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Sandeep M. Nayak

Johns Hopkins University, Johns Hopkins Medicine

56 papers in the library · 1,823 citations · publishing 2021-2026

Papers

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Psilocybin-induced neurocardiogenic syncope: a case report.

Psychopharmacology May 28, 2026 Mazen A Atiq, Eli Weisman, Rodrigo B Guerra et al.

Psilocybin is among the serotonergic psychedelics closest to potential FDA approval, with growing evidence of therapeutic benefit across psychiatric conditions. As clinical trials expand, systematic characterization of adverse events (AEs) remains essential. While transient hypertensive responses are well documented, hypotensive events such as neurocardiogenic syncope (NCS) are rarely reported....

5-HT1A receptor blockade potentiates the subjective effects of DMT.

Journal of psychopharmacology (Oxford, England) May 2, 2026 Zarmeen Zahid, Rick J. Strassman, Clifford Qualls et al.

Serotonergic psychedelics are being investigated in the treatment of various disorders and in the improvement of well-being. Evidence suggests that their subjective effects may play a role in long-term behavioral outcomes. The subjective effects are mediated by 5-HT2A receptor agonism, but the 5-HT1A receptor may also play a role in the subjective effects. This study elucidates the effects of...

A living systematic review, meta-analysis and open-data resource of randomized controlled trials of psilocybin treatment for symptoms of depression

Nature Mental Health May 1, 2026 S. Parker Singleton, Brooke L. Sevchik, Analiese Lahey et al. 2 citations

This study presents a living systematic review and open-data meta-analytic database from 15 randomized controlled trials examining the effects of psilocybin treatment on depressive symptoms. Existing evidence suggests that psilocybin treatment alleviates depressive symptoms. Depression is a major cause of disability worldwide, motivating interest in psilocybin as a potential treatment. Here we...

Acute Cardiovascular Effects of Psilocybin: A Pooled Analysis of 14 Studies with Safety Recommendations

medRxiv Preprint Server April 28, 2026 Sandeep M. Nayak, Nathan D. Sepeda, Matthew Nielsen Dick et al. preprint

Background Psilocybin has increasingly been studied as a therapeutic for psychiatric and neurologic conditions, yet comprehensive cardiovascular safety data are limited. Current trials often exclude individuals with blood pressure ≥140/90 mmHg, criteria established conservatively without robust empirical support.

Psilocybin use among Basotho healers and non-healers in southern Africa

April 23, 2026 Eli Stark-Elster, Mamosebetsi Sethathi, Breyten Van der Merwe et al.

Reliable documentation of the traditional use of serotonergic psychedelics has long been confined to the Americas. Prevailing narratives often overstate the global prevalence and uniformity of traditional psychedelic use, extrapolating from a limited set of well-documented cases. Here, we report evidence of psilocybin mushroom use among Basotho traditional healers and non-healers in Lesotho and...

A living systematic review, meta-analysis, and open data resource of trials of MDMA-assisted therapy for PTSD

medRxiv Preprint Server March 27, 2026 Brooke L. Sevchik, S. Parker Singleton, Analiese Lahey et al. preprint

3,4-methylenedioxymethamphetamine (MDMA) has emerged as a potential treatment for post-traumatic stress disorder (PTSD), generating considerable enthusiasm in the field. However, rapidly changing evidence in a fast-moving field can be challenging to integrate. Here, we present a living systematic review and open-data meta-analytic resource on MDMA treatment for PTSD. In this initial release,...

Psychedelic medicine: mechanisms, evidence, and translation to practice

BMJ February 23, 2026 Edward Jacobs, Zarmeen Zahid, Jared T. Hinkle et al. 5 citations

Over the past 15 years, psychedelic treatments have garnered substantial clinical interest, with psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) advancing to phase 3 trials for various psychiatric conditions. This state-of-the-art review examines the evidence for these treatments and their proposed mechanisms of action, and identifies key challenges in clinical translation. Psychedelic...

Trip sitting or just sitting? Session facilitators substantially influence psychedelic experiences in clinical trials but not in healthy ones

Psychiatry Research February 13, 2026 Sean P. Goldy, Nathan D. Sepeda, Samantha Hilbert et al. 1 citation

Psychedelics' characteristic acute subjective effects predict therapeutic benefits, such as decreases in depression and anxiety. Thus, optimizing treatment involves better understanding which factors shape subjective effects. Session facilitators, who support participants before, during, and after psychedelic administration sessions, form an important part of the setting of these experiences....

