Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. The current study sought expert recommendations on informed consent challenges, best practices and recommendations for supervised psilocybin experiences across various settings. Participants with psilocybin content...
Psychedelics a class of psychoactive compounds such as psilocybin, lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT) are undergoing a scientific renaissance. Studies since 2020 have shown their therapeutic promise in mental health treatment. This Commentary synthesizes historical usage, current neuroscientific and clinical evidence, and explores...
This paper follows 8 scientists who ventured into the world of psychedelics on a quest to find transformational pathways forward. Each have worked on aspects of global environmental change for decades, and observing environmental crises converging into a global polycrisis/metacrisis with genuine potential for collapse, we have all carried psychological burde...
Microdosing is a novel approach to the consumption of classic psychedelic substances, such as LSD (lysergic acid diethylamide) and psilocybin that emerged in recent years. Unlike traditional illicit substance use, which often seeks euphoric experiences, microdosing deliberately avoids such effects in pursuit of self-enhancement. This practice has grown in po...
Psychedelic- and substance-assisted therapies, including MDMA, psilocybin, and ketamine, are gaining attention for conditions such as PTSD and depression, yet their development and implementation remain largely concentrated in high-income settings. This graphical abstract summarizes the central argument of the commentary: while these interventions may hold r...
Psychedelic-assisted psychotherapy (PAP) has re-emerged over the past decade as a promising therapeutic approach for a range of mental health conditions, including treatment-resistant depression, post-traumatic stress disorder, anxiety associated with life-threatening illness, and substance use disorders. Substances such as psilocybin, MDMA, ketamine, and LS...
Psychedelic-assisted therapy (PAT) is increasingly investigated as a treatment for depression, post-traumatic stress disorder (PTSD), and substance use disorder. In the United States (US) and European Union, esketamine has been approved for the treatment of depression, while psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) have received Breakthrough T...
Laws to control drugs have been progressively introduced since the early twentieth century to reduce non-medical use and drug-associated harm. Restrictions on what are now deemed ‘controlled drugs’ and, in New Zealand, ‘prohibited plants’ unjustly impact both medical care and research. The impact on research has frequently been cited in reference to the use ...
Indigenous Peoples have cultivated and protected natural psychoactive medicines through ceremony, kinship, and spiritual responsibility across generations, yet their long-standing contributions have often been marginalized through extractive research, commercialization, and policy exclusion. It is Indigenous communities that have stewarded and gained experti...
Australia's reclassification of psilocybin as a Schedule 8 substance for treatment-resistant depression represents a significant shift in psychiatric policy. While this regulatory change positions Australia as a global leader in psychedelic medicine, its implementation has revealed substantial challenges. This article critically examines the regulatory, ethi...
Psychedelic-assisted therapy (PAT) has emerged as a promising and innovative approach to treating a range of mental health disorders, including depression, post-traumatic stress disorder (PTSD), and substance use disorders. Once sidelined due to regulatory bans and social stigma, psychedelics such as psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), lyse...
Psychedelic research is progressing at breakneck speed and is creating new challenges for drug developers, regulatory authorities, and legislators. Most “classic” psychedelics undergoing clinical investigation are C-I controlled drugs with perceived high potential for abuse and no medical use. These and next-generation psychedelic drug-candidates require sci...
Psilocybin has emerged as a promising therapeutic agent for psychiatric and neurological disorders. However, its legal status varies significantly across countries, creating barriers for clinical use and research. This paper provides an international overview of the regulatory landscape governing medical psilocybin, highlighting key legal restrictions, polic...
Czechia has recently approved the medical use of psilocybin, marking a pivotal shift in the country’s drug policy landscape. This development paves the way for regulated therapeutic applications of psilocybin within clinical settings, while simultaneously prompting a timely discussion on the potential uses of psychedelics beyond strictly medical contexts. Th...
Background Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics l...
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...
This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain ...
Although psychedelics were banned from medical research for about fifty years, recent early-phase studies indicate they may offer unique therapeutic benefits for various mental health and substance use disorders. When effective, psychedelic experiences often involve phenomena not typically observed in other medical or psychiatric interventions, such as a dim...
BACKGROUND: Recent years show an exponential increased interest ("renaissance") in the use of psychedelics for the treatment of mental disorders and broader. Some of these treatments, such as psilocybin for depression, are in the process of formal regulation by regulatory bodies in the US (FDA) and Europe (EMA), and as such on the brink of real-world impleme...