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Sandeep M Nayak

Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

16 papers in the library · 833 citations · publishing 2021-2026

Papers

Single-Dose Psilocybin Treatment for Major Depressive Disorder

JAMA August 31, 2023 Charles L Raison, Gerard Sanacora, Joshua Woolley et al. 493 citations

A single 25-mg dose of synthetic psilocybin, administered with psychological support, produced a clinically significant and sustained reduction in depressive symptoms and functional disability over 43 days in adults with major depressive disorder. In a phase 2 trial of 104 participants, those receiving psilocybin showed a mean 12.3-point greater improvement on the Montgomery-Asberg Depression Rating Scale at day 43 compared with those receiving a niacin placebo. Psilocybin also improved daily functioning and led to more sustained response, though not remission. No serious adverse events occurred, but psilocybin was associated with more overall and severe adverse events.

Belief changes associated with psychedelic use.

Journal of psychopharmacology (Oxford, England) January 1, 2023 Sandeep M Nayak, Manvir Singh, David B Yaden et al. 87 citations

A survey of 2374 people who reported a belief-changing psychedelic experience found that a single experience increased non-physicalist beliefs, including dualism, paranormal/spirituality, and consciousness in both mammals and non-mammals, with medium to large effects. Beliefs in superstition changed negligibly. The percentage identifying as a believer in a higher power or ultimate reality rose from 29% before to 59% after the experience. Greater mystical experiences during the psychedelic session were linked to larger belief shifts. These changes persisted an average of 8.4 years later.

Classic Psychedelic Coadministration with Lithium, but Not Lamotrigine, is Associated with Seizures: An Analysis of Online Psychedelic Experience Reports

Pharmacopsychiatry August 4, 2021 Sandeep M Nayak, Natalie Gukasyan, Frederick S Barrett et al. 67 citations

Combining classic psychedelics like LSD or psilocybin with the mood stabilizer lithium carries a high risk of seizures. In an analysis of 62 online reports of such combinations, 47% involved seizures and 18% resulted in bad trips; 39% required medical attention. In contrast, none of 34 reports combining psychedelics with the mood stabilizer lamotrigine involved seizures, and most lamotrigine reports (65%) indicated no effect on the psychedelic experience. The findings suggest that lithium, but not lamotrigine, may pose a significant seizure danger when taken with psychedelics, though further research is needed.

Reconsidering "dissociation" as a predictor of antidepressant efficacy for esketamine.

Psychopharmacology April 1, 2023 David S Mathai, Sandeep M Nayak, David B Yaden et al. 36 citations

For esketamine, a form of ketamine used for treatment-resistant depression, there is no clinically meaningful link between how dissociated a person feels during the drug experience and how much their depression improves. Analyzing data from 576 participants across two clinical trials, researchers measured dissociation with the Clinician-Administered Dissociative States Scale (CADSS) and depression with the Montgomery-Åsberg Depression Rating Scale (MADRS). A statistical model found no significant interaction between dissociation and antidepressant effect over four weeks. A separate analysis showed that each additional point on the dissociation scale on day 1 was associated with a very small 0.

The Potential of Psychedelics for End of Life and Palliative Care.

Current topics in behavioral neurosciences January 1, 2022 David B Yaden, Sandeep M Nayak, Natalie Gukasyan et al. 31 citations

End-of-life and palliative care have improved, but psychopharmacological options for depression, existential distress, and well-being remain limited. This review examines recent clinical research on psychedelics for patients with life-threatening diagnoses and proposes that psychedelics could offer clinicians an additional treatment option in end-of-life and palliative care settings.

The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement

American Journal of Bioethics May 2, 2024 Edward Jacobs, B. Earp, Paul S. Appelbaum et al. 29 citations

A workshop on psychedelic ethics, the first Hopkins-Oxford Psychedelic Ethics (HOPE) meeting, was held in August 2023 at the University of Oxford to address ethical issues surrounding psychedelics. The organizers (BDE, DBY, EJ) aimed to foster interdisciplinary discussion on topics such as informed consent, therapeutic use, and societal implications. The report outlines the workshop's structure, key themes, and proposed guidelines for ethical research and practice in the field.

Practical considerations in the establishment of psychedelic research programs.

Psychopharmacology January 1, 2025 Brian S Barnett, M Frances Vest, Marcus S Delatte et al. 20 citations

Establishing psychedelic research programs at academic medical centers in the United States faces unique obstacles because psychedelics are intensely psychoactive, carry sociopolitical baggage, and most are Schedule I drugs. This article reviews academic literature and draws on the authors' experiences with regulatory agencies and conducting basic science, investigator-initiated, and industry-sponsored psychedelic trials. It recommends that investigators cultivate broad institutional support early and anticipate challenges in securing funding, obtaining FDA Investigational New Drug approval, sourcing clinical-grade drug, getting DEA Schedule I researcher registration and any required state license, preparing treatment and storage spaces, managing controlled substance inventory, and engaging the local community. With planning, persistence, and expert assistance, these hurdles are likely surmountable.

