Cancer
December 18, 2023
Manish Agrawal, Yvan Beaussant, Sarah Shnayder et al.
73 citations
A single 25-mg dose of psilocybin, administered alongside one-to-one and group therapeutic support, was safe and feasible for patients with curable and noncurable cancer who also had major depressive disorder. In a phase 2 open-label trial with 30 participants, no serious adverse events or suicidality occurred, and mild side effects like nausea and headache were as expected. Depression severity scores dropped by an average of 19.1 points from baseline to eight weeks after treatment. Eighty percent of participants showed a sustained response, and half achieved full remission of depressive symptoms by week one that lasted for eight weeks. The group-oriented format and compact delivery in a community cancer center may add to therapeutic gains.
Journal of affective disorders
February 15, 2023
Sarah Shnayder, Rezvan Ameli, Ninet Sinaii et al.
67 citations
Psilocybin-assisted therapy improved psycho-social-spiritual well-being in cancer patients with major depressive disorder, as measured by the NIH-HEALS. In a Phase II open-label trial, 30 participants received 25 mg of psilocybin with group preparation and integration sessions. NIH-HEALS scores increased significantly after treatment, with gains in all three factors: Connection (12.7%), Reflection & Introspection (7.7%), and Trust & Acceptance (22.4%). Improvements appeared by day 1 and persisted through 8 weeks. The study lacked a control group, relied on self-reports, and had a small, limited sample, restricting generalizability. The results suggest that Connection, Reflection & Introspection, and Trust & Acceptance are key elements of psycho-social-spiritual healing in this context.
JAMA Oncology
April 13, 2023
Manish Agrawal, Ezekiel Emanuel, Brian D. Richards et al.
48 citations
In a nonrandomized controlled trial, psilocybin was administered to groups of patients with cancer who also had major depressive disorder, using a one-to-one therapist-to-patient ratio. The aim was to develop a scalable, rapidly effective depression treatment. The trial suggests that this approach may offer a feasible model for delivering psilocybin therapy to larger numbers of patients while maintaining therapeutic support.
Frontiers in Psychiatry
December 6, 2023
Elliot Marseille, Manish Agrawal, Paul Thambi et al.
40 citations
Group psychedelic-assisted therapy, compared with individual therapy, reduces clinician costs by 50.9% for MDMA treatment of PTSD and 34.7% for psilocybin treatment of major depressive disorder, saving $3,467 and $981 per patient respectively. Using 2023 data from two trial sites and published prevalence estimates, treating all eligible U.S. adults with PTSD or MDD over ten years with group therapy would require 6,711 fewer full-time clinicians for MDMA-PTSD and 1,159 fewer for psilocybin-MDD, saving up to $10.3 billion and $2.0 billion. Adopting group protocols could lower costs, ease clinician shortages, and expand patient access.
Cancer
December 18, 2023
Yvan Beaussant, Kabir Nigam, Zachary Sager et al.
22 citations
Patients with cancer and depression who received psilocybin-assisted therapy in a group setting found the approach generally acceptable. The group sessions increased their sense of safety and preparedness, fostered connection and belonging, and deepened the meaning of their experience, opening dimensions of self-transcendence and compassion. Key factors influencing acceptability included the therapeutic framework, the complementary role of individual sessions, and group size and structure. The findings suggest that combining group and individual sessions may enhance perceived safety and efficacy compared to either format alone, offering a scalable model for integrating psilocybin-assisted therapy into cancer care.
Journal of Psychopharmacology
August 29, 2025
Niall M. Mcgowan, James Rucker, Rachel Yehuda et al.
10 citations
A single 25 mg dose of psilocybin, given with psychological support, was safe and well-tolerated in 22 adults with PTSD. No serious adverse events occurred, and most side effects (headache, nausea, crying, fatigue) resolved within a day. PTSD symptoms, measured by the CAPS-5 scale, showed a clinically meaningful average decrease of nearly 30 points at 4 and 12 weeks after the dose, and this improvement was linked to the intensity of the psychedelic experience. Functional impairment and quality of life also improved. The open-label design and small sample size mean further controlled trials are needed to confirm efficacy.
