Psychedelics represent a potential breakthrough for treatment-resistant depression; however, the prolonged in-clinic monitoring required for compounds such as psilocybin and lysergic acid diethylamide is a logistical hurdle to widespread use. Intranasal mebufotenin (5-methoxy-N,N-dimethyltryptamine), a 5-hydroxytryptamine 1A (5-HT1A) and 5-HT2A agonist associated with brief psychedelic...
BMC Medical EthicsOctober 18, 2026Adrian Kind, Josephine Görke, Hannah Smirr et al.
Abstract Background Treatments with acute consciousness-altering effects, such as (es)ketamine, place patients in a state of heightened vulnerability with reduced capacity for self-advocacy and self-regulation. Since feeling safe is a precondition for consenting to begin, and remaining in, treatment, this raises distinct ethical demands on care. Which features of the setting enable patients to...
The contribution of patient support to psilocybin's antidepressant effects remains uncertain. Relationships between therapeutic alliance (Scale to Assess Therapeutic Relationship-Patient version; STAR-P), psychedelic experience (Five-Dimensional Altered States of Consciousness Questionnaire and Emotional Breakthrough Inventory; 5D-ASC and EBI) and clinical outcomes (Montgomery-Åsberg Depression...
Zusammenfassung Klassische Halluzinogene („Psychedelika“) wie Lysergsäurediethylamid (LSD), Psilocybin, N,N-Dimethyltryptamin (DMT) und 5-Methoxydimethyltryptamin (5-MeO-DMT) werden zurzeit wieder als potenzielle Behandlungsoptionen bei Substanzgebrauchsstörungen untersucht. Psychedelika entfalten ihre Wirkung über eine Aktivierung von serotonergen 5HT-2a Rezeptoren im zentralen Nervensystem,...
Psychedelic treatments hold significant therapeutic promise for various psychiatric conditions. However, their unique therapeutic setting with psychedelic substance dosing sessions presents a particular ethical issue concerning patient autonomy. This article explores the ethics of limiting personal autonomy and freedom of movement during dosing sessions due to concerns for physical safety....
The research, understanding, and implementation of psychedelic therapies is characterised by a layered complexity that arises from the dynamic interactions between pharmacological and extra-pharmacological factors, and the embeddedness of psychedelics within broader societal, legal, and regulatory systems ill-equipped to accommodate them. This complexity is compounded by an epistemic...
BACKGROUND: Alcohol use disorder (AUD) remains a major global health concern, with high morbidity and mortality and limited long-term treatment success. Psychedelic therapy has re-emerged as a potential novel intervention for AUD, yet little is known about how affected individuals perceive such treatments. METHODS: This mixed-method study explored attitudes and perceptions of psychedelic...
Expectations strongly shape participant experiences in clinical trials, contributing to placebo effects that complicate interpretation of outcomes. While quantitative tools exist to measure expectations, their subjective and multidimensional nature, especially for individuals with treatment-resistant depression (TRD), remains underexplored. This study aimed to explore the motivations and...
Zusammenfassung Psychedelika wie Psilocybin und LSD durchlaufen eine bemerkenswerte Geschichte, die von frühen psychiatrischen Anwendungen über den Freizeitgebrauch und die Prohibition in den 70er Jahre bis zur aktuellen Wiederentdeckung in klinischen Studien reicht. MDMA wird seit etwa 15 Jahren für die Behandlung der posttraumatischen Belastungsstörung evaluiert. In der Behandlung werden...
BACKGROUND: While clinical research on psychedelics often reports mild and transient side effects, broader survey studies indicate that a subset of users experiences lasting adverse mental health effects. This study investigated whether some of these meet diagnostic criteria for post-traumatic stress disorder (PTSD). METHODS: = 243) was conducted with individuals reporting distressing...
Psychedelic-assisted therapy (PAT) has typically been evaluated using conventional randomised controlled trials (RCTs), which assess treatment efficacy under highly controlled conditions. However, PAT constitutes a complex intervention, integrating pharmacological, psychotherapeutic and contextual elements that interact dynamically with patient experiences and healthcare settings. Conventional...
This Viewpoint describes the benefits of providing psychedelic treatment to persons with psychiatric conditions as life-preserving care before physician-assisted death.
Psychedelic substances exhibit complex interactions with the 'set and setting' of use, that is, the mental state of the user and the environment in which a psychedelic experience takes place. Despite these contextual variables' known importance, psychedelic research has lacked methodological rigor in reporting extra-pharmacological factors. This study aimed to generate consensus-based...
Abstract In the present paper, we analyze the ethical issues in training for psychedelic therapy and discuss mitigation strategies for these issues. Specifically, after describing models of psychedelic training, we describe four problems of psychedelic training: (1) the imperative for comprehensive training due to vulnerability of participants, (2) psychedelic but not psychotherapeutic...
To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with...
Abstract Based on promising preliminary results from clinical trials, it seems likely that psychedelic substances (classic serotonergic psychedelics, such as psilocybin, and entactogens, such as MDMA) will be introduced into psychiatry as psychedelic-assisted therapy. This also raises a range of ethical questions that urgently need to be addressed before widespread roll-out in society. This...
In this chapter, we provide an overview of ethical aspects of psychedelic-assisted treatments in the areas of clinical ethics, research ethics, and at the intersection of psychedelic medicine and society. In contrast to earlier psychedelic research, nowadays medical ethics have been firmly established as a discipline regulating patient-physician relationships which highlight the importance of...
ZUSAMMENFASSUNGNeben den klassischen Psychedelika, z. B. Psilocybin, werden wieder vermehrt andere Substanzen wie 3,4-Methylendioxy-N-methylamphetamin (MDMA) erforscht. Das Entaktogen („innerlich berührend“) ist in den USA nur noch wenige Schritte von einer möglichen Zulassung zur Behandlung der posttraumatischen Belastungsstörung entfernt. Dieser Artikel soll einen Überblick über die Wirkung,...
Zusammenfassung Hintergrund In den letzten Jahren wurde die klinische Forschung zu Psychedelika-gestützter Therapie psychischer Störungen wieder aufgenommen, mit einer stetig steigenden Zahl von Studien und Publikationen. Dabei sind viele ethische Fragen aufgekommen, die noch nicht ausreichend untersucht und beantwortet wurden. Ziel Dieser Beitrag gibt einen Überblick zum Stand der klinischen...
Three weeks after dosing, psilocybin 25 mg and, to a lesser degree, 10 mg improved measures of patient-reported depression severity, anxiety, affect, and functioning. These results extend the primary findings from the largest randomised clinical trial of psilocybin for TRD to examine other outcomes that are of importance to patients.
Psilocybin is being studied for use in treatment-resistant depression. In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the...
Background Major depressive disorder (MDD) is a world-leading cause of disability. The available treatments are not effective in all patients, and there is a significant need for more effective treatment options. Here we present the protocol for an investigator-initiated and publicly funded trial of MDMA-assisted therapy (MDMA-AT) for MDD. This single-site, open-label study investigates the...
The revival of psychedelic research coincided and more recently conjoined with psychopharmacological research on how drugs affect moral judgments and behaviors. This article makes the case for a moral psychopharmacology of psychedelics that examines whether psychedelics serve as non-specific amplifiers that enable subjects to (re-)connect with their values, or whether they promote specific...