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...
Background: Social anxiety disorder is a chronic and disabling condition with limited response to standard therapies. Low-dose psilocybin may enhance the effectiveness of exposure-based treatments by modulating neural circuits associated with fear and avoidance. Virtual reality exposure therapy offers a controlled and individualized platform for intervention...
PURPOSE OF REVIEW: There is growing evidence that psychedelics and associated treatment modalities may offer therapeutic benefits across a range of psychiatric conditions. Anorexia nervosa (AN), a serious and often treatment-resistant illness associated with significant morbidity and mortality, is one such condition for which psilocybin-assisted therapy (PAT...
Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. The current study sought expert recommendations on informed consent challenges, best practices and recommendations for supervised psilocybin experiences across various settings. Participants with psilocybin content...
Importance: The Oregon Psilocybin Services (OPS) program is the first statewide, regulated framework for legal psilocybin in the U.S. Analyzing inaugural-year utilization and safety is essential for informing policy and equity monitoring. Methods: We conducted a descriptive analysis of statewide aggregate data from the OPS Public Dashboard (January 1-Decembe...
The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be ...
The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral support for methamphetamine use disorder (MUD). Participants have a diagnosis of methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks. The objective of ...
The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.
Introduction and Objective.Treatment-resistant depression (TRD) remains a major clinical challenge affecting patients who fail to respond to at least two adequate antidepressant trials.The development of rapid-acting interventions targeting non-monoaminergic pathways has introduced new therapeutic possibilities.The aim of the review is to critically examine ...
To evaluate the efficacy, safety, and durability of a single 25-mg dose of a proprietary, synthetic formulation of psilocybin with psychological support for reducing chronic suicidal ideation in a treatment-resistant population. ), and ≥2 prior antidepressant treatment failures received a single 25-mg dose of psilocybin administered within a structured prepa...
The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will...
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...
Introduction and purpose: Depressive disorders, particularly major depressive disorder (MDD) and treatment-resistant depression (TRD), remain major causes of disability worldwide. Conventional treatments are limited by delayed onset, incomplete response, relapse, and adverse effects. This review summarizes current evidence on the efficacy, safety, and durabi...
Importance: Cocaine use disorder is a serious public health problem and no medications have been proven effective for its treatment. Objective: To evaluate psilocybin in the treatment of cocaine use disorder. It was hypothesized that psilocybin, compared with placebo, would yield a higher percentage of cocaine abstinent days, a greater likelihood of complete...
Non-human models, including fish, are increasingly important for investigating how pharmacological agents such as hallucinogens influence behavior, physiology, and cellular processes. These models help to reveal underlying mechanisms and to support assessments of toxicological impact, efficacy, and safety. In this study, we used isogenic lineages of the amph...
This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and su...
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of sc...
