Promising early-phase clinical research with classic or serotonergic psychedelics (e.g. 5HT2a agonists) was conducted from the late 1950s through the mid-1970s in the US and Europe on over 40,000 research participants, mostly with LSD and to a much lesser degree psilocybin, yielding over a thousand scientific papers. However, following the initial promise and then hype associated with psychedelic therapy, and in reaction to public health concerns about an increase in recreational use and associated harmful effects (i.e. psychosis, reckless behavior), the US began to restrict the use of psilocybin, LSD, and all serotonergic psychedelics by the general public starting in the mid-1960s. Further backlash occurred against psychedelics from organized psychiatry and government culminating in the enactment of the federal Controlled Substance Act in 1970 that classified all serotonergic psychedelics in the most restrictive category as DEA schedule I drugs, defined as high addictive liability and no known medical utility. Due to stigma and legal restrictions, federal funding ended for clinical research with psychedelics. Following this, clinical researchers working in this area had to abandon their programs of research. The research was halted before any definitive conclusions could be reached concerning the safety and clinical efficacy of psychedelic therapy for any psychiatric disorder. However, clinical research conducted in that era, in addition to establishing a favorable safety profile, suggested therapeutic signals of psychedelic-assisted psychotherapy with the most robust data in treating alcohol use disorder, followed by psychiatric and existential distress (and pain) associated with end-of-life cancer
Stephen Ross, MD, Chairperson, Presenter
Dr. Stephen Ross is Professor of Psychiatry and Child & Adolescent Psychiatry at the NYU Grossman School of Medicine. Dr. Ross is a founding member of the NYU Psychedelic Research Group and is currently Associate Director of the NYU Langone Health (NYULH) Center for Psychedelic Medicine and Director of the NYULH Psychedelic Medicine Research Training Program. In 24 years at NYU and Bellevue, Dr Ross has been involved in a variety of leadership roles in administration, teaching and research. He previously served as Director of the Division of Alcoholism and Drug Abuse in the Psychiatry Department at Bellevue Hospital Center for 12 years, Director of Addiction Psychiatry at NYULH/Tisch Hospital, Director of the NYU Addiction Psychiatry Fellowship, Director of the Bellevue Inpatient Dual Diagnosis Training Unit, and Director of the Bellevue Opioid Overdose Prevention Program. Dr Ross’s main research interests focus on developing novel pharmacologic-psychosocial approaches to treating: addictive disorders, including the intersection between pain and addiction; psychiatric and existential distress associated with advanced or terminal cancer; major depression; PTSD; and personality disorders. Dr Ross is principal investigator or co-principal investigator on several ongoing and completed psychedelic-focused studies at NYULH including: phase II RCT of psilocybin-assisted psychotherapy in patients with life-threatening cancer-related psychiatric and existential distress, phase I/II RCT of LSD-assisted psychotherapy in advanced cancer pain syndromes, phase II RCT of psilocybin-assisted psychotherapy in alcohol use disorder, phase I/II controlled trial administering psilocybin to religious professionals, and phase II RCT of psilocybin treatment for Major Depressive Disorder. Dr Ross also acts as a co-investigator and study therapist for phase II/III trials of MDMA-assisted psychotherapy for PTSD, and is an expert in cannabinoid therapeutics and PI of a NIDA funded study of CBD administration in patients with chronic radicular pain on chronic opioid therapy.
Bertha Madras, PhD, Presenter
Bertha Madras is a Professor of Psychobiology at Harvard Medical School (at Harvard nearly 38 years), based at McLean Hospital and cross-appointed at Massachusetts General Hospital.
Scientific Research. Her research has focused on neurobiology, pharmacology, brain imaging, drug discovery for addiction, neuropsychiatric disorders, and drug policy. With collaborators, her lab discovered: (1) methods for detecting Parkinson’s disease in living brain; (2) molecular targets in brain of cocaine, ecstasy (MDMA), modafinil, THC (of marijuana), CBD; (3) different responses of psychoactive drugs in adolescents/adults; (4) new candidate therapeutics; (5) THC toxicity, others.
Authorship. She is author of more than 200 scientific manuscripts, articles, book chapters and co-editor of books: “The Cell Biology of Addiction”; “Effects of Drug Abuse on the Human Nervous System”; “Imaging of the Human Brain in Health and Disease”.
Inventor. She is a recipient of 19 U.S. and 27 international issued patents with collaborators.
Government Service.
• Deputy Director for Demand