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...
Preliminary evidence suggests that psychedelic-assisted therapy-the enhancement of psychotherapy with psychedelics such as 3,4-methylenedioxymethamphet-amine (MDMA) and psilocybin-may be efficacious for depression, posttraumatic stress disorder, substance use disorders, and other conditions. Therapeutic psychedelic research is advancing steadily, with psiloc...
This study presents the development and validation of a high-performance liquid chromatography method with diode array detection (HPLC-DAD) for determining the content of tryptamines in methanolic extracts of dried fruiting bodies of mushrooms belonging to species of the Psilocybe genus. The objective is to initiate the assessment of tryptamine content in fu...
There is notable controversy about the role of psychotherapy in clinical trials of psychedelic-assisted therapy (PAT). This heated and perpetually evolving debate informs questions such as how much therapy should accompany a psychedelic intervention (Marseille et al., 2022), what type of therapy most effectively complements psychedelic administration (Cavarr...
Depressive disorders present an enormous global public health burden. A notable treatment gap exists between the prevalence of depression and our ability to provide rapid-acting, effective treatment that achieves remission. Brexanolone and zuranolone, the first US Food and Drug Administration-approved drugs for postpartum depression, signify a critical advan...
Background and objectivePsilocybin is currently being extensively studied as a potential therapeutic agent for multiple psychiatric disorders. Here, a systematic literature review of all published pharmacokinetic data on the pharmacologically active metabolite of psilocybin, psilocin, is presented.MethodsThe review includes clinical studies that reported pha...
As psilocybin awaits approval by the Food and Drug Administration (FDA), scholars debate whether psychedelic-assisted psychotherapy should be required when prescribing this medicine. Here, we report the case of a patient who underwent a psilocybin experience without psychedelic-assisted psychotherapy, resulting in inpatient psychiatric admission. This case u...
The recent surge in psychedelic-assisted therapy (PAT) research and anticipated Food and Drug Administration (FDA) approval of MDMA (methylenedioxymethamphetamine) and psilocybin treatments has bro...
There is increasing interest in establishing psychedelic research programs at academic medical centers. However, psychedelics are intensely psychoactive, carry considerable sociopolitical baggage, and most are Schedule I drugs, creating significant potential impediments to implementation. There is little formal guidance for investigators on navigating the co...
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...
The high therapeutic potential of psilocybin, a prodrug of the psychotropic psilocin, holds great promise for the treatment of mental disorders such as therapy-refractory depression, alcohol use disorder and anorexia nervosa. Psilocybin has been designated a 'Breakthrough Therapy' by the US Food and Drug Administration, and therefore a sustainable production...
This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the f...
Psychedelics (e.g., 3,4-Methylenedioxymethamphetamine [MDMA], lysergic acid diethylamide [LSD], psilocybin) are molecules that have the potential to produce rapid therapeutic effects when paired with psychotherapy. Randomized clinical trials of psychedelic-assisted psychotherapy (PAT) have shown promising results for post-traumatic stress disorder (PTSD), de...
The recent review of a new drug application for MDMA-assisted therapy for post-traumatic stress disorder by the United States’ Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psi...
The recent review of a new drug application for MDMA-assisted therapy for post-traumatic stress disorder by the United States’ Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psi...
The recent review of a new drug application for MDMA-assisted therapy for post-traumatic stress disorder by the United States’ Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psi...
There is an urgent need to develop better treatments for mental health conditions that affect one in every eight people in the world. To combat this concern, psychedelic drugs have been combined with psychotherapy and studied in clinical trials in the United States and Europe. Psychedelics are hallucinogenic drugs that alter brain activity and facilitate alt...
Psychedelic drug therapy has gained prominence for its potential in treating various mental health conditions, including depression, post-traumatic stress disorder (PTSD), and anxiety. Psychedelic treatment differs from conventional psychiatric approaches in mode of action, legal status, and treatment approach. This work delves into the therapeutic potential...
IntroductionThe recreational use of psilocybin or psilocin-containing products, a chemical found naturally in certain mushroom species, is on the rise across the United States. Several cases of serious clinical effects related to mushroom-containing products have recently been reported to the Food and Drug Administration (FDA). The emergence of these new pro...
With its catchy title, historian Benjamin Breen's Tripping on Utopia brings together controversial findings about the human mind, social engineering, and professional responsibility. He delineates the time frame and focus of an inquiry into psychoactive drug research by stating that “Timothy Leary and the Baby Boomers did not usher in the first psychedelic e...
