There is growing interest in psychedelic compounds such as psilocybin, 3,4-metheylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT) given emerging research on potential uses as treatments for a variety of health conditions. The United States Food and Drug Administration (FDA) has granted multiple “Breakthrough The...
Classical serotonergic psychedelics, such as psilocybin, show emerging evidence of therapeutic potential across a range of mental health disorders, including depression, anxiety, and substance use disorders, with indications of transdiagnostic efficacy. While early-phase studies yielded encouraging results, recent larger-scale phase 3 trials, such as those e...
In late spring 2024, CDC was alerted to an outbreak of poisoning potentially associated with eating Diamond Shruumz microdosing chocolate bars. Diamond Shruumz microdosing chocolate bars are edible products designed so that small doses of mushroom-derived psychoactive compounds and other psychoactive ingredients can be eaten in a presectioned serving. In res...
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 ...
The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care. -The name of the study drug involved in this study is Psilocybin The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice car...
Serotonergic psychedelics, such as lysergic acid diethylamide, and psilocybin, and the entactogen 3,4-methylenedioxymethamphetamine exhibit agonist activity at the 5-hydroxytryptamine 2B receptor, a signalling pathway known to mechanistically mediate drug-induced valvular heart disease. This systematic review evaluates whether chronic or repeated use of psyc...
BACKGROUND: Psychedelics such as 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin are showing promising results in clinical trials for the treatment of mental health disorders, including post-traumatic stress disorder, addiction, and treatment-resistant depression. US Food and Drug Administration approval may be on the horizon. Yet, little is known ab...
Background: Psilocybin therapy is an emerging treatment for cancer-related anxiety, depression, and existential distress. Most clinical trials to date have studied individual models of psilocybin therapy, but group models may offer increased access and benefits of community. Purpose: This technical report describes a group facilitation model developed for an...
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative) This study is a phase 2 open label, single center, concur...
In 1970, Congress passed the Controlled Substances Act and swiftly placed psilocybin (the active chemical in “magic mushrooms”) under Schedule I-the strictest level of regulation withheld for substances with “no currently accepted medical use.” While the United States has maintained this rigid framework, Jamaica has taken the opposite approach. Psilocybin wa...
Psychedelic research is progressing at breakneck speed and is creating new challenges for drug developers, regulatory authorities, and legislators. Most “classic” psychedelics undergoing clinical investigation are C-I controlled drugs with perceived high potential for abuse and no medical use. These and next-generation psychedelic drug-candidates require sci...
The study hypothesis is that the antidepressant effect of psilocybin is mediated by a normalization of the functioning of the positive valence system. Depressive states, especially moderate to severe depressions that associate a certain level of anhedonia, produce an overvaluation of the cost of efforts and an infra-evaluation of the possible rewards derived...
With MDMA, LSD, and psilocybin receiving “Breakthrough Therapy” designation by the U.S. Food and Drug Administration (FDA) and moving into Phase 3 clinical trials, we are closer than ever to legal administration of these compounds for mental health treatment. Research from Lykos, Usona Institute, Mindmed, Compass Pathways, and Johns Hopkins, among others, ha...
BACKGROUND: People with HIV (PWH) are disproportionately affected by cigarette use, with a 40 - 70% prevalence rate. Although many express a strong interest in quitting, many PWH who smoke experience lower cessation rates with traditional treatments, in part due to their comorbid anxiety and depressive symptoms. Psilocybin, a classic psychedelic referred to ...
ImportancePsilocybin has demonstrated rapid and sustained antidepressant efficacy, with acute-phase effect sizes often more than double those for conventional antidepressants. However, concerns have been raised that high rates of functional unblinding in combination with trial participants with positive expectations of psychedelic use might bias treatment ou...
The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variabi...
Opioid-related overdose deaths have reached record high levels, and novel treatments for opioid use disorder (OUD) are needed. The three United States Food and Drug Administration (FDA)-approved medications for OUD function primarily at the mu-opioid receptor. While these remain the gold-standard treatment for OUD, they have shortcomings and treatment option...
Psilocybin is an active alkaloid found in magic mushrooms (Psilocybe cubensis). It is classified as a Class I Psychoactive Substance due to its psychoactive properties. Recent research has suggested that psilocybin holds potential for treating major depressive disorder. The objective of this study was to develop a physiologically based pharmacokinetic (PBPK)...
The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to ...
