This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat ...
Abstract Rationale: Major depressive disorder (MDD) shows marked sex differences in prevalence, symptomatology, and treatment response. However, women remain underrepresented in many clinical trials, and sex-specific treatment outcomes are rarely examined. Objectives This study reanalyzed data from a randomized controlled trial comparing psilocybin and escit...
Serotonergic psychedelics are increasingly investigated as treatments for affective disorders. Concerns persist regarding their potential to induce hypomania or mania, particularly in individuals with bipolar spectrum vulnerability. Whether these substances precipitate transient mood switches or contribute to persistent bipolar illness or diagnostic transiti...
This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings o...
AbstractIntroduction Psilocybin, a naturally occurring psychedelic compound found in certain mushroom species, has gained substantial clinical, scientific, and cultural attention in recent years. Despite this growing interest and evolving policy landscape, nationally representative estimates of recent psilocybin use in the United States remain limited. Under...
Reliable documentation of the traditional use of serotonergic psychedelics has long been confined to the Americas. Prevailing narratives often overstate the global prevalence and uniformity of traditional psychedelic use, extrapolating from a limited set of well-documented cases. Here, we report evidence of psilocybin mushroom use among Basotho traditional h...
One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin wil...
PurposeTo examine the prevalence of lifetime ("ever") cannabis and classic psychedelic use, and their co-use among U.S. adults aged ≥ 50 years with versus without a lifetime history of cancer, and to describe variation by cancer type/site among survivors.MethodsWe analyzed pooled 2015-2019 and 2021-2022 National Survey on Drug Use and Health (NSDUH) data of ...
Abstract Background and aims Psilocybin, a psychoactive compound found in fungi commonly referred to as “magic mushrooms,” is consumed for both spiritual and recreational purposes. However, psilocybin use in Puerto Rico remains understudied. This exploratory cross-sectional survey aimed to describe patterns of use, motivations for consumption, explanatory fa...
Prolonged grief disorder (PGD) affects approximately 10% of bereaved individuals and is now formally recognized in both the DSM-5-TR and ICD-11. Despite its prevalence, PGD often responds poorly to traditional therapeutic approaches. This manuscript outlines the protocol for an early-stage open-label feasibility trial investigating the use of psilocybin, a p...
Abstract Depression and anxiety affect one in five adults, with age affecting prevalence. While clinical trials suggest classic psychedelics (e.g., psilocybin, LSD) and non-classic psychedelics (e.g., MDMA, ketamine) may alleviate these symptoms, it remains unclear how these relationships function in naturalistic settings or how they vary across the lifespan...
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...
Abstract Repeated mild traumatic brain injury (RmTBI) can produce lasting cognitive, emotional, and social deficits (e.g., persistent post-concussion symptoms; PPCS). Despite the prevalence of RmTBI in sports, military, and domestic violence settings, effective treatments to alleviate the neurological consequences of RmTBI remain limited. Psilocybin, a serot...
Naturalistic psychedelic use can result in a range of difficulties that impair social, occupational, and other important areas of functioning. Yet, the prevalence, phenomenology, and etiology of these outcomes remain poorly understood. Recent qualitative research has shown that individuals with long-term difficulties after psychedelic use sometimes attribute...
Psilocybin is a psychoactive chemical compound that exerts its effects through the activation of serotonergic receptors. It occurs naturally in mushrooms of the genus Psilocybe. Despite its potential medical applications, this substance is regarded as a drug with no recognized medical use. Depression constitutes a psychiatric disorder of substantial global b...
People of color have been significantly underincluded in psychedelic-assisted therapy (PAT) research, despite facing challenges commonly addressed in PAT and often more severe symptoms. It may be the case that people of color are underincluded because PAT researchers have not used approaches designed to promote sample diversity. Community-engaged research (C...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
Today’s research highlights the therapeutic potential of the hallucinogen psilocybin in the treatment of pathologies associated with mood, cognitive, and affective dysregulation. These domains of function are regulated by the serotonergic system, which can be influenced by sex hormones, like estrogen and testosterone, and psychedelic compounds including psil...
