Journal of Pain and Symptom Management
September 1, 2023
Benjamin R. Lewis, Eric L Garland, Kevin Byrne et al.
60 citations
Psilocybin-assisted group therapy appears safe and feasible for treating depression in cancer patients. In an open-label pilot trial, twelve participants with a depressive disorder received one high-dose (25 mg) psilocybin session within a three-week group program. Depression scores on the HAM-D scale decreased substantially from an average of 21.5 at baseline to 10.09 at two weeks and 14.83 at six months. Six of twelve participants met remission criteria (HAM-D below 7) at two weeks, and no serious adverse events occurred. The group format may reduce therapist time while maintaining possible efficacy, warranting further study.
Journal of psychopharmacology (Oxford, England)
January 1, 2023
Brent M Kious, Zach Schwartz, Benjamin R. Lewis
44 citations
Personal use of psychedelics by researchers may threaten objectivity and ethical conduct in psychedelic science. The paper explores whether such use can make investigators overly enthusiastic about psychedelics, potentially biasing study design, results reporting, and treatment of participants. Critiques of the MAPS MDMA-Assisted Therapy trials for PTSD have raised similar concerns. The authors elaborate on these risks and discuss practical strategies to reduce perceived conflicts of interest, aiming to inform policy for psychedelic research and clinical use.
Journal of Psychedelic Studies
January 18, 2023
Benjamin R. Lewis, Kevin Byrne, John Hendrick et al.
22 citations
Psilocybin-assisted psychotherapy is usually given one-on-one, but group formats might offer unique benefits and help scale treatment. The HOPE trial tested psilocybin-enhanced group therapy in cancer patients with depression. Three cohorts of 4–6 participants each received three group preparatory sessions, one high-dose (25 mg) group psilocybin session, and three group integration sessions. This report presents qualitative survey data from participants and therapist observations, offering guidelines for protocol design, screening, space, therapist team structure, group process, music, and timeline. Primary clinical outcomes are still being analyzed.
Focus
July 1, 2023
Benjamin R. Lewis, Kevin Byrne
9 citations
MDMA-assisted psychotherapy shows promise as a treatment for posttraumatic stress disorder (PTSD), a chronic and disabling condition. Existing evidence-based therapies have significant limitations. The U.S. Food and Drug Administration granted MDMA "breakthrough therapy" status in 2017 after preliminary Phase II results. Phase III trials are underway, with anticipated FDA approval in late 2023. This review covers the evidence base, pharmacology, proposed causal mechanisms, risks, limitations, and future directions for this treatment.
EClinicalMedicine
September 24, 2025
Megan Hosein, Matthew J Reid, Sarah A. Walser et al.
5 citations
Psilocybin and other psychedelics show promise as a new class of psychiatric treatments, but their rapid development risks outpacing the guidelines and infrastructure needed for safe clinical integration. A consensus statement from the US National Network of Depression Centers (NNDC) Task Group on Psychedelics and Related Compounds, comprising psychiatrists, psychologists, neuroscientists, psychedelic researchers, and healthcare consultants, recognizes psilocybin's therapeutic potential while emphasizing the need for further research. Key gaps include understanding therapeutic dosage, efficacy across diverse populations, and long-term safety. The authors call for diversified funding, collaborative research, standardized provider training, and careful ethical consideration. They advocate for a balanced approach prioritizing rigorous science and equitable access, noting the single-country focus limits international generalizability.
PLoS Medicine
September 19, 2025
Benjamin R. Lewis, John Hendrick, Kevin Byrne et al.
5 citations
Adding a single 25 mg dose of psilocybin to an 8-week Mindfulness-Based Stress Reduction (MBSR) program led to a significantly larger reduction in depressive symptoms among frontline healthcare workers than MBSR alone, with no serious adverse events. In a small randomized trial of 25 physicians and nurses with depression and burnout related to the COVID-19 pandemic, the combination group showed a 4.6-point greater drop on the Quick Inventory of Depressive Symptoms at two weeks post-intervention. This advantage diminished by six months. Secondary measures of burnout, demoralization, and connectedness also favored the psilocybin group but did not survive statistical correction. Larger trials are needed to confirm durability and generalizability.
medRxiv
January 1, 2025
Benjamin R. Lewis, John Hendrick, Kevin Byrne et al.
3 citations
preprint
Adding a single 25 mg dose of psilocybin to an 8-week mindfulness-based stress reduction (MBSR) program reduced depression and burnout symptoms more than MBSR alone in frontline physicians and nurses who worked during the COVID-19 pandemic. In a randomized trial with 25 participants, those receiving psilocybin-assisted therapy plus MBSR showed larger decreases in depressive symptoms at two weeks and six months, and greater improvements in burnout, demoralization, and connectedness. No serious adverse events occurred; only mild to moderate side effects were reported. The findings suggest that combining psilocybin with mindfulness training may be a promising treatment for depression and burnout in healthcare workers.
Journal of Anesthesiology and Pain Therapy
October 3, 2022
Benjamin R. Lewis, Kevin Byrne, Anna C. Beck
1 citation
No Summary
Journal of Psychedelic Studies
September 15, 2021
Benjamin R. Lewis, Kevin Byrne
1 citation
Major depressive disorder (MDD) is a poor target for early psychedelic research aiming at FDA approval, according to this critique of a recent Phase II trial comparing psilocybin-assisted therapy with escitalopram. The psychiatric category of MDD is heterogeneous, vaguely defined, and overdiagnosed, making it difficult to detect a reliable signal with any intervention, especially in non-severe cases. Current rating scales like QIDS and HAM-D fail to capture functional status, quality of life, and well-being—outcomes more relevant to psychedelic interventions. Additionally, psychedelic experiences often foster acceptance or equanimity toward suffering, which may be orthogonal to symptom reduction as measured by these scales. The authors argue for alternative research directions.
Journal of psychopharmacology (Oxford, England)
February 5, 2026
Benjamin R. Lewis, Matthew J Reid, Andrew M Novick et al.
Clinical trials of classical psychedelics like psilocybin for mental health conditions face unique challenges that may persist if these treatments enter clinical practice. Four categories of challenges with trial participants are identified: treatment nonresponse, expectancy effects and functional unblinding, post-session psychological difficulties, and contagion effects. Management strategies for study teams to mitigate these risks are described. The National Network of Depression Centers and similar organizations can guide best practices to responsibly advance this promising field.