. Psychedelic-assisted psychothe...
