BACKGROUND: To investigate the association between pre-trial expectancy, suggestibility, and response to treatment in a trial of escitalopram and investigational drug, COMP360, psilocybin, in the treatment of major depressive disorder (ClinicalTrials.gov registration: NCT03429075). METHODS: = 55) from our recent double-blind, parallel-group, randomized head-...
Introduction to the Special Section on Psychedelics Research and Treatment Dominic Sisti Against a backdrop of post-pandemic malaise, diseases of despair, and a fragmented mental health care system, psychedelics have enjoyed a resurgence of interest as powerful psychotherapeutic agents and as catalysts of personal growth. The true power of these substances-s...
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...
Psychedelic-assisted treatment (PAT) for mental health is in renaissance. Psilocybin and MDMA stand near FDA approval, and US cities and states are decriminalizing or regulating the non-clinical use of psilocybin. However, neither FDA indications nor a regulated use model sufficiently address the complex needs and opportunities for an improved treatment of a...
Background: Psilocybin, a classic hallucinogen, may eventually be approved by the United States Food and Drug Administration for treatment-resistant depression. However, we are aware of only one published national survey of American psychiatrists regarding their opinions about hallucinogens and hallucinogen-assisted therapy, conducted by our group in 2016. H...
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...
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...
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...
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...
A multidisciplinary pharmacognostic, forensic and pharmaceutical, organizational and legal, clinical and pharmacological, forensic and medical, toxicological, chemical evaluation of the irrational use of spices in smoking mixtures from the group of entheogens was carried out. An expert assessment of spices - plants and mushrooms containing psychoactive subst...
The COVID-19 pandemic has resulted in a surge in depression cases, a pervasive and debilitating mental illness1. This trend is evident in the increased prescriptions for antidepressants. Depression is a chronic condition that affects a significant proportion of the global population, with ~280 million people, or about 3.8%, suffering from it. As a result, it...
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...
Abstract Background Psilocybin Therapy (PT) is being increasingly studied as a psychiatric intervention. Personality relates to mental health and can be used to probe the nature of PT's therapeutic action. Methods In a phase 2, double-blind, randomized, active comparator controlled trial involving patients with moderate-to-severe major depressive disorder, w...
Several studies have been conducted and more are underway examining psilocybin-assisted therapy as a treatment for various psychiatric conditions including depressive disorders, anxiety disorders, and alcohol use disorder. However, many studies have been limited by small sample size and have not comprehensively evaluated treatment risks outside of controlled...
Background: Recent years have seen a resurgence in clinical interest in, and increased public acceptance of, psychedelic drugs in Canada. However, our understanding of how psychedelic drugs are currently used in Canada remains limited. We developed the Canadian Psychedelic Survey (CPS) to gather real-world evidence about psychedelic drug use in Canada. This ...
Introduction: Psilocybin has shown long-lasting antidepressant effects in preclinical and clinical trials, but the mechanisms responsible are unclear. As both passive coping strategies and pattern separation deficits are characteristics of major depression, we used adult female rats subjected to adolescent chronic restraint stress (aCRS) to investigate the e...
Background: An emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves. Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects ...
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, ...