The therapeutic benefits of psychedelics for neuropsychiatric conditions have gathered significant attention in Europe and around the world, with treatments using psilocybin, MDMA, and ketamine as notable examples. However, the mind-altering effects of these substances, and the complexity of their regulatory frameworks, both within and outside of therapeutic use, imply careful clinical...
Hallucinogen Persisting Perception Disorder (HPPD) is a condition affecting 1-5% of psychedelic users, with higher prevalence observed among recurrentLSD consumers and synthetic cannabinoid users [1]. The disorder is characterised by persistent visual disturbances including palinopsia and visual snow, along with dissociative symptoms, which have been neurobiologically linked to 5-HT2A receptor...
Background: Serotonergic psychedelics induce their psychoactive effects by stimulating the brain’s serotonin 2A receptor (5-HT2AR). In humans, a cerebral 5-HT2AR occupancy of ≥60% is required to elicit a profound psychedelic experience with psilocybin [1] and for pigs, a dose corresponding to ∼65% 5-HT2AR occupancy elicits headshakes [2]. We posit that in order to assess biochemical and...
This article describes the Swiss limited access program for psychedelic/3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy. The Swiss Federal Office of Public Health can issue authorizations for the limited medical use of otherwise prohibited substances. To be eligible, patients suffer from a mostly incurable disease, the prohibited substance can alleviate the suffering, and there are no...
There is a growing body of clinical research on the therapeutic potential of psychedelics for the treatment of mental health disorders, notably depression. Accordingly, the new revision of the European Medicines Agency guideline on the clinical investigation of products for depression will incorporate a section covering specific regulatory recommendations for the design of studies with...
This study investigated the effects of a single high-dose of psilocybin on personality traits in psychedelic-naïve healthy volunteers. These data originate from a larger within-subjects fixed-order design trial, where a single high dose of psilocybin (25 mg) was administered in a psychologically supportive setting and was compared against a (one-month) prior, 1 mg 'placebo' dose. Personality...
Psychedelic drugs including psilocybin and LSD are undergoing clinical trials for a range of psychiatric and neurological conditions, and have particularly shown substantial promise in phase 2 studies of depression. In this article we outline key knowledge gaps that may be imperative for a successful implementation of psychedelic drugs as medicines as identified by members of the European...
Psilocybin is being studied for its therapeutic potential in various mental health disorders, such as depression, anxiety, and addiction. Initial studies suggested that psilocybin is generally safe when used under controlled conditions, but more research is needed to better understand its safety profile. We report safety pharmacology data from a pooled analysis of three randomized crossover...
Classical psychedelic drugs, e.g., psilocybin and LSD, stimulate the serotonin 2A receptor (5-HT2AR) and have recently been intensely investigated for their clinical effects in various brain disorders. At the ECNP "New Frontiers meeting" in March 2023, scientific experts in psychedelics met to identify key knowledge gaps in the mechanism of action of psychedelics as investigated using...
The serotonergic psychedelic psilocybin acutely induces changes in emotional states. However, it remains unresolved whether psilocybin acutely modulates amygdala reactivity to emotions, a brain region critically involved in emotion processing. Using functional magnetic resonance imaging (fMRI), we examined in 26 healthy individuals whether amygdala responses to angry, fearful and neutral faces...
ADHD in adulthood is often overlooked, which negatively affects the individual's well-being. First-line pharmacological interventions are effective in many ADHD patients, relieving symptoms rapidly. However, there seems to be a proportion of individuals who discontinue, or fail to respond to these treatments. For these individuals, alternative treatment options should be explored. A...
Psychedelics such as psilocybin have recently gained remarkable interest in both the specialist literature and the lay press because studies suggest that these substances may have great therapeutic potential in various psychiatric disorders, including major depression. However, clinical trials with psychedelic drugs pose particular methodological challenges to researchers, some of which differ...