Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to e...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, f...
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM1: To compare the e...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risper...
Abstract Background: This case describes a substance-induced manic episode with psychotic features in which interaction with an AI (artificial intelligence) chatbot appeared to corroborate and reinforce the patient’s delusional thought content and to contradict medical advice. Excerpts from the patient’s interactions with the AI chatbot provide novel clinica...
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people ...
This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be m...
There has been a renewed interest in the use of various psychedelic agents as potential therapies for multiple psychiatric conditions, including post-traumatic stress disorder (PTSD), major depressive disorder (MDD), generalized anxiety disorder (GAD), to name a few. This follows the recent accumulation of evidence for ketamine pharmacotherapy and a rapid pr...
A key distinction among clinical trials on psilocybin treatments, for example, those targeting depression, has been whether the psilocybin dosing session is combined with bona fide psychotherapy or with what is referred to as “psychological support” (1-3). The most developed model of psychological support is the Compass Psychological Support Model (CPSM; 1)....
Binge Eating Disorder (BED) is the most prevalent eating disorder and is associated with psychiatric comorbidities, health impairments, and decreased quality of life. Emerging evidence suggests that psilocybin-assisted therapy may promote cognitive and emotional flexibility and disrupt maladaptive behavioral patterns, making it a promising candidate for BED ...
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC). This trail will test the following 2 aims: AIM1: To test the safety and feasibility of an active psilocybi...
IntroductionSerotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to addres...
Abstract Background: Body Image Disturbance (BID) is the distorted experience of one’s body. BID presents a risk for the onset, maintenance and relapse of body dysmorphic disorder and eating disorders, including anorexia nervosa (AN). Current treatments tend to focus on the cognitive and behavioural aspects while overlooking the perceptual symptoms and BID f...
SUMMARY: Although the development of psilocybin therapy has come as a surprise to many, modern research with the drug has been ongoing for 25 years. Psilocybin therapy is composed of psilocybin dosing sessions embedded within a wider process of psychoeducation, psychological support and integration. Early phase clinical trial evidence is promising, particula...
The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This...
