Psychedelic Medicine
February 16, 2023
Zachary Skiles, Noa Eaton, Lisa Fredenburg et al.
49 citations
Most psychedelic therapists in a Usona Institute trial for psilocybin and major depressive disorder had personal experience with psychedelics: 88% had used at least one serotonergic psychedelic, most commonly psilocybin (81%), with a median of 2–10 uses and last use 6–12 months before the survey. The sample was predominantly white, female, and held doctoral degrees. All endorsed favorable views of psilocybin therapy. Experiential learning is common in psychotherapy but not psychiatry, placing psychedelic therapy between two traditions. The study was limited by a low response rate (22%) and lack of diversity. These first data on professionals' personal use inform the debate on whether such experience aids competency or introduces bias.
Psychedelic Medicine
August 18, 2023
15 citations
The therapeutic alliance—the cooperative connection between clients and providers—is a strong predictor of outcomes across many forms of psychotherapy, but its role in psychedelic-assisted therapy (PAT) has been largely overlooked. Only two publications directly address the alliance in PAT, despite years of recommendations emphasizing it. Adding alliance measures to PAT trials is low-cost and feasible, and clinicians can improve the alliance through simple behaviors like respecting patient autonomy, listening, and addressing practical concerns. Greater focus on the alliance could clarify how PAT works and boost its effectiveness, potentially reducing human suffering more efficiently.
Psychedelic Medicine
October 28, 2022
Bruna Giribaldi, Sandeep M. Nayak, Bilal A. Bari et al.
15 citations
A Bayesian reanalysis of a trial comparing psilocybin (25 mg) to escitalopram (20 mg) over 6 weeks in 59 patients with major depressive disorder found that psilocybin outperformed escitalopram on three of four depression scales, though evidence was not uniformly clinically meaningful. Using skeptical priors that bias results toward zero, the analysis showed strong to extremely strong evidence favoring psilocybin on the BDI-1A, MADRS, and HAMD-17, while evidence on the primary outcome (QIDS SR-16) was indeterminate. For clinically meaningful superiority, evidence was moderate against it for the QIDS SR-16 but moderate to strong for the MADRS and HAMD-17. Psilocybin showed extremely strong evidence of noninferiority to escitalopram across all scales. The findings support further research on psilocybin's relative efficacy.
Psychedelic Medicine
May 16, 2025
Roland R. Griffiths, William A. Richards, Robert L. Jesse et al.
14 citations
In clergy from various world religions who had never used psychedelics, two supported psilocybin sessions (20 mg/70 kg, then 20 or 30 mg/70 kg) led to sustained positive changes in religious practices, attitudes about their religion, and effectiveness as a religious leader, as well as in non-religious attitudes, moods, and behavior, compared with a waitlist control group. At 16‑month follow‑up, 96% rated at least one experience among the top five most spiritually significant of their lives, 42% rated it the single most profound, and 79% reported positive effects on daily sense of the sacred. No serious adverse events occurred, though 46% rated an experience among the top five most psychologically challenging of their lives.
Psychedelic Medicine
February 7, 2025
12 citations
Psychological support in psychedelic clinical trials is poorly defined, with little agreement on its essential components, boundaries, or limits. This perspective article proposes using the microskills framework from Ivey et al. (2021) to distinguish psychological support from psychotherapy by focusing on specific communication units and behaviors. The authors argue that trial protocols and treatment manuals should clearly define which psychosocial interventions and behaviors are permitted, to prevent interventions that exceed the trial's mandate or the session monitor's regulatory scope of practice.
Psychedelic Medicine
May 19, 2023
Mollie Pleet, Joshua White, Joseph A. Zamaria et al.
12 citations
A helpline for people having difficult psychedelic experiences may reduce distress and prevent emergency calls. Analysis of 884 callers to a psychedelic helpline found that 65.9% reported the call de-escalated their psychological distress. Without the helpline, 29.3% said they might have been harmed, 12.5% might have called 911, and 10.8% might have gone to the emergency room. The findings suggest that such helplines can avert harmful outcomes and reduce the burden on emergency medical services.
Psychedelic Medicine
August 30, 2023
Samantha Hilbert, David S. Mathai, Nathan D. Sepeda et al.
10 citations
Dissociatives like dextromethorphan may have clinical applications when used in supportive settings similar to those in psychedelic research, which prioritize optimizing psychologically valuable drug experiences. The analysis suggests that such contexts could enhance therapeutic outcomes.
Psychedelic Medicine
January 20, 2025
Marianna Graziosi, Gabrielle Agin-Liebes, Mary P Cosimano et al.
9 citations
Psilocybin and other serotonergic psychedelics are used in research settings with safety measures including controlled environments, staff presence, screening, and psychoeducation. An analysis of study materials from psilocybin trials over the past two decades found that psychoeducation documents varied but commonly emphasized biological and physical safety, psychological safety and well-being, aspects of setting, and the potential for expectancies. The materials prioritized biological and psychological safety across all sites. The authors also identified elements unrelated to safety that may contribute to participant expectancies and suggest these extrapharmacological factors be studied systematically to maximize safety while minimizing extraneous expectancies.
