Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation...
Psilocybin, a serotonergic psychedelic, may have therapeutic benefits for Substance Use Disorders (SUDs), but its overall efficacy and safety remain uncertain. This systematic review assessed the safety and efficacy of psilocybin for SUDs through a systematic database search conducted via OVID on May 22, 2024, and summarized 26 ongoing clinical trials regist...
IntroductionAlthough long known for their psychoactive effects, psychedelic drugs have only recently been investigated for medicinal use. Psilocybin has attracted the greatest interest with studies suggesting that it may be a useful agent in psychiatry and in palliative care.Areas coveredClinical trials that included psilocybin were searched in PubMed, Embas...
Psilocybin, a naturally occurring psychedelic compound, has garnered renewed scientific interest for its potential in treating psychiatric and neurological disorders. This review systematically examines the latest research on psilocybin's pharmacokinetics, pharmacodynamics, clinical efficacy, and safety profile. Emerging evidence supports its efficacy in con...
Advanced clinical trials investigate the Psilocybe magic mushroom natural product psilocybin as a treatment against major depressive disorder. Currently, synthetic material is used to meet the demand for legitimate pharmaceutical purposes. Here, we report an in vitro approach to biocatalytically produce psilocybin on a solid-phase matrix charged with five co...
Psychiatric disorders are marked by habitual patterns of thought, emotion, and behavior, and many mental health disorders are resistant to standard treatments (1)(2)(3)(4). For example, symptoms of major depressive disorder include ruminative negative thoughts, pervasive sadness, and lack of goaldirected behavior (5)(6)(7). Similarly, many anxiety and trauma...
To examine the relationship of acute psychedelic effects and measures of mental health with headache frequency in clinical trials of psilocybin in migraine and cluster headache.
Clinical trials using full doses of psychedelics have provided preliminary evidence supporting their safety and efficacy in treating a variety of physical and psychological conditions. Anecdotal reports indicate that even very small amounts of these substances may provide therapeutic benefits, though robust clinical studies are still needed. This chapter rev...
Introduction Selective reporting of outcome data (SOR) refers to trialists selecting results for publication based on the results of a subset of the initially measured outcomes. SOR for specific, potentially very profitable, treatments, particularly in key junctures such as in the period leading to or immediately preceding approval, has not been examined. Ob...
Importance: There is growing societal interest in and use of psilocybin. While psilocybin in Canada is illegal outside of clinical trials, there have been anecdotal reports of increasing access via unregulated online purchases and retail dispensaries. Objective: To describe access to and the characteristics of psilocybin dispensaries across Canada and the he...
INTRODUCTION: Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-A...
ObjectivesMood disorders and existential distress impact those with cancer or a serious illness at higher rates than the general population. There have been limited pharmacological advances in recent years, and available psychological interventions vary in degree of impact and durability as a treatment modality in this population. A recent renaissance in psy...
Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approx...
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 ...
Psychedelics have recently gained attention as potential therapeutic agents for treating patients with substance use disorders, with studies showing promise of psychedelics for reducing substance use and cravings. Despite a limited number of well-controlled modern trials examining psilocybin treatment for alcohol or tobacco use disorder, the available eviden...
The growing interest in psychedelic-assisted therapy (PAT) for treating psychiatric disorders such as treatment-resistant depression, PTSD, and anxiety has led to an increasing demand for specialized training. In Switzerland, MDMA, psilocybin, and LSD are applied in the framework of limited medical use as exceptional treatment options since 2014. The Swiss M...
Brain aging (BA) processes are complex, often affect multiple systems, and frequently lead to cognitive decline and increased susceptibility to insults. BA appears to be a primary risk for the development of many prominent neurodegenerative pathologies. The US Census Bureau predicts that the aging population (65+) will represent a greater proportion of the U...
PurposeTo evaluate the current level of evidence for the use of psychedelics for the management of cancer pain and associated psychological distress.ContentPain is a common symptom of cancer and treatment. However, there are high rates of undertreatment of cancer pain due to the complex underlying biology of the condition, and potentially due to a decrease i...
Psychedelic-assisted therapy (PAT) is an emerging treatment approach that often combines pharmacotherapeutic dosing sessions with more traditional psychotherapy. Despite limited formal regulatory approval, treatment seekers can currently access PAT through a variety of avenues, including ketamine treatment centers and “supported adult use” psilocybin centers...
Psychedelic-assisted therapy (PAT) is an emerging treatment approach that often combines pharmacotherapeutic dosing sessions with more traditional psychotherapy. Despite limited formal regulatory approval, treatment seekers can currently access PAT through a variety of avenues, including ketamine treatment centers and “supported adult use” psilocybin centers...
