The New England journal of medicine
November 3, 2022
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
1,095 citations
A single 25 mg dose of psilocybin, but not 10 mg, reduced depression scores more than a 1 mg control dose over three weeks in adults with treatment-resistant depression. In this phase 2 trial, 233 participants were randomly assigned to 25 mg, 10 mg, or 1 mg of synthetic psilocybin with psychological support. The 25 mg group showed an average 12-point drop on the MADRS depression scale versus a 5.4-point drop in the 1 mg group, a significant difference. The 10 mg group did not differ significantly from control. Response and remission rates at three weeks supported the primary result, but sustained response at 12 weeks was not significantly different.
Journal of Affective Disorders
February 3, 2023
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
168 citations
Three weeks after a single dose, 25 mg of psilocybin, and to a lesser extent 10 mg, improved patient-reported measures of depression severity, anxiety, affect, and functioning in people with treatment-resistant depression. These findings extend the primary results from the largest randomized clinical trial of psilocybin for TRD, highlighting outcomes that matter to patients.
Journal of affective disorders
March 1, 2025
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
35 citations
In treatment-resistant depression, a single dose of 25 mg of psilocybin produced stronger correlations between certain psychedelic experiences and depression improvement three weeks later than lower doses. The intensity of psychedelic effects was dose-related, but scores for different doses overlapped considerably. At the 25 mg dose, dimensions of oceanic boundlessness and visual restructuralization, along with emotional breakthrough, showed the strongest correlations with reduced depression scores. The study does not establish causation and requires replication. The overlap in experience intensity across doses suggests unblinding to dose is less likely. Correlations between psychedelic experience and outcome indicate specificity in psilocybin's mechanism of action.
Frontiers in Psychiatry
August 2, 2021
Nicolas Langlitz, Erika Dyck, Milan Scheidegger et al.
35 citations
Psychedelics may act as non-specific amplifiers that help people reconnect with their values, or they might specifically promote liberal and anti-authoritarian views, as recent studies suggest. The return of psychedelics from counterculture to mainstream science has diversified their users and uses. This article argues for a moral psychopharmacology that brings pharmacological and neuroscientific research into conversation with historical and anthropological scholarship on the full range of moral and political views linked to psychedelic use. The work highlights the cultural plasticity of drug action and has implications for designing psychedelic therapies, while also questioning whether other psychoactive drugs have similarly rich moral and political dimensions.
Frontiers in Psychiatry
October 26, 2022
Tor-Morten Kvam, Ivar W Goksøyr, Lowan H. Stewart et al.
11 citations
A proof-of-principle, open-label clinical trial will test MDMA-assisted therapy for major depressive disorder. Twelve participants with a DSM-5 diagnosis of MDD will receive a flexible dose of MDMA during two dosing sessions over four weeks, each followed by three integration sessions. The primary outcome is change in depression severity measured by the MADRS scale from baseline to eight weeks after the second session. Secondary outcomes include functional impairment and safety measures such as adverse events and suicidality. The trial aims to inform larger studies and optimize the treatment protocol.
Neuroethics
April 1, 2025
Christopher Poppe, Daniel Villiger, Dimitris Repantis et al.
9 citations
Ethical problems in training for psychedelic therapy include the need for comprehensive training due to participant vulnerability, reliance on psychedelic experience without psychotherapeutic training, self-disclosure of personal psychedelic use, and guruism. Mitigation strategies include ethics codes and training, monitoring and control via video recording, requiring professional licensure and psychotherapy training for practitioners, and imposing a cooling-off period after therapists' personal psychedelic experiences to avoid a 'honeymoon' effect.
Psychological Medicine
January 1, 2025
Chiara Caporuscio, Christopher Poppe, Astrid Gieselmann et al.
9 citations
A scoping review of ethical issues in psychedelic-assisted therapy identifies seven key themes: safety and patient well-being, therapeutic relationships, informed consent, equity and access, research ethics, special contexts, and societal and cultural implications. The review systematically searched multiple databases for peer-reviewed studies on human participants and psychiatric patients, covering publications up to June 2025. The findings aim to inform further discussion and research to support safer and more ethical implementation of psychedelic-assisted treatments as they approach clinical use.