Perceived Risk of Trying Lysergic Acid Diethylamide in the United States from 2015 to 2019: Are Americans Assessing Lysergic Acid Diethylamide's Risk Profile More Favorably?

Psychedelic medicine (New Rochelle, N.Y.) June 1, 2024 Brian S Barnett, Akhil Anand, Elizabeth N Dewey et al. 20 citations

From 2015 to 2019, the proportion of Americans who perceived 'great' risk in trying LSD fell from 70.5% to 64.8%, a statistically significant linear decline. Lower perceived risk was associated with later survey year, personal LSD use, younger age, higher education, male gender, identifying as a sexual minority, and past-year psychological distress. Higher perceived risk was linked to identifying as Black or Hispanic, past-year suicide attempt, and having children at home. Among respondents under 18, Hispanic identity showed no association, and male gender was linked to higher perceived risk. Most Americans still perceive great risk in trying LSD.

Psychedelic Experiences Increase Mind Perception but do not Change Atheist-Believer Status: A Prospective Longitudinal Study

Journal of Psychoactive Drugs May 7, 2024 Sandeep M Nayak, Sydney H White, Samantha N Hilbert et al. 18 citations

A prospective longitudinal study of 657 people planning a psilocybin experience outside a laboratory found that after the experience, participants reported increased perception of minds in various living and non-living entities such as plants and rocks, replicating earlier findings. However, the study found little to no change in participants' metaphysical beliefs, such as dualism, or in their self-reported Atheist-Believer status. These results contrast with cross-sectional studies suggesting psilocybin experiences alter Atheist-Believer status and non-naturalistic beliefs, but they support the relevance of mind perception and mentalization processes.

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

Classic psychedelics carry both greater acute challenging effects and persisting negative effects compared to cannabis, but also produce greater positive acute and persisting effects. In two studies using quota-based sampling to approximate US Census demographics, participants reported on their first or most memorable experiences with either substance. Predictors of psychedelic outcomes—such as dose level, presence of others, religiosity, and personality—explained only a small degree of the variation. The findings offer a more nuanced characterization of the risks and benefits of psychedelic experiences relative to cannabis.

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

Practitioners of psychedelic therapy largely view physical touch as an important component of treatment, but they also emphasize strict professional boundaries and the necessity of patient consent. In a survey of 40 practitioners who had overseen an average of 41.4 psychedelic sessions, 70% agreed that therapeutic touch is crucial. However, most deemed specific forms of touch inappropriate: 63% considered bodywork inappropriate, and 98% considered full-body contact inappropriate. Free-response analysis showed 96% supported touching the patient's hand and 58% supported touching the shoulder. Unprompted, 63% of respondents stressed the importance of consent. These views may inform future practice.

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

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.

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

Practitioners who oversee psychedelic therapy sessions slightly prefer an 'emotive' approach—one that emphasizes human and spiritual elements—over a 'neuromodulatory' approach that focuses on biological drug effects. A survey of 40 qualified respondents from at least 4 countries, 11 U.S. states, and 16 institutions found no consensus on many psychological support strategies. Four key themes emerged: the importance of trust, the role of spirituality, creating an emotional setting, and conceptualizing negative experiences. Practitioners trained at the Multidisciplinary Association for Psychedelic Studies or the California Institute of Integral Studies showed a significantly stronger emotive preference than those trained elsewhere.

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

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

Blocking the 5-HT1A receptor with pindolol before giving a low dose of DMT to experienced hallucinogen users intensified the drug's subjective effects, with a moderate effect size. Blood pressure also increased shortly after DMT administration, while heart rate was unchanged. The findings suggest that 5-HT1A receptor activity normally dampens the subjective effects of psychedelics, pointing to a functional role for this receptor in shaping the psychedelic experience.

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

Journal of psychopharmacology (Oxford, England) January 1, 2026 Jack E Henningfield, Frederick S Barrett, Suzette M Evans et al.

Roland R. Griffiths was a highly influential scientist in behavioral and neuropsychopharmacology, known for his rigorous research on abuse liability of substances including alcohol, benzodiazepines, caffeine, tobacco, and psychedelics. This review, authored by his former mentees and collaborators, describes his methodical approach to research, his inclusive and collegial mentoring style, and his role in advancing scientific methods for abuse liability assessment, policy, and regulation. His work culminated in the establishment of the Johns Hopkins Center for Psychedelic and Consciousness Research, reflecting his curiosity-driven, humanity-serving science that continues to inspire innovation.

Provider perspectives on challenges in treatment during psychedelic therapy.

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

Providers administering psychedelic drugs in clinical trials report a range of challenges, including intense dysphoria during sessions (42% of respondents), disappointment with the intervention (25%), and re-engaging with traumatic experiences (17%). An anonymous survey of 40 qualified respondents who oversaw 1656 psychedelic sessions identified 11 distinct themes of challenges. 70% of respondents felt that individuals with PTSD or prior trauma need additional psychological support, and they recommended an average of 9.8 hours of total psychological support for first-time recipients with serious mental illness. These findings highlight the need to incorporate potential adverse experiences into psychological support protocols for clinical trials and future guidelines.