Psychedelic medicine (New Rochelle, N.Y.)
March 1, 2025
Rebecca Ehrenkranz, Manish Agrawal, Sandeep M Nayak et al.
7 citations
Public discourse about psychedelic treatments has shifted from past fearmongering to current effusive optimism, but the field would benefit from more balanced attention to both risks and benefits. While most adverse events related to psychedelics are mild, some have been severe and serious, and public education about those risks is necessary. As more studies are conducted and eligibility criteria are relaxed to improve access, the incidence and severity of adverse events are predicted to increase. No medical intervention is risk-free, so quantifying and effectively communicating the risk/benefit profile of psychedelics will become increasingly important.
Journal of Palliative Medicine
August 17, 2023
Robert Gramling, Emily Bennett, Keith Curtis et al.
6 citations
Directly observing therapeutic connection during psilocybin-assisted therapy is feasible. In a clinical trial, three coders independently reviewed audio and video from four 8-hour psilocybin administration sessions, identifying 372 moments of therapeutic connection. Eighty-three percent of these moments were detected by at least two coders, and 41% by all three. Coders used both audible cues (speech prosody, words) and visible cues (body movements, eye gaze, touch) in 51% of observed events. The expressions of connection varied as the drug's effects on consciousness changed over time. The findings suggest that evaluating both sound and video is necessary to capture the full range of therapeutic connection.
International Review of Psychiatry
May 23, 2024
Rebecca Ehrenkranz, Manish Agrawal, J. Kim Penberthy et al.
5 citations
Prolonged Grief Disorder (PGD) affects up to 10% of bereaved people, causing functional impairment and intense yearning for at least a year after loss. Current treatments are mainly psychological, and more options are needed. Psychedelics like psilocybin and MDMA may help because they reduce depression and PTSD symptoms in clinical trials and produce subjective effects relevant to existential distress in PGD. No randomized clinical trials have yet tested psychedelics for PGD, but initial survey and open-label studies suggest a consistent trend toward grief reduction. A randomized clinical trial is the appropriate next step to explore this potential.
Cancer
June 15, 2025
Manish Agrawal, Kim Roddy, Betsy Jenkins et al.
4 citations
A single 25 mg dose of psilocybin combined with psychotherapy provided long-term relief from depression and anxiety in patients with cancer. Two years after treatment, over half of the 28 patients showed significant reduction in depression, with an average 15-point drop on the Montgomery Asberg Depression Rating Scale, and half maintained that improvement. Nearly half also experienced significant anxiety reduction, averaging a 13.9-point decrease on the Hamilton Anxiety Rating Scale, with 43% sustaining the benefit. The findings indicate a potentially paradigm-changing alternative to standard antidepressants for this population.
General hospital psychiatry
January 1, 2025
Yvan Beaussant, Elise Tarbi, Kabir Nigam et al.
3 citations
Psilocybin-assisted therapy (PAT) is promising for cancer-related depression, but little is known about how the therapeutic context affects patient experiences. In interviews with 28 patients with cancer and depression who participated in a clinical trial, participants described the psilocybin experience as intense and demanding. Therapeutic benefits were closely tied to their ability to "surrender"—accepting and remaining open to the experience's intensity and unpredictability. A safe, supportive, and ethical environment was critical for trust and engagement. Preparation and integration were key to maximizing benefit. Music played a variable role, sometimes enhancing and other times distracting. The clinical setting provided safety, while ceremonial elements added meaning.
Journal of Clinical Oncology
June 1, 2022
Manish Agrawal, Paul Thambi, Sarah Shnayder
3 citations
A single 25 mg dose of psilocybin, given in a group setting within a cancer center, produced a large and sustained reduction in depression symptoms in cancer patients with major depressive disorder. Over eight weeks, depression scores on the MADRS scale dropped by an average of 19.1 points, 24 of 30 patients achieved a sustained response (at least 50% reduction), and half showed complete remission one week after treatment, maintained through eight weeks. No serious adverse events occurred, and all 30 patients completed the trial. The results suggest that psilocybin therapy is safe, feasible, and effective for this population, and that group treatment may improve scalability.
