This is a feasibility study to examine the use of use of Psilocybin (magic mushrooms) to alleviate pain in chronic neuropathic pain. While theoretical mechanisms demonstrate promise, there is no clinical evidence. This vacuum of clinical evidence has been occupied by a "psychedelic hype bubble" with media communications touting psychedelics as a 'miracle cur...
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 ...
Psilocybin, MDMA, and LSD have recently emerged as popular psychedelic substances for use in psychopharmacology in managing various disorders including treatment-resistant depression, PTSD, and anxiety. These substances mainly affect the serotonergic receptors that involve the regulation of consciousness, perceptions, and cognition. These unique alterations ...
IntroductionAs depression rates continue to rise globally, the need for more effective and innovative treatments has become increasingly urgent, highlighting the potential impact of psilocybin as a promising therapeutic option. However, to ensure its safe and effective integration into clinical practice, it is essential to establish robust safety parameters ...
Psychedelic therapy has the potential to become a revolutionary and transdiagnostic mental health treatment, yielding enduring benefits that are often attributed to the experiences that coincide with peak psychedelic effects. However, there may be an underrecognized temporal structure to this process that helps explain why psychedelic and related altered sta...
The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD). The study is a bi-centric, prospective, randomized, active placebo-controlled study investigating the effects of 25 mg and 5 mg (p.o.) psilocybin versus placebo (100 mg nicotinamide) in a psychothera...
Results of new psychedelic research aimed at patients with severe treatment resistant depression (TRD) found significant decreases in their depressive symptoms. Researchers of the open-label study also found significant safety and efficacy of synthetic psilocybin in TRD patients.
Although psychedelics were banned from medical research for about fifty years, recent early-phase studies indicate they may offer unique therapeutic benefits for various mental health and substance use disorders. When effective, psychedelic experiences often involve phenomena not typically observed in other medical or psychiatric interventions, such as a dim...
Anorexia nervosa (AN) is a psychiatric illness with high mortality rates and limited treatment outcomes. Psilocybin treatment (PT) has shown promise for various mental health indications and there is significant interest in exploring its potential for AN; however, studies to date are preliminary. Given the probable surge in psychedelic studies for AN, more i...
Current drug policy classifies psilocybin, a compound found in psychoactive mushrooms, as having high abuse potential while overlooking its therapeutic properties. We evaluated the risk of psilocybin mushrooms to Brazilian public health compared to other toxic agents and assessed the need for regulatory discussions. This retrospective cross-sectional study f...
The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX...
This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the f...
There is some evidence that the subjective effects of ketamine and other psychedelics like psilocybin are crucial for their therapeutic outcomes, such as treatment of depression or substance use disorder (SUD). We performed a meta-analysis and systematic review on the correlation of subjective symptoms and dissociation versus ketamine-induced therapeutic out...
Title: Use of psilocybin in the treatment of mental disorders: systematic review of clinical trials. Objective: To evaluate the high-impact evidence on the neurobiology, efficacy, safety, and feasibility of using psilocybin in the treatment of mental disorders such as depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (P...
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Abstract Effective interventions for neuropsychiatric disorders may work by rebalancing the brain’s functional hierarchical organization. Here we directly investigated the effects of two different serotonergic pharmacological interventions on functional brain hierarchy in major depressive disorder in a two-arm double-blind phase II randomized controlled tria...
e22518 Background: Classic psychedelics (Peyote, Psilocybin, Mescaline, and LSD) are re-emerging in the oncology toolbox. Peyote is the oldest known psychedelic, yet underexplored in clinical research. Preclinical studies suggest its extract stimulates lymphocyte proliferation, kills tumor cells, and may regulate sleep. This study aims to estimate the preval...