Cost-effectiveness of psilocybin-assisted therapy for severe depression: exploratory findings from a decision analytic model
BACKGROUND: There is growing evidence to support the use of the psychedelic drug psilocybin for difficult-to-treat depression. This paper compares the cost-effectiveness of psilocybin-assisted psychotherapy (PAP) with conventional medication, cognitive behavioural therapy (CBT), and the combination of conventional medication and CBT. METHODS: A decision mode...
Development and psychometric validation of a novel scale for measuring ‘psychedelic preparedness’
Preparing participants for psychedelic experiences is crucial for ensuring these experiences are safe, and potentially, beneficial. However, there is currently no validated measure to assess the extent to which participants are well-prepared for such experiences. Our study aimed to address this gap by developing, validating, and testing the Psychedelic Prepa...
Development and psychometric validation of a novel scale for measuring ‘psychedelic preparedness’
Preparing participants for psychedelic experiences is crucial for ensuring these experiences are safe, and potentially, beneficial. However, there is currently no validated measure to assess the extent to which participants are well-prepared for such experiences. Our study aimed to address this gap by developing, validating, and testing the Psychedelic Prepa...
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial
Background: Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature. Methods: In an exploratory placebo-controlled, within-subject, fi...
Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life
BACKGROUND: COMP360 is a proprietary, synthetic formulation of psilocybin being developed for treatment-resistant depression (TRD), a burdensome, life-threatening illness with high global impact. Here, we expand upon the previous report of primary outcomes from a phase 2 study of COMP360 in individuals with TRD-the largest randomised controlled clinical tria...
Psychedelic Microdosing, Mindfulness, and Anxiety: A Cross-Sectional Mediation Study.
While anecdotal reports claim that psychedelic microdosing reduces anxiety and mood symptoms, evidence supporting these claims is scarce. This cross-sectional study investigated the association between microdosing and trait anxiety. Furthermore, it was investigated if trait mindfulness mediated this association. Participants completed anonymous online questi...
Exploratory investigation of a patient-informed low-dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double-blind, placebo-controlled trial.
ObjectiveUsing a patient-informed regimen, we conducted an exploratory randomized, double-blind, placebo-controlled study to systematically investigate the effects of psilocybin in cluster headache.BackgroundSustained reductions in cluster headache burden after limited quantities of psilocybin-containing mushrooms are anecdotally reported, although to date t...
Effects of psilocybin versus escitalopram on rumination and thought suppression in depression.
BackgroundMajor depressive disorder is often associated with maladaptive coping strategies, including rumination and thought suppression.AimsTo assess the comparative effect of the selective serotonin reuptake inhibitor escitalopram, and the serotonergic psychedelic psilocybin (COMP360), on rumination and thought suppression in major depressive disorder.Meth...
The Watts Connectedness Scale: a new scale for measuring a sense of connectedness to self, others, and world.
RationaleA general feeling of disconnection has been associated with mental and emotional suffering. Improvements to a sense of connectedness to self, others and the wider world have been reported by participants in clinical trials of psychedelic therapy. Such accounts have led us to a definition of the psychological construct of 'connectedness' as 'a state ...
Analytical profile, in vitro metabolism and behavioral properties of the lysergamide 1P-AL-LAD.
Lysergic acid diethylamide (LSD) is known to induce powerful psychoactive effects in humans, which cemented its status as an important tool for clinical research. A range of analogues and derivatives has been investigated over the years, including those classified as new psychoactive substances. This study presents the characterization of the novel lysergami...
Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression.
Background: Across psychotherapeutic frameworks, the strength of the therapeutic alliance has been found to correlate with treatment outcomes; however, its role has never been formally assessed in a trial of psychedelic-assisted therapy. We aimed to investigate the relationships between therapeutic alliance and rapport, the quality of the acute psychedelic e...
Tentative identification of in vitro metabolites of O-acetylpsilocin (psilacetin, 4-AcO-DMT) by UHPLC-Q-Orbitrap MS.
4-Acetoxy-N,N-dimethyltryptamine (4-AcO-DMT, psilacetin, O-acetylpsilocin) is a synthetic tryptamine with psychedelic properties. Psilacetin may also act as precursor drug of psilocin, similar to psilocybin, but little is known about its metabolism. In this study, the phase I and phase II in vitro metabolism of 4-AcO-DMT was investigated with pooled human li...
Phenomenological assessment of psychedelics induced experiences: Translation and validation of the German Challenging Experience Questionnaire (CEQ) and Ego-Dissolution Inventory (EDI).
Several measures have been designed to assess subjective experiences induced by psychedelic substances or other mind-altering drugs as well as non-pharmacological methods. Recently, two self-report questionnaires have been introduced to measure acute adverse effects following psilocybin ingestion and the phenomenon of ego-dissolution associated with the use ...
The Psychedelic Integration Scales: Tools for Measuring Psychedelic Integration Behaviors and Experiences.
In this study, we describe the development and initial validation of two psychometric scales for measuring psychedelic integration. Psychedelic integration refers to the post-acute period of time following psychedelic drug administration. We created the Integration Engagement Scale (IES) to capture positive behavioral engagement with integration and the Expe...
Psychedelics and Mindfulness: A Systematic Review and Meta-Analysis
Background and Aims: The benefits of classic serotonergic psychedelics (e.g. psilocybin, LSD, DMT, ayahuasca) are becoming more widely known with the resurgence in research in the past decade. Furthermore, the benefits of mindfulness are well documented. However, no systematic reviews have examined linkage of mindfulness and psychedelics use. The aim of this...
Psychedelics and Mindfulness: A Systematic Review and Meta-Analysis
Background and Aims: The benefits of classic serotonergic psychedelics (e.g. psilocybin, LSD, DMT, ayahuasca) are becoming more widely known with the resurgence in research in the past decade. Furthermore, the benefits of mindfulness are well documented. However, no systematic reviews have examined linkage of mindfulness and psychedelics use. The aim of this...
Neuropsychological Functioning in Users of Serotonergic Psychedelics - A Systematic Review and Meta-Analysis.
Background: Serotonergic psychedelics (SPs) like LSD, psilocybin, DMT, and mescaline are a heterogeneous group of substances that share agonism at 5-HT2a receptors. Besides the ability of these substances to facilitate profoundly altered states of consciousness, persisting psychological effects have been reported after single administrations, which outlast t...
Phenomenological assessment of psychedelic induced experiences: Translation and validation of the German Challenging Experience Questionnaire (CEQ) and Ego-Dissolution Inventory (EDI)
Several measures have been designed to assess subjective experiences induced by psychedelic substances and other mind-altering drugs or non-pharmacological methods. Recently, two self-report questionnaires have been introduced to measure acute adverse effects following psilocybin ingestion and the phenomenon of ego-dissolution associated with psychedelic use...
Phenomenological assessment of psychedelic induced experiences: Translation and validation of the German Challenging Experience Questionnaire (CEQ) and Ego-Dissolution Inventory (EDI)
Several measures have been designed to assess subjective experiences induced by psychedelic substances and other mind-altering drugs or non-pharmacological methods. Recently, two self-report questionnaires have been introduced to measure acute adverse effects following psilocybin ingestion and the phenomenon of ego-dissolution associated with psychedelic use...