EClinicalMedicine
December 1, 2025
Nadav Liam Modlin, Victoria Williamson, Guy M Goodwin et al.
2 citations
Psilocybin treatment for post-traumatic stress disorder, when delivered with standardized preparation and support, may allow patients to engage with trauma-related material indirectly through affective, somatic, and self-transcendent experiences, such as feelings of unity or dissolution of self, rather than requiring direct confrontation with traumatic memories as in standard therapies. This qualitative study, nested within a phase 2 trial involving 21 adults with PTSD, identified four core themes: non-pharmacological factors for psychological safety and trust, the experiential nature of psilocybin treatment, engagement with trauma-related material, and comparative reflections on prior therapies. The findings suggest psilocybin offers a meaningful therapeutic opportunity, but larger controlled studies are needed.
Journal of Clinical Oncology
June 1, 2023
Manish Agrawal, Sarah Shnayder, Heather Honstein et al.
2 citations
A single dose of psilocybin combined with group and individual psychological support led to long-term relief from depression in cancer patients with major depressive disorder. At 18 months, 64.2% of patients showed a clinical response (at least 50% reduction in depression scores) and 57.1% achieved full remission. Depression and anxiety severity scores continued to decrease from baseline to 8 weeks and through 18 months. The findings suggest psilocybin-assisted therapy may be an effective treatment for depression in people with cancer.
Psychedelic Medicine
October 8, 2025
Elise C. Tarbi, Skye A. Miner, Kabir Nigam et al.
1 citation
Patients with cancer and depression describe their cancer experience as deepening their awareness of mortality and prompting them to reprioritize relationships and efforts. In a trial of psilocybin-assisted group therapy, participants sought not only relief from depression but also a new perspective on existential worries and spiritual resources. After treatment, they reported lasting effects including an enhanced sense of meaning, agency, aliveness, and connectedness, describing the experience as a healing, unfolding transformation. The findings illuminate how psilocybin-assisted therapy may address existential suffering and foster personal growth in this population.
Healthcare (Basel, Switzerland)
June 5, 2026
Elise C Tarbi, Ian Bhatia, Nabil Balach et al.
A direct observation coding system can reliably identify moments when people narrate experiences of awe during psychedelic-assisted therapy. In 32 video-recorded therapy sessions from a Phase 2 trial of psilocybin-assisted therapy for advanced cancer, two coders independently identified 246 moments of awe narration across 16,760 minutes. Coders were substantially more confident when vastness was present (odds ratio 4.3). The coding system was refined to split accommodation into two components: initial cognitive disruption and later engagement with that disruption. Awe narration is observable using explicit definitional criteria, providing a foundation for larger-scale studies.
Psychedelic medicine (New Rochelle, N.Y.)
June 1, 2026
William E Rosa, Stephanie Napolitano, Natalie Mcandrew et al.
Meaning-centered psychotherapy (MCP) is a manualized, brief intervention that enhances meaning and purpose and appears to be a natural therapeutic partner for psilocybin-assisted therapy (PAT) in patients with cancer and major depressive disorder. In a phase 2 open-label trial, seven patients (ages 53-80) and six therapists (with 9-44 years of experience) participated in surveys and focus groups to adapt MCP for psilocybin. Focus groups highlighted the value of psilocybin experiences, group support, and MCP both separately and together. A 5-session model called MCP-PSIL was developed. The group format was emphasized, though individual MCP may be appropriate in some cases.
Psychodynamic psychiatry
June 1, 2026
Nadav Liam Modlin, Zsofia Elek, Carolina Maggio et al.
Psychedelic therapy may help people access unconscious mental content—preverbal, dissociated, or developmentally buried material—that emerges through bodily sensations, symbolic images, and intense emotions. A psychodynamic framework, drawing on psychoanalytic theory, can guide clinicians in working with this material across four phases: screening, preparation, the treatment session, and follow-up integration. Although neurobiological mechanisms like 5-HT2A receptor activation are well studied, unconscious processes remain underexplored. The authors argue that psychoanalytic models, though currently underrepresented, can deepen understanding of therapeutic change beyond symptom reduction and should inform future research, training, and individualized care as psychedelic treatments move toward broader clinical use.