The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in...
Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-...
Based on its in vitro profile and preliminary evidence, 4-bromo-2,5-dimethoxyphenethylamine (2C-B) may have psychoactive properties that are similar to 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin, which are investigated for the treatment of posttraumatic stress disorder and depressive disorders. We compared acute effects of 2C-B (10, 20, and 30 m...
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, sub...
BACKGROUND AND OBJECTIVE: Dextromethorphan (DXM), widely used as an over-the-counter antitussive in the United States, exhibits psychoactive effects at supratherapeutic levels that overlap with those of classic and dissociative psychedelics. Reported psychoactive effects have generated interest in DXM as a potential therapeutic agent for treatment-resistant ...
This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin session...
The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder. Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic str...
Background and objective: Anxiety disorders are among the most prevalent psychiatric disorders worldwide and affect all age groups. Current pharmacological treatments, such as selective serotonergic reuptake inhibitors (SSRI’s) and benzodiazepines, have limitations in terms of adverse effects and efficacy, which highlights the need for alternative therapies....
ABSTRACT Treatment-resistant depression (TRD) is characterized by chronic symptoms, impaired functioning, and limited response to conventional antidepressant therapy. Contemporary reviews have highlighted increasing interest in psilocybin-assisted therapy as a mechanistically novel approach for depressive disorders, grounded in early feasibility work demonst...
This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD...
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological m...
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...
Importance: Psilocybin has been proposed as a rapid-acting antidepressant (onset 6 weeks), but evidence from randomized clinical trials remains limited, particularly in the broader major depressive disorder (MDD) population. Objective: To assess short-term and long-term antidepressant effects of psilocybin therapy in patients with MDD. Design, Setting, and P...
Abstract Background: Conventional pharmacotherapy for treatment-resistant depression (TRD) has been found to provide limited benefit in a subset of patients. Psilocybin-assisted therapy has emerged as a promising modality due to its rapid-acting antidepressant effects and favourable tolerability profile shown in early trials. Despite growing research interes...
Interest in psychedelic-assisted therapy (PAT) is surging across research and medical communities, prompting the discussion of policy shifts that reflect growing openness to implementing psychedelics in clinical practice. State-level psychedelic reform in the United States has accelerated since 2019, with legalization projected to reach most states within th...
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...
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...
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinic...
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with S...
