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...
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participant...
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...
Psychedelic clinical research is expanding rapidly. This review analyses the state and trends in psychedelic clinical trial registrations. A systematic search of ClinicalTrials.Gov was conducted on 11 November 2024, to identify registered interventional trials investigating (therapeutic) effects of serotonergic psychedelics (e.g. lysergic acid diethylamide [...
ROLE OF PSYCHEDELICS IN PSYCHIATRY: A TRUE THERAPEUTIC REVOLUTION OR A TREND? Psychedelics, long marginalized, are now gaining renewed interest in psychiatry for their therapeutic potential. Substances like psilocybin, LSD, and MDMA are being studied for treating conditions such as treatment-resistant depression, post-traumatic stress disorder (PTSD), and an...
Introduction In recent years, psychiatry has witnessed a renaissance in the investigation of psychedelic compounds, a broad class of psychoactive substances that induce altered states of consciousness, often characterized by changes in perception, mood, and cognition, which were largely shelved following regulatory crackdowns in the 1970s. The renewed intere...
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...
The resurgence of psychedelic-assisted psychotherapy marks a pivotal evolution in mental health treatment, challenging traditional paradigms by integrating compounds such as psilocybin, LSD, MDMA, and ketamine into clinical practice. Historically marginalized due to regulatory and societal concerns, these agents are now gaining recognition for their unique n...
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 ...
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...
AbstractAlcohol use disorder (AUD) has devastating effects, and its prevalence in the US is growing. It is therefore important to examine multiple avenues for successful cessation and continued abstinence. Disulfiram, oral naltrexone, naltrexone IM, and acamprosate are currently the only four medications approved for the treatment of AUD by the FDA. This rev...
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 ...
Abstract The potential of psychedelic substances to treat mental illness is of significant clinical and societal interest, leading to academic and industry-based research to test their effects. Partly, such research was conducted to fulfil requirements of government agencies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FD...
Psilocybin, a tryptamine-derived alkaloid, has been granted Breakthrough Therapy designation by the U.S. FDA for treatment-resistant depression, underscoring its clinical importance. Therefore, sustainable and economic production is urgently needed. Manufacturing of psilocybin in Escherichia coli has drawn great attention. However, due to the low expression ...
There are substantial differences between the current FDA and research-driven approach to psychedelic use in Western cultures and traditional uses among Indigenous peoples. While the research-driven, evidence-based approach to identifying risks and benefits for particular conditions used in the United States and elsewhere helps ensure safety and efficacy, th...
Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approx...
Psychedelic science is growing at a rapid pace, and as evidence accrues, we will most likely see authorization of the use of substances such as psilocybin and MDMA augmenting the effects of psychotherapy in the coming years. Lykos therapeutics (previously called MAPS PBC) recently filed a New Drug Application to the FDA in the US and expects to be able to of...