Roland R. Griffiths, psychopharmacology pioneer: Abuse liability, alcohol, nicotine, caffeine, benzodiazepines, and psychedelics.

Journal of psychopharmacology (Oxford, England) 2026 Jack E Henningfield, Frederick S. Barrett, Suzette M Evans et al.

This review provides an overview of Roland R. Griffiths' history of research, and his mentoring and collaborating approach to science that contributed to his impact in behavioral and neuropsychopharmacology and psychedelic medicines development. The approach was to summarize studies in his major domains of research, including preclinical and clinical abuse liability assessment science, alcohol,...

Psychological support can be distinguished from psychotherapy: Clarifications for future empirical work.

General Hospital Psychiatry 2026 Jonathan R Schettino, Katherine Cheung, Sandeep M. Nayak et al.

Classic psychedelic studies involve interpersonal interactions with participants before, during, and after the acute effects of psychedelics. In the field of psychedelic research, there is currently a debate about whether this interpersonal interaction is most accurately considered "psychological support," "psychotherapy," or something else. Proponents of the psychological support label...

Causal Inference in Studies with Functional Unmasking: Psychedelics and Beyond

medRxiv Preprint Server December 5, 2025 Gabriel Loewinger, Mats J. Stensrud, Sandeep M. Nayak et al. preprint

In clinical trials for mental health treatments, functional unmasking (unblinding) is a widespread challenge wherein participants become aware of their assigned treatment. Unmasking is especially concerning with psychedelics, due to the near unmistakable acute effects (the “trip”), resulting in uncertainty about whether outcomes following treatment reflect true therapeutic properties of the...

Provider perspectives on challenges in treatment during psychedelic therapy.

Psychopharmacology October 27, 2025 David A Bender, Sandeep M. Nayak, Joshua S. Siegel et al.

Psychedelic treatments are considered to involve unique treatment challenges relative to other psychiatric interventions, though these are typically not explored in detail within clinical trial reports. To determine the types of challenges that providers encounter while administering psychedelic drugs in research settings and to assess provider opinions on safeguards that may be pursued to...

Out of control: Blinding, dose response, and psychosocial controls in psychedelic trials

Journal of Psychopharmacology September 1, 2025 Sandeep M. Nayak, Zarmeen Zahid 5 citations

As psychedelic clinical trials expand in scale and influence, foundational challenges in trial design have come into sharper focus. In this commentary, we examine three interrelated issues: 1) the failure of blinding in psychedelic trials, 2) the potential of alternate controls including dose-response designs as an empirical workaround, and 3) the persistent ambiguity surrounding psychosocial...

Psilocybin treatment for symptoms of depression: a living systematic review, meta-analysis, and data resource

medRxiv August 16, 2025 S. Parker Singleton, Brooke L. Sevchik, Analiese Lahey et al. preprint

Abstract Importance Depression is a major cause of disability worldwide, motivating substantial interest in psilocybin as a potential treatment. Objective To conduct a systematic review and meta-analysis of psilocybin’s impact on depressive symptoms and provide a living open data resource. Data Sources PubMed, Embase, Scopus, Web of Science, and PsycINFO retrieved by a systematic search up to...

The Role of Touch in Psychedelic Therapy: Perspectives From a Survey of Practitioners in Research Settings.

American Journal of Psychotherapy May 6, 2025 David A Bender, Sandeep M. Nayak, Joshua S. Siegel et al. 7 citations

Psychedelic therapies are promising new treatment options in psychiatry. Including the use of physical touch as part of treatment is an area of debate. This study aimed to characterize the viewpoints of practitioners on the use of touch in psychedelic therapy. An anonymous survey was distributed via e-mail to the contacts listed on ClinicalTrials.gov for trials of psilocybin and lysergic acid...

Psychedelic risks and benefits: A cross-sectional survey study.

Journal of psychopharmacology (Oxford, England) May 1, 2025 Sean P. Goldy, Benjamin A Du, Julia S Rohde et al. 15 citations

As classic psychedelics' therapeutic potential is studied and their popularity continues to rise, it is important to establish their relative risks and benefits. Previous surveys have tended to use convenience sampling on social media, select participants who have had either extremely positive or negative effects, and have not compared the risk/benefit profile of psychedelics to other...

Adverse Events Should Not Be Surprising in Psychedelic Research.