Psychedelic Medicine
August 18, 2023
Claudia Lex, Antonio F. Pagán, Jair C. Soares et al.
9 citations
Medical students hold generally positive attitudes toward psychedelic-assisted therapy, but their attitudes are significantly more favorable when the term "psilocybin" is used instead of "magic mushrooms." Personal experience with psychedelics is linked to more positive attitudes, beliefs, and higher self-rated knowledge. Attitudes and beliefs are stronger predictors of willingness to recommend psychedelic-assisted therapy, if FDA approved, than personal experience alone. The findings suggest that using the term "psilocybin" may be preferable in research and educational contexts.
Psychedelic Medicine
June 1, 2023
Praachi Tiwari, Andrea Berghella, Ceyda Sayalı et al.
9 citations
Classic psychedelics may treat mood and substance use disorders by reversing learned helplessness, a well-studied phenomenon across mammals. The neural circuits underlying resilience to learned helplessness, including the dorsal raphe nucleus, overlap with those activated by psychedelics. Preclinical data show psychedelics improve performance in rodent behavioral despair tasks, supporting this hypothesis. The learned helplessness paradigm offers a robust model for investigating psychedelic mechanisms across behavioral, neurobiological, and clinical levels, potentially explaining transdiagnostic therapeutic effects.
Psychedelic Medicine
November 18, 2024
Shakila Meshkat, Erica Kaczmarek, Zoe Doyle et al.
8 citations
In a small subgroup analysis of four adults with treatment-resistant depression associated with bipolar II disorder, two 25 mg doses of psilocybin combined with psychotherapy were associated with reductions in depressive symptoms. The average depression score on the Montgomery–Åsberg Depression Rating Scale dropped from 32.5 at baseline to 20.3 two weeks after the first dose, and to 19 two weeks after the second dose; at six months the average score was 21.3. Mania ratings remained stable, and no mania, hypomania, or psychosis occurred. The authors suggest psilocybin may improve depressive symptoms in bipolar II disorder but call for larger studies to confirm the findings.
Psychedelic Medicine
May 8, 2024
Susanna Myers, John Guy, Anthony L. Back et al.
7 citations
A research team developing a group retreat-based psilocybin-assisted therapy trial created initial practice guidelines for ethical and supportive facilitator use of touch. After two unexpected touch-related experiences during the first three retreats, the guidelines were iterated. The revised guidelines specify acceptable practices to ensure participant safety and a supportive therapeutic experience. The primary goal is to create a haptic experience that reinforces participants' sense of safety and supports their own experience during the psilocybin session. A secondary goal is to help facilitators maintain therapeutic boundaries while responding to participant experiences with empathy and openness.
Psychedelic Medicine
December 1, 2023
Julia Malicki, Amelia Baltes, Christopher R. Nicholas et al.
7 citations
A clinical trial found that giving psilocybin together with buprenorphine to people with opioid use disorder was safely tolerated and did not interfere with buprenorphine's effectiveness or psilocybin's subjective effects. The study faced feasibility challenges that required changes to the participant pool and eligibility rules, along with strategies to improve accessibility, reduce burden, and increase generalizability.
Psychedelic Medicine
April 22, 2025
Sean M Viña
6 citations
Lifetime use of psychedelics such as psilocybin, LSD, MDMA, and DMT is linked to reduced psychological distress from internalized stigma about seeking mental health care, but this association varies by gender and race/ethnicity. Analyzing data from the National Survey of Drug Use (2008–2019) with a weighted sample of 458,372, the study found that stigma is statistically associated with higher distress overall. For White men, psychedelic use (especially LSD and DMT) showed stronger links to lower stigma-related distress, whereas these benefits appeared weaker for other groups, including women and people of color. The authors caution that the direction and mechanisms remain unclear and that minority groups may not experience the same level of benefit.
Psychedelic Medicine
November 26, 2024
Nadav Liam Modlin, Tyler McPhee, Nira Zazon et al.
5 citations
People who use psychedelics and attend integration groups report that these groups provide essential community support and help process psychedelic experiences, but also face challenges such as managing group dynamics and ensuring facilitators are adequately trained. Three main themes emerged: reasons for attending, utility of the groups, and adverse factors affecting experience. While integration groups can reduce some risks of unregulated psychedelic use, research is needed to develop standardized protocols and facilitator training to improve their safety and effectiveness.
Psychedelic Medicine
February 28, 2024
Dana DiRenzo, Jamie Perin, Erika Darrah et al.
4 citations
A preliminary study suggests that psilocybin may cause a temporary increase in cytokine production within one week after administration, but this effect is not consistent across different patient populations. The findings indicate that peripheral cytokine production is possibly altered by psilocybin.
Psychedelic Medicine
September 6, 2023
Marc J. Weintraub, Jessica Jeffrey, Charles S. Grob et al.
