BACKGROUND AND AIMS: Australia recently down-scheduled and authorised psychedelic-assisted therapies, including psilocybin, for certain mental health conditions. Evidence is emerging for potential application in substance use disorder treatment. However, regulatory developments have outpaced implementation readiness. While service leaders and clinicians are ...
Background: Self-stigma refers to the internalization of negative societal beliefs and has been associated with reduced self-efficacy, self-esteem and treatment avoidance among substance users. However, little research has explored antecedents of self-stigma such as substance use motives. This may be particularly salient for psilocybin which is used both as ...
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ag...
Psilocybin is studied as innovative medication in anxiety, substance abuse and treatment-resistant depression. Animal studies show that psychedelics promote neuronal plasticity by strengthening synaptic responses and protein synthesis. However, the exact molecular and cellular changes induced by psilocybin in the human brain are not known. Here, we treated h...
Background: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). However, the effects of open-label administration following blinded treatment are unclear. Here, we present safety and efficacy data from an open-label extension of a Phase II RCT (NCT02061293) examining PAT for AUD. Methods:...
Background/Objectives: Psilocybin has re-emerged as a promising intervention for neuropsychiatric disorders including major depressive disorder, treatment-resistant depression, anxiety associated with life-threatening illness, obsessive compulsive disorder, and substance use disorders. However, conventional randomized controlled trials (RCTs)-the current gol...
Note: The trial is only eligible for citizens of Denmark. The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD). To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a ...
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1. Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all partici...
Psilocybin, chemically known as (4-phosphoryloxy-N, N-dimethyltryptamine, 4-PODMT), is derived from the psychoactive mushroom genus, Psilocybe. Of the four active metabolites, psilocin readily enters systemic circulation. The psychoactive effects of psilocin are thought to arise through partial agonist effects at the 5-HT2A receptor. Psychedelic drugs, inclu...
INTRODUCTION: After decades of regulatory marginalization, psychedelic compounds have reemerged as promising therapeutic tools in psychiatry, driven by unmet clinical needs in treatment-resistant mental disorders and by growing evidence of rapid and sustained effects on mood, cognition, and behavior. AREAS COVERED: This narrative review critically examined t...
Disorders of consciousness pose major therapeutic challenges owing to the complexity of underlying brain dysfunctions. Current pharmacological interventions explored in disorders of consciousness target distinct molecular systems, including dopaminergic modulators (amantadine, levodopa, apomorphine, bromocriptine, selegiline, methylphenidate, and modafinil),...
While the limitations of existing treatment options have spurred investigations into the applicability of psychedelic therapies for chronic and treatment-resistant psychological disorders, there remain significant unresolved issues pertaining to how these treatments should be regulated and the implementation of an ethical framework for their widespread deliv...
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulat...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
Psilocybin, N,N-dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are psychedelic compounds with therapeutic potential for depression, anxiety, and post-traumatic stress. However, their relevance to endurance athletes, who face particular psychological and physical stressors, remains underexplored. This ...
RATIONALE: The nature and role of the psychological support provided in psychedelic-assisted treatments for psychiatric disorders are currently the object of debate. How this support is conceptualized-as a vector for therapeutic change or framework for risk minimization-has far-reaching consequences in terms of how these treatments should be regulated, deliv...
Depression and psychological distress are highly prevalent among patients with cancer and are associated with impaired quality of life, reduced treatment adherence, and poorer clinical outcomes. Standard pharmacological and psychosocial interventions often demonstrate limited efficacy or delayed onset of action in oncological and palliative settings. Psilocy...
Psilocybin-assisted therapies are innovative therapeutic approaches, particularly in the treatment of depression. However, there are sparse studies providing functional magnetic resonance imaging (fMRI) evidence elucidating the underlying biological mechanisms that support clinical outcomes. This review aims to comprehensively gather all the evidence reporte...
