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...
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 ...
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...
Importance: Psilocybin shows promise in treating depression, although limitations of previous research warrant further research. Objective: To investigate the efficacy and safety of oral psilocybin, 25 mg, with adjunct psychotherapy in treatment-resistant depression (TRD). Design, Setting, and Participants: This was a 2-center, triple-blinded (investigator, ...
BACKGROUND: Current treatments for obsessive-compulsive disorder (OCD), including serotonin reuptake inhibitors and cognitive-behavioral therapy, are often insufficient. Psilocybin, a 5HT2a agonist psychedelic, has shown promise for treating OCD, but rigorous evidence is still needed. AIMS: This randomized clinical trial evaluated safety, tolerability, and b...
Importance: Annual tobacco-related death estimates are 480 000 in the US and 8 million worldwide, surpassing mortality for other abused substances. Most smoking cessation interventions result in modest long-term success. Objective: To compare prolonged smoking abstinence rates in smokers receiving psilocybin plus cognitive behavioral therapy (CBT) with those...
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 study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session...
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustm...
Background: Major depressive disorder (MDD) is a highly prevalent and disabling psychiatric condition associated with substantial clinical, social, and economic burden [1,2]. Despite the availability of conventional antidepressants, their limited effectiveness, delayed onset of action, and high relapse rates have renewed interest in innovative therapeutic ap...
Abstract Lyme disease, caused by the bacterium Borrelia burgdorferi, is the most common vector-borne disease in the United States and Europe. Although antibiotics effectively treat most cases, an estimated 10-20% of patients develop post-treatment Lyme disease (PTLD), a chronic syndrome marked by fatigue, pain, cognitive difficulties, mood disturbance, and r...
BackgroundPsychedelics such as lysergic acid diethylamide (LSD) and psilocybin have shown a beneficial effect on substance use disorder (SUD) symptoms. In this systematic review, we aimed to assess the efficacy and safety of psychoactive tryptamines in patients with an SUD or non-substance-related disorder (i.e., gambling disorder) in order to provide a comp...
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with bupr...
Abstract IMPORTANCE Microdosing psilocybin may be a novel treatment for major depressive disorder (MDD). OBJECTIVE Assessing the antidepressant effects and safety of repeated low doses of psilocybin in participants diagnosed with MDD. DESIGN This was a Phase II, randomized, double-blind, placebo-controlled clinical trial. SETTING The trial was conducted from...
BACKGROUND: Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental hea...
Abstract Background and aims Despite growing popularity and increasing legal access, psychedelic therapy remains financially inaccessible to many. This study was designed to test the feasibility of conducting group psilocybin therapy in low-income adults with depression in Oregon's regulated psilocybin program. Methods An open label, uncontrolled design was ...
