ABSTRACT Clinical trials suggest that a single dose of psilocybin is an effective treatment for substance use disorders (SUDs). Choice impulsivity is a value-based decision-making bias that predicts drug-intake escalation and is commonly associated with SUDs. The dorsomedial prefrontal cortex (dmPFC) regulates choice impulsivity and is enriched with 5-HT2A r...
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (B...
Background Psychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This study’s primary objectives examined the feasibility and safety of administering movement tasks following low-t...
With the resurgence of psychedelic research and the growing interest in their therapeutic potential, there is an urgent need to understand how these compounds act across biological sexes. Despite widespread interest in their use for conditions marked by social impairments, including depression, anxiety, and anorexia nervosa, the influence of sex as a biologi...
Psilocybin is a classic psychedelic drug known to alter subjective experience and elicit long-term psychological changes, enhancing cognitive flexibility and reducing rigid self-related beliefs. Combined with compassion motivational primes that involve generating mental representations of compassion, it may increase the potential for activating the care-affi...
Classic psychedelics such as lysergic acid diethylamide (LSD) and psilocybin induce mild cardiovascular activation in addition to their psychological effects. While these effects are well described in healthy adults, little is known about their dynamics in clinical populations undergoing psychedelic-assisted psychotherapy. This retrospective, observational, ...
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 255 partici...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating mental disorder commonly treated with selective serotonin reuptake inhibitors, atypical antipsychotic augmentation and cognitive-behavioural therapy. However, up to 60% of people with OCD do not respond to these treatments. Therefore, a novel intervention, psilocybin-assisted psychotherapy (PA...
Introduced in 2014 and revised in 2018, the entropic brain hypothesis has accrued a wealth of supportive evidence. The hypothesis states that- along a dimension of breadth of conscious experience- ‘expansive states’ reliably exhibit increased brain entropy whereas the inverse applies for states of no or reduced consciousness. Examples of expansive states inc...
Introduced in 2014 and revised in 2018, the entropic brain hypothesis has accrued a wealth of supportive evidence. The hypothesis states that- along a dimension of breadth of conscious experience- ‘expansive states’ reliably exhibit increased brain entropy whereas the inverse applies for states of no or reduced consciousness. Examples of expansive states inc...
Introduction: The subjective effects of psilocybin on obsessive-compulsive disorder (OCD) are under-explored. Therefore, we conducted a qualitative study of participant experiences from the first randomized placebo-controlled trial of single-dose psilocybin combined with unstructured and non-directive support for individuals with treatment-refractory OCD. Ou...
PURPOSE/BACKGROUND: The therapeutic effects of psilocybin treatment are thought to be influenced by the subjective dose-dependent psychedelic experience, as well as the individual participant's mindset and the treatment environment. However, the relative contribution of an individual's pretreatment clinical characteristics and their subjective psychedelic ex...
Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs ...
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with...
This narrative review synthesized the use of psilocybin-assisted therapy as a promising treatment for alleviating death anxiety in terminally ill patients. The insights presented are derived from findings reported in previous studies. Therefore, this review aimed to assess the efficacy, pharmacology, and mechanisms by which psilocybin alters brain function b...
Background Classic serotonergic psychedelics such as LSD and psilocybin show promising antidepressant effects in controlled trials, but real-world data from routine clinical care remain limited. Methods This study retrospectively analysed routine data from adults with treatment-resistant depressive and/or anxiety disorders who received a first standardized P...
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2...
This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will fo...
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participant...