Current topics in behavioral neurosciences
November 8, 2024
Christopher Poppe, Dimitris Repantis
9 citations
This chapter surveys ethical issues in psychedelic-assisted treatments across clinical ethics, research ethics, and societal dimensions. In clinical settings, autonomy, shared decision-making, and informed consent are critical because patients in altered states are vulnerable, raising concerns about touch and suggestibility. The debate over hallucinogenic versus nonhallucinogenic psychedelics questions the necessity of altered states. Exceptional therapist training and end-of-life care contexts are also discussed. In research, inclusivity, equipoise, and expectation management are key, with unresolved questions about post-trial access. Finally, equitable access, justice for indigenous communities, and the effects of legalization and medicalization are pressing societal concerns amid the psychedelic renaissance.
Die Psychotherapie
February 9, 2024
Dimitris Repantis, Michael Koslowski, Sascha Benjamin Fink
4 citations
Clinical research on psychedelic-assisted therapy for mental disorders has resumed in recent years, with a steadily increasing number of studies and publications. This has raised many ethical questions that have not yet been sufficiently examined and answered. This article provides an overview of the state of clinical research and then addresses the central ethical issues arising from this particular form of therapy. Using current literature and examples from an ongoing study in Germany, ethical questions are examined in detail.
Journal of affective disorders
August 1, 2026
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
2 citations
In people with treatment-resistant depression receiving 25 mg psilocybin with monitoring and support, the therapeutic alliance before dosing had only weak correlations with improvement in depression scores at three weeks. Stronger correlations were seen with the intensity of the psychedelic experience itself, particularly emotional breakthrough and visual restructuring. Path analysis suggested that therapeutic alliance helped facilitate the psychedelic experience, but it was the psychedelic experience—not the alliance—that had stronger direct effects on clinical outcomes. The alliance's direct effect on antidepressant response was limited or absent.
Brain and behavior
June 1, 2026
Christopher Poppe, Liisa Lyck, Laura Bechtold et al.
1 citation
In people with treatment-resistant depression entering psychedelic clinical trials, motivations and expectations are complex and may shift over time. Interviews with 17 participants before screening for 5-MeO-DMT or psilocybin trials revealed two main themes: motivations (hope, demoralization, prior psychedelic experience, social reasons) and expectations (anticipated symptom reduction, perceived mechanisms of change, role of setting, and retrospective expectations). Many viewed trial participation as a last resort after chronic illness and failed treatments. In two cases, initially cautious expectations were later reinterpreted as stronger after participation. These findings suggest that expectancy should be systematically addressed in trial design, informed consent, and interpretation of outcomes.
Psychopharmacology
June 10, 2026
Julian Kirsch, C. Poppe, Anne Beck et al.
Most people with alcohol use disorder (AUD) are aware of psychedelic research and would be willing to try psychedelic therapy, but their openness depends heavily on expecting it to succeed. In a mixed-method study of 112 participants from two non-psychedelic clinical trials and 10 patients from addiction outpatient services, 62.5% knew about psychedelic research and 64.3% were willing to join a psychedelic therapy trial. Willingness was strongly linked to higher expectations of research success, not to age or knowledge alone. Interviews revealed a spectrum of attitudes shaped by perceived therapeutic potential, fears of addiction or loss of control, personal and societal experiences with substances, and media exposure. Expectation of benefit was central to openness.
Psychological Medicine
January 1, 2026
Ricarda Evens, Abdo Uyar, Emily Gosslau et al.
About 31% of people who had a distressing psychedelic experience that lasted beyond the acute phase met diagnostic criteria for post-traumatic stress disorder (PTSD). Avoidance during the acute experience predicted worse PTSD symptoms, while acceptance predicted milder symptoms. Post-traumatic growth was unrelated to the intensity of the challenge or avoidance but was linked to acceptance. Most participants sought help from online resources or friends, though psychotherapy was rated most helpful. The study targeted those with highly challenging experiences, so findings do not reflect prevalence among all psychedelic users.