Background: Psilocybin has demonstrated promising clinical outcomes for nicotine and alcohol use disorders, yet its potential clinical utility in the treatment of opioid use disorder (OUD) remains unreported in modern literature. This technical report presents methodological considerations and preliminary data from a safety-feasibility trial examining the in...
A single 25-mg dose of psilocybin administered with psychological support led to significant and sustained improvement in depressive symptoms compared with placebo in a Phase 2 study of patients with major depressive disorder. A higher number of adverse events occurred in the psilocybin group, but no serious treatment-emergent adverse events were reported. S...
This paper explores Christian responses to religious and spiritual experiences (RSEs) associated with psilocybin-assisted therapy (PAT). It addresses the challenges of defining and understanding spiritual and religious experiences and examines the theological implications of PAT-induced RSEs. It highlights the growing acceptance of PAT as a therapeutic appro...
Research into the use of psilocybin for the treatment of psychiatric disorders is a growing field. Nevertheless, robust brain-behavior relationships linking psilocybin-induced brain changes to subjective drug-induced effects have not been established. Furthermore, it is unclear if the acute neural effects are dependent on individual heterogeneity in baseline...
Background Psilocybin has been studied for its potential therapeutic benefits, particularly for the treatment of psychiatric disorders such as anxiety, depression, and obsessive-compulsive disorder. While more research is needed as psilocybin-assisted therapy becomes more prevalent, future pharmacists will probably be involved at some level. At present, phar...
Patients characterized by stress-related disorders such as depression display elevated circulating concentrations of pro-inflammatory cytokines and a hyperactive HPA axis. Psychedelics are demonstrating promising results in treatment of such disorders, however the mechanisms of their therapeutic effects are still unknown. To date the evidence of acute and pe...
Background: Recent studies suggest that one to two administrations of psilocybin have acute antidepressant effects for people with major depressive disorder. These data on psilocybin have generated considerable enthusiasm, but little empirical attention has been paid to the therapy that adjoins psilocybin treatment (psychedelic-assisted therapy, or PAT). Mat...
Importance: Psilocybin shows promise as a treatment for major depressive disorder (MDD). Objective: To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. Design, Setting, and Participants: In this phase 2 trial conducted between December 2019 and June 2022 at 11 research si...
Rationale: N-methyl-D-aspartate receptor-mediated dissociatives and serotonergic hallucinogens are being increasingly used in therapeutic interventions that involve nonordinary states of consciousness and may represent a unique mental health paradigm wherein pharmacologically induced experiences are conducive to psychological well-being. Objective: The aim o...
Psilocybin and lysergic acid diethylamide (LSD) experiences can range from very positive to highly challenging (e.g., fear, grief, and paranoia). These challenging experiences contribute to hesitancy toward psychedelic-assisted psychotherapy among health care providers and patients. Co-use of 3,4-Methylenedioxy methamphetamine (MDMA) with psilocybin/LSD anec...
Background: Psilocybin and psychedelic-assisted therapy (PAT) have gained renewed interest due to recent findings that PAT can enhance therapeutic outcomes. In 2019, the U.S. Food & Drug Administration (FDA) approved breakthrough therapy status to psilocybin for the treatment of depression, but PAT has yet to be approved as a therapeutic treatment for mental...
The pharmacological treatment of depression consists of taking antidepressant drugs for prolonged periods; its modest therapeutic effect can often be associated with significant adverse effects, while its discontinuation can lead to relapses. Psilocybin is today a novel and breakthrough therapy for major depression. It is a natural alkaloid in Psilocybe mush...
This perspective paper explores the choice of psychotherapy for psilocybin-assisted psychotherapy for treatment-resistant depression. There is evidence to support the use of some psychotherapies in treating 'treatment-resistant' depression, and emerging evidence for the efficacy of psilocybin. The next step which is the focus of this paper is to identify psy...
Context: Measuring therapeutic connection during psilocybin-assisted therapy is essential to understand underlying mechanisms, inform training, and guide quality improvement. Purpose: To evaluate the feasibility of directly observing indicators of therapeutic connection during psilocybin administration encounters. Methods: We evaluated audio and video data f...
Psilocybin is being investigated as a treatment in adults with treatment-resistant depression (TRD). Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, exploratory, international, fixed-dose, o...
BACKGROUND: Randomised controlled trials (RCTs) of psilocybin have reported large antidepressant effects in adults with major depressive disorder and treatment-resistant depression (TRD). Given psilocybin's psychedelic effects, all published studies have included psychological support. These effects depend on serotonin 2A (5-HT2A) receptor activation, which ...
BACKGROUND: Evidence suggests that serotonergic psychedelics (e.g. psilocybin), have rapid-acting and long-lasting antidepressant effects after a single dose. However, the mechanism underlying these effects remain unclear. One proposed mechanism is that these drugs promote neuroplasticity. However, this has not been conclusively demonstrated in humans. AIMS:...