Psychedelic medicine (New Rochelle, N.Y.) March 1, 2025 Rebecca Ehrenkranz, Manish Agrawal, Sandeep M. Nayak et al. 7 citations

Research has demonstrated both risks and benefits to using psychedelics as a therapeutic intervention for a variety of mental health conditions. In recent years, the public discourse around psychedelic treatments has been largely positive and focused on benefits more than risks. We believe the field would benefit from more balanced attention to the risks as well as benefits of psychedelics...

Shame, Guilt and Psychedelic Experience: Results from a Prospective, Longitudinal Survey of Real-World Psilocybin Use

Journal of Psychoactive Drugs February 7, 2025 Amy Lehrner, Heather Jackson, David S. Mathai et al. 11 citations

The classic psychedelic psilocybin has attracted special interest across clinical and non-clinical settings as a potential tool for mental health. Despite increasing attention to challenging psychedelic experiences, few studies have explored the relevance of shame-related processes with psychedelic use. This prospective, longitudinal study involved sequential, automated, web-based surveys that...

Psychological Support Approaches in Psychedelic Therapy: Results From a Survey of Psychedelic Practitioners.

The Journal of Clinical Psychiatry February 5, 2025 David A Bender, Sandeep M. Nayak, Joshua S. Siegel et al. 3 citations

Objective: To assess the viewpoints of psychedelic practitioners in research settings on approaches to psychological support for psychedelic treatments. Methods: An anonymous survey was distributed via email to contacts listed on ClinicalTrials.gov for clinical trials of psilocybin and LSD, personal contacts of authors, and through snowball sampling. The survey included Likert type, multiple...

Examining differences in the effects and contexts of naturalistic psilocybin use for White participants vs. Participants of Color: A longitudinal online survey study.

Journal of Affective Disorders February 1, 2025 Grant Jones, Matthew X. Lowe, Sandeep M. Nayak et al. 12 citations

Psilocybin (a psychoactive compound found in "magic mushrooms" or "shrooms") has been gaining increased attention in research and popular culture as a number of clinical and observational studies have demonstrated that it may have potential for improving mental wellbeing. Relatedly, there has been a substantial uptick in naturalistic (e.g., real-world, non-clinical) psilocybin use in the United...

A Field-Wide Review and Analysis of Study Materials Used in Psilocybin Trials: Assessment of Two Decades of Research

Psychedelic Medicine January 20, 2025 Marianna Graziosi, Gabrielle Agin-Liebes, Mary P Cosimano et al. 9 citations

Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for...

Practical considerations in the establishment of psychedelic research programs.

Psychopharmacology 2025 Brian S. Barnett, M Frances Vest, Marcus S Delatte et al. 20 citations

There is increasing interest in establishing psychedelic research programs at academic medical centers. However, psychedelics are intensely psychoactive, carry considerable sociopolitical baggage, and most are Schedule I drugs, creating significant potential impediments to implementation. There is little formal guidance for investigators on navigating the complex on-the-ground obstacles...

Knowledge, attitudes, and concerns about psilocybin and MDMA as novel therapies among U.S. healthcare professionals.

Scientific Reports November 14, 2024 Erin Wang, David S. Mathai, Natalie Gukasyan et al. 18 citations

Psychedelic-assisted therapy (PAT) with substances like psilocybin and MDMA has shown promise for conditions including depression and post-traumatic stress disorder. Psilocybin and MDMA may become approved medicines in the coming decade. This study assessed knowledge and attitudes regarding PAT among 879 U.S. healthcare professionals via anonymous online survey. Multivariable linear regression...

The Effect of Psychedelics on Individuals with a Personality Disorder: Results from two Prospective Cohort Studies

Research Square October 15, 2024 Alexandra R. Gordon, Brennan M. Carrithers, Broc A. Pagni et al. 3 citations

Abstract Background: Personality disorders (PDs) are characterized by impairments in psychological functioning for which pharmacologic treatments have demonstrated limited efficacy. Psychedelics may offer a possible PD treatment, given preliminary evidence for their potential long-term positive effects on psychological functioning. However, little is known about safety or potential therapeutic...

Belief change and agnostic frames in psychedelic research and clinical contexts

Philosophical Perspectives on Psychedelic Psychiatry September 13, 2024 David B. Yaden, Sandeep M. Nayak, Roland R. Griffiths 4 citations

Abstract The proportion of people who change their metaphysical beliefs after psychedelic experiences is not yet known with specificity. However, it appears that belief changes can occur in some cases, and evidence more precisely estimating the prevalence and magnitude of such belief changes is accruing. The evidence for metaphysical belief changes is reviewed and the potential psychological...