Abstract Rationale and Objectives: Polysubstance use involving psychostimulants and opioids is increasingly prevalent and associated with elevated overdose risk, relapse vulnerability, and poor treatment outcomes. However, the neurobehavioral consequences of opioid-stimulant use remain poorly understood. We evaluated whether repeated methamphetamine-fentanyl...
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...
Introduction. Limitations of conventional treatments for depression and anxiety, particularly in treatment-resistant cases, have driven interest in alternative therapeutic approaches. Psilocybin, a serotonergic agonist with demonstrated effects on neuroplasticity and large-scale brain networks, has emerged as a promising therapeutic option. Materials and met...
Psilocybin-assisted therapy shows promise for depression, though current evidence relies on Phase 2 trials with notable methodological limitations. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating psilocybin-assisted therapy for major or treatment-resistant depression up to February 2024. We evaluated depre...
Aging is associated with chronic, low-grade inflammation (“inflammaging”), which contributes to neuropsychiatric and neurodegenerative disorders such as depression, Alzheimer’s disease, and Parkinson’s disease. Conventional pharmacotherapies often provide limited benefit in older adults and are further complicated by polypharmacy and drug-drug interactions. ...
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...
This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gai...
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulat...
Abstract Background: This case describes a substance-induced manic episode with psychotic features in which interaction with an AI (artificial intelligence) chatbot appeared to corroborate and reinforce the patient’s delusional thought content and to contradict medical advice. Excerpts from the patient’s interactions with the AI chatbot provide novel clinica...
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 ...
Meaning is a primary existential concern in those with advanced illnesses and functions as an important coping mechanism. Loss of meaning contributes to existential distress, and, in particular, may manifest as demoralization, a syndrome of poor coping that is associated with negative outcomes. Psychedelics are unique psychoactive compounds that, among other...
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...
Neuroplasticity refers to the ability of the brain to modify synaptic connections and reorganize neural circuits, underpinning cognitive function, emotional regulation, and recovery from injury. Recent advances have redefined adult neuroplasticity as more dynamic and therapeutically accessible than previously thought, spurring investigation into pharmacologi...
Background: Psilocybin is a psychoactive compound found in hallucinogenic mushrooms and is rapidly dephosphorylated in vivo to psilocin, its pharmacologically active metabolite. Despite the growing clinical and scientific interest in these substances, information regarding their interaction with cytochrome P450 (CYP450) enzymes remains scarce, raising concer...
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...
The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are: 1. Is a single psilocybin dose feasible to administer during postoperative hospitalization? 2. Is psilocybin safe in this patient po...
Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants wit...
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...
A key distinction among clinical trials on psilocybin treatments, for example, those targeting depression, has been whether the psilocybin dosing session is combined with bona fide psychotherapy or with what is referred to as “psychological support” (1-3). The most developed model of psychological support is the Compass Psychological Support Model (CPSM; 1)....
