Session II: Considering Practical Aspects of Psychedelics Research
Speakers
Moderator: Benjamin C. Silverman, M.D.
Senior IRB Chair, Mass General Brigham, Director of Ethics, McLean Institute for Technology in Psychiatry, McLean Hospital, Instructor in Psychiatry and Faculty Member in the Center for Bioethics, Harvard Medical School
Benjamin Silverman, M.D. is the Senior IRB Chair at Mass General Brigham. He is additionally the Chair of the Mass General Brigham Embryonic Stem Cell Research Oversight (ESCRO) Committee, Director of Ethics for the Institute for Technology in Psychiatry at McLean Hospital, and at Harvard Medical School, serves as an Instructor in Psychiatry and Faculty Member in the Center for Bioethics. Dr. Silverman’s academic interests center on research ethics, in particular pertaining to research conducted with vulnerable populations. His recent work has focused on the use of supported decision-making to promote inclusion and equal access in clinical research. Dr. Silverman received his medical degree from the Johns Hopkins University School of Medicine, completed his psychiatry residency at the MGH McLean Adult Psychiatry Residency Training program, and completed sub-specialty fellowship training in addiction psychiatry through Mass General Brigham. He additionally completed fellowship training with the Center for Bioethics, Harvard Medical School.
What are the challenges in designing scientifically sound clinical trials for examining the effects of psychedelics?
The power of psychedelics as potential treatment for mental illnesses is associated with a strong subjective psychological component. This creates problems for clinical trial designs, including the gold standard of double-blind randomized clinical trials (RCTs), for the objective examination of the biological effects of an intervention. The speaker will review these challenges and explore what meaningful options may exist for acquiring reliable generalizable knowledge about their effects.
Rachel Yehuda, Ph.D.
Professor of Psychiatry and Neuroscience, Director, Center for Psychedelic Psychotherapy and Trauma Research at Icahn School of Medicine at Mount Sinai; Director of Mental Health at the James J. Peters Veterans Affairs Medical Center
Rachel Yehuda, Ph.D., is an Endowed Professor of Psychiatry and Neuroscience of Trauma. She is also Director of Mental Health at the James J. Peters Veterans Affairs Medical Center. Dr. Yehuda is a recognized leader in the field of traumatic stress studies, PTSD, and intergenerational trauma. In 2019, Dr. Yehuda was elected to the National Academy of Medicine for her seminal contributions to understanding the psychological and biological impact of traumatic stress. In 2020, Dr. Yehuda established and now directs the Center for Psychedelic Psychotherapy and Trauma Research.
What are the challenges with evaluating and minimizing the risks of research involving psychedelics?
Since there is a strong psychological component for the effects of psychedelics, evaluating the risks of psychedelics must go beyond an understanding of their physiological effects and damages to bodily functions. This session will examine the potential for psychedelics to cause strange, unique, and even long-lasting effects on the mind, the importance of set and setting, and the impact of the guided assistance provided by therapists.
Natalie Gukasyan, M.D.
Assistant Professor, Columbia University School of Medicine
Natalie Gukasyan, M.D. is an Assistant Professor of Psychiatry at Columbia University Medical Center. After receiving her M.D. from Tulane University School of Medicine Dr. Gukasyan completed her internship and residency in psychiatry at Johns Hopkins. She went on to complete a NIDA T32 fellowship in behavioral pharmacology under the mentorship of Dr. Roland Griffiths, focusing on safety and efficacy of psilocybin-assisted therapy for people with mood and eating disorders. Before joining the faculty at Columbia, Dr. Gukasyan served as Medical Director of the Johns Hopkins Center for Psychedelic and Consciousness Research, where her research also spanned other clinical aspects of psychedelics including placebo and psychotherapy effects in treatment, as well as medication interactions.
Exploitation or inclusion? Exploring the ethical obligation and the unique challenges with including black and brown populations in psychedelic research
For the findings of research to be appropriately generalizable to benefit the populations in need, there is an ethical obligation to include black and brown populations in mental health research involving psychedelics. This session will explore the obstacles (including research funding and availability of research personnel) with conducting such research with black and brown individuals, the challenges with gaining their trust in the research enterprise, and what researchers can do to promote respect for these populations through the informed consent process.
Darron Smith, Ph.D., PA-C, DFAAPA
Associate Program Director, Research and Scholarship at MEDEX;
Co-Director for the Center for Novel Therapeutics in Addiction Psychiatry
Darron Smith is an associate professor in the Department of Family Medicine at the University of Washington. He is also Co-Director at the Center for Novel Therapeutics in Addiction Psychiatry (NTAP). The center recently received a large grant from the state of Washington to study the safety and efficacy of psilocybin on first responders with PTSD and alcohol use disorder. He is a physician assistant and US Army veteran with over 25 years of healthcare experience in primary care and behavioral health. He is also MAPS-trained in MDMA-assisted therapy. Dr. Smith’s research and scholarship examine US-based systems of race-based discrimination found in all societal domains, including healthcare policy and delivery. Dr. Smith’s current research and practice intertwine the study of applied neuroscience, race-based trauma, and mental illness by looking at the impact of EEG biofeedback versus MDMA-assisted psychotherapy on brainwave activity in individuals with racial trauma (PTSD). Dr. Smith serves on the board of directors for the American Psychedelic Prescribers Association (APPA) and the Chacruna Institute. He also sits on the Governor’s psilocybin advisory task force.
Addressing the challenges with conducting psychedelics research involving criminal justice-involved populations
There is a high concentration of mental illness among those currently or formerly incarcerated. PTSD and other trauma are also highly prevalent in this population. However, many are incarcerated or were formerly incarcerated because of the War on Drugs. This session critically explores whether and how psychedelic therapies could be useful for criminal justice-involved populations. Given the unique considerations associated with psychedelic therapies, what are the practical issues with researching psychedelics in these groups? Can psychedelics be ethically administered to people who are incarcerated or experiencing other forms of state supervision?
Logan Neitzke-Spruill, Ph.D.
Postdoctoral Associate, Center for Medical Ethics and Health Policy, Baylor College of Medicine
Logan Neitzke-Spruill is a post-doctoral associate in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. He is a sociologist focused on exploring drug issues in the United States from psychedelic science to the overdose epidemic. His research specifically addresses topics including the construction of scientific and medical knowledge about drugs, bioethical issues associated with drugs, how social-psychological and cultural phenomena shape drug, disparities in drug overdose, as well as how the study of drugs can advance a more holistic understanding of the relationship between culture, cognition, and the brain. His dissertation, called “Psychedelic Biomedicalization: Mainstreaming a ‘Scientific Revolution’”, investigates the emergence of psychedelic science and examines how this movement has been shaped by processes of biomedicalization. His solo and co-authored work has appeared in Sociological Forum, Journal for Studies on Alcohol and Drugs, Journal of Humanistic Psychology, and Journal of Psychedelic Studies.