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...
Psilocybin is a naturally occurring hallucinogen known to produce alterations in perception, cognition, and autonomic function through its effects on central serotonergic pathways. Products marketed as “mushroom” formulations may contain psilocybin or related psychoactive compounds despite ambiguous labeling and limited regulatory clarity, creating diagnosti...
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...
Classic psychedelics are increasingly studied as potential treatments for different psychiatric disorders. Current research protocols often require patients to discontinue antidepressants (ADs) for at least 2 weeks before psychedelic administration to decrease the risk of serotonin syndrome and limit their effect on efficacy and the acute subjective effects ...
Psychedelic drugs, known for their perception-altering properties, are gaining popularity in the treatment of mental health and pain disorders. As exploratory studies demonstrate clinical efficacy with few adverse events, it is expected that more patients will ingest psychedelic drugs. For therapeutic reasons, as with any drug, anaesthesiologists must be awa...
Known for their capacity to alter perception and consciousness, psychedelics are increasingly being explored for therapeutic applications in treating conditions such chronic pain, major depressive disorder, and post-traumatic stress disorder.1,2 Despite historical stigmas and legal restrictions, recent changes in legislation and the United States Food and Dr...
One of the main causes of misery and incapacity is chronic pain, which is frequently linked to psychological issues. Psychedelic substances are drugs that can exert a psychological effect on patients. Psychedelic drugs like lysergic acid diethylamide (LSD) and psilocybin, exert their action mainly via activation of the serotonin-2A (5-HT2A).1 In a trial to u...
During the 1960s, several studies were conducted to test the therapeutic effects of hallucinogenic drugs, also known as psychedelics, on various disorders, such as major depressive disorder (MDD). However, the non-medical use of these substances became rampant due to their hallucinogenic effects, leading to their classification as narcotics in numerous count...
Diverse symptomatology makes Fragile X Syndrome (FXS) difficult to treat, and currently there are no approved prevention or treatment methods for FXS. Current therapies, including pharmaceutical and behavioural interventions, offer a patchwork of solutions that have limited efficacy and high toxicity. The current study aims to examine psilocybin as a safe tr...
Psychedelics like LSD (Lysergic acid diethylamide) and psilocybin are known to modulate perceptual modalities due to the activation of mostly serotonin receptors in specific cortical (e.g., visual cortex) and subcortical (e.g., thalamus) regions of the brain. In the visual domain, these psychedelic modulations often result in peculiar disturbances of viewed ...
Introduction: Amid a lack of effective chronic pain treatments, psychedelics have gained attention as a potential solution, although their Schedule 1 classification poses challenges. Psychedelics, such as lysergic acid diethylamide (LSD) and psilocybin, have gained popularity as alternatives and adjuncts for chronic pain treatment. Studies suggest that they ...
There has been little research on the effects of psychedelics on menstrual and reproductive function, though anecdotal evidence suggests that these compounds may have striking effects on menstrual function in at least a subset of users. Social media and word of mouth were used to seek out individuals who had a history of changes in menstrual function followi...
The serotonergic psychedelic psilocybin shows efficacy in treating neuropsychiatric disorders, though the mechanism(s) underlying its therapeutic effects remain unclear. We show that a similar psychedelic tryptamine, N,N-dipropyltryptamine (DPT), completely prevents audiogenic seizures (AGS) in an Fmr1 knockout mouse model of fragile X syndrome at a 10 mg/kg...
Back to table of contents Previous article Next article Annual MeetingFull AccessExperts Offer Tips on Talking With Patients About PsychedelicsTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:28 Jun 2023https://doi.org/10.1176/appi.pn.2023.07.7.51AbstractPsychedelics differ from one another in their mechanism of action and po...
Back to table of contents Previous article Next article Annual MeetingFull AccessPsychedelic Therapy Requires Enhanced Consent DiscussionsNick ZagorskiNick ZagorskiPublished Online:28 Jun 2023https://doi.org/10.1176/appi.pn.2023.07.7.46AbstractThe presenters at an Annual Meeting session cautioned that patients pursuing psychedelic-assisted psychotherapy will...
Psychedelic-assisted therapy (PAT) may treat various mental health conditions. Despite its promising therapeutic signal across mental health outcomes, less attention is paid on its potential to provide therapeutic benefits across complex medical situations within rehabilitation medicine. Persons with spinal cord injury (SCI) have a high prevalence of treatme...
Welcome to the April edition of Going on Trial, a monthly newsletter covering clinical trials and drug development for autism and related conditions. In this issue, we're talking about a serotonin agonist's path to trial for autism, debate around a trial of psilocybin for fragile X syndrome and an analysis of placebo responses in a clinical trial of the vaso...
The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many...