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...
Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental condition in which prenatal stress and long-lasting disruptions of excitatory-inhibitory (E/I) balance have been implicated as key vulnerability factors. Although established pharmacological and behavioral treatments are effective for many individuals, they are not universally ...
Background: Understanding the benefits of psychedelic-assisted therapy (PAT) will require scientific attention to the causal interaction between the therapeutic context and process. Measuring what actually happens during PAT in large-scale studies will be an essential component of this work. Objective: We aim to develop and preliminarily evaluate the feasibi...
BACKGROUND: We know little about the extent psychedelic substances are consumed therapeutically and/or discussed with medical professionals despite renewed global interest in these substances. METHODS: We examined self-reported responses from the 2023 International Cannabis Policy Study (ICPS) in repeated cross-sectional surveys in Canada, the United States,...
Chronic pain is common, costly, and for many, remains inadequately treated by existing pharmacologic and non-pharmacologic approaches. In parallel with growing dissatisfaction with conventional therapies, classic serotonergic psychedelics, such as psilocybin, lysergic acid diethylamide (LSD), ayahuasca, N,N-dimethyltryptamine (DMT), and mescaline, administer...
Background/Objectives: Psilocybin-assisted therapy (PAT) is a promising intervention to alleviate existential distress among patients with advanced cancer receiving palliative care. However, evidence on how to integrate PAT into routine oncology and palliative care services remains scarce. This study aimed to examine real-world PAT implementation, identify f...
Abstract Background Prolonged grief disorder (PGD) is a clinically distinguishable bereavement-related condition characterized by persistent yearning, identity disruption, and impaired functioning, formalized in DSM-5-TR and ICD-11 (6L72) and empirically distinguishable from but frequently co-occurring with major depressive disorder. Approximately 7 to 10 pe...
Psilocybin, the main psychoactive compound in Psilocybe cubensis mushrooms, has gained considerable attention for its therapeutic potential. Current research focuses only on isolated psilocybin, neglecting the broader pharmacological and cultural use of the whole mushroom. This perspective advocates for an integrative approach that includes standardised P. c...
Aims: Recently the therapies that utilize psychedelics have emerged as promising treatments for mood disorders, trauma-related disorders, and substance use disorders. While there is a growing body of research comparing various interventions directly, the majority of available research has been conducted in an indirect manner; therefore, Network Meta-Analysis...
PURPOSE: Expectations strongly shape participant experiences in clinical trials, contributing to placebo effects that complicate interpretation of outcomes. While quantitative tools exist to measure expectations, their subjective and multidimensional nature, especially for individuals with treatment-resistant depression (TRD), remains underexplored. This stu...
PURPOSE: Psychedelics have received considerable attention due to their potential in treating psychiatric disorders. The "setting" during psychedelic-assisted therapy (PAT) is recognized as playing a central role in the experience, during which music features prominently. Although music is theorized as directing and shaping psychedelic sessions, its precise ...
Background: The impact of classic psychedelics (5-HT2A receptor agonists) on personality traits has been studied for decades, and it has been hypothesized that the mechanisms underlying these changes are linked to agonism at cortical serotonergic 5-HT2A receptors. However, research results are contradictory. Therefore, the present paper aims to systematicall...
This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incur...
Abstract Background and Aims Psilocybin-assisted psychotherapy (PAP) is a novel, transdiagnostic treatment in which the 5-HT2A receptor agonist psilocybin is combined with psychotherapy. Studies to date have evaluated PAP's effects on depression, substance use, and end-of-life adjustment. Relatively less attention has been given to its effects on anxiety sym...
Introduction: Despite renewed investigations into classical psychedelic compounds, their pharmacokinetic profiles remain incompletely understood. Methods: This systematic review collated data from healthy adult volunteers on the pharmacokinetic properties of lysergic acid diethylamide (LSD), psilocybin, dimethyltryptamine (DMT), mescaline, and 5-methoxy- N,N...
Serotonergic psychedelics are increasingly investigated as treatments for affective disorders. Concerns persist regarding their potential to induce hypomania or mania, particularly in individuals with bipolar spectrum vulnerability. Whether these substances precipitate transient mood switches or contribute to persistent bipolar illness or diagnostic transiti...
Maintaining effective blinding is a major methodological challenge in psychedelic research. This study provides a comprehensive evaluation of blinding integrity in 120 healthy volunteers who received either psilocybin, MDMA, or methylphenidate (active placebo) in a double-blind, randomized controlled trial. Using a multi-level assessment incorporating forced...
