This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them. The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg o...
Background: Despite significant advancements in the treatment of depression, challenges such as inadequate response rates and high placebo effects highlight the need for improved therapies and a deeper understanding of treatment expectations. Patient expectations play a crucial role in treatment outcomes but have not been systematically investigated in the c...
Introduction The aesthetic qualities of psychedelic experiences have long been documented, but their specific contribution to therapeutic outcomes remains understudied. Aesthetic experiences may facilitate emotional breakthroughs and cognitive shifts, potentially playing a crucial role in the lasting psychological benefits observed following psychedelic use....
This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing. In this study, the...
This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Sc...
OBJECTIVE: Psychedelic therapies are promising new treatment options in psychiatry. Including the use of physical touch as part of treatment is an area of debate. This study aimed to characterize the viewpoints of practitioners on the use of touch in psychedelic therapy. METHODS: An anonymous survey was distributed via e-mail to the contacts listed on Clinic...
Most Delphi studies primarily rely on questionnaires and subsequent quantitative ratings across multiple rounds to learn about a complex issue. This article demonstrates the integration of qualitative inquiry into a Delphi study to enhance and complement quantitative findings. We conducted a mixed methods Delphi study to establish a comprehensive list of qua...
Psychotherapy in combination with pharmacological treatments is often used to treat affective symptoms in patients with cancer. However, the effectiveness of the most commonly used medications is limited by the risk of adverse effects. Two placebo-controlled trials have found that patients with cancer-related psychiatric distress experienced rapid and susta...
Introduction: Considering the increasing evidence supporting psilocybin's efficacy in therapeutic settings, it is essential to deepen our understanding of its subjective meanings and effects to enhance its integration into psychotherapy. Current knowledge is primarily based on psychometric assessments or unstructured personal reports, leaving a gap in the qu...
Psychedelics have shown significant therapeutic benefit for those struggling with their mental health (Luoma et al., 2020). Previous research has suggested that mental health practitioners hold favorable attitudes towards psychedelic-assisted therapy (PAT) but lack the proper knowledge to counsel clients on the subject (Kucsera et al., 2023). As PAT becomes ...
Objective: Prior research has found an association between psychedelic use and reduced stigma attached to mental illness. However, whether psychedelics alleviate stigma-related distress remains unclear. Since stigma impacts different groups uniquely, any moderating effect of psychedelics on stigma-related distress is likely to vary across subpopulations. Thi...
OBJECTIVE: Psychedelics are able to trigger highly intense and profound alterations in self-consciousness, perception, affective, and cognitive processes. Indeed, recent studies show that ketamine and psilocybin could be used as fast-acting antidepressants. However, the molecular and neurochemical mechanisms of these psychedelics and their actions at the lev...
N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to sub...
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...
The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. A DMT infusion mimicking oral LSD and psilocybin administrations will be tested, as well as intravenously administered ketanserin. Lysergi...
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 ...
The few reports on effects of psychedelic substances on cerebral metabolic rate (CMRglc) indicate increases (psilocybin; human FDG-PET) or decreases (LSD, rat autoradiography; 5-MeO-DMT rat autoradiography). There are no reports of effects of DMT and/or harmine on cerebral energy metabolism. The primary objective of this study is thus to assess acute cerebro...
This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic. Aim 1: To assess short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on sympt...
In recent years, there has been a significant surge of interest in psychedelic research. These studies encompass both neuroscience and their potential clinical applications. This phenomenon, often referred to as the "Psychedelic Renaissance", includes studies on compounds such as psilocybin, MDMA, DMT, and LSD used for the treatment of depression, post-traum...