4 citations
A trial is planned to gather initial evidence on whether combining psilocybin with cognitive behavioral therapy is feasible, safe, acceptable, and has psychosocial benefits for people with major depressive disorder. The results will guide larger randomized trials to test this combined treatment's effects and explore how it might work through changes in thinking and emotion. The trial is registered at ClinicalTrials.gov with ID NCT05227612.
Psychedelic Medicine
November 25, 2024
Noah D. Gold, Broc A. Pagni, Petros Petridis et al.
3 citations
Psilocybin-assisted therapy may shift personal values in people with alcohol use disorder, specifically increasing Conservation—a value domain encompassing security and tradition. In a phase II trial, 93 participants received psychotherapy plus either psilocybin or an active placebo. Those given psilocybin showed significant increases in Conservation, security, and tradition values after treatment, while the placebo group did not. Certain features of the acute psychedelic experience, such as feelings of ineffability and reduced vigilance, correlated with these value changes. However, the shifts in values were not linked to changes in drinking behavior, suggesting that value modification alone does not drive reductions in alcohol use.
Psychedelic Medicine
February 3, 2026
Anton T. Gregersen, Tobias Whelan, Caroline T. Golden et al.
2 citations
Psilocybin, a serotonergic psychedelic, impaired short-term learning and unlearning speeds in rats performing a three-choice visual reversal learning task, though exploratory analysis suggested possible long-term enhancements in learning dynamics. Only five of sixteen Long-Evans rats (31%) successfully completed all six reversal protocols, demonstrating significant learning and unlearning over time. Computational modeling showed low learning rates with no significant differences between psilocybin and placebo conditions on any parameters. The findings indicate a nuanced effect of psilocybin on cognitive flexibility, with potential relevance for its use in neuropsychiatric disorders, but further research is needed on long-term outcomes.
Psychedelic Medicine
January 21, 2025
Maria Helha Fernandes-Nascimento, Karine Viana-Ferreira, André Brooking Negrão
2 citations
A bibliometric analysis of 853 publications from 1963 to 2023 shows that research on psilocybin for mental disorders has grown rapidly, with a 52% increase between 2016 and 2023. Publications come from five continents but are concentrated in high-development countries like the United States and United Kingdom. Depression appears most frequently in keyword analyses. Meta-analyses indicate psilocybin is effective for depression, anxiety, and substance use disorders, though the authors call for more randomized clinical trials to confirm safe and effective use.
Psychedelic Medicine
February 28, 2024
Joshua Woolley, Amanda E. Downey, Ellen Bradley et al.
2 citations
A risk stratification tool is proposed to help decide whether individuals with a family history of bipolar disorder should be included in psilocybin therapy trials. The authors argue for caution due to the potential for serious adverse events, but they recommend against outright exclusion. The tool allows for more nuanced inclusion and exclusion criteria, balancing the need for effective treatments against safety concerns.
Psychedelic Medicine
March 10, 2026
Amy Lehrner, Miryam Sperka, Lauren Lepow et al.
1 citation
MDMA-assisted therapy for post-traumatic stress disorder has shown strong clinical effects, high response rates, and low dropout when using a principle-guided, patient-directed model that includes nondrug preparatory and integrative sessions. This perspective argues that embedding MDMA into highly structured, manualized cognitive-behavioral treatment protocols may misapprehend the therapy's synergistic nature, blunt its transformative effects, and potentially cause harm. The field should prioritize research on real-world evidence, treatment optimization, and mechanisms of action of this distinct patient-directed model rather than immediately adapting existing protocols.
Psychedelic Medicine
January 18, 2026
Anthony L. Back, Bonnie A. Mcgregor, Leslie Lazar Thorn et al.
1 citation
A group retreat model of psilocybin therapy for people with metastatic cancer and anxiety or depression was safe and well tolerated. Fifty-two participants attended a 3-day retreat with 25 mg psilocybin, supported by virtual and in-person sessions. No episodes of unattended distress occurred during the psilocybin sessions. Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale, decreased by an average of 7.3 points from baseline to 28 days after the retreat, a statistically significant reduction. The findings suggest that a group configuration of eight participants with four core facilitators can be safe for future studies in people with serious medical illness.
Psychedelic Medicine
December 23, 2025
Anthony L. Back, Bonnie A. Mcgregor, Lindsay Billingsley et al.
1 citation
A group facilitation model for psilocybin therapy, developed for an FDA-approved Phase 1 to 2 clinical trial, draws on anthropological studies of ritual, specifically rites of passage, to structure a secular retreat for people with metastatic cancer experiencing anxiety or depression. The model uses three phases: separation (preparation), liminal (psilocybin dosing session), and reincorporation (integration). Ritual functions psychologically to support emotional regulation and meaning-making, and communally to embed individual experience in shared intention and care. This is the first FDA-approved clinical trial of a secular ritual-based group facilitation model for psychedelic therapy with empirically demonstrated safety and efficacy outcomes.
Psychedelic Medicine
November 27, 2025
1 citation
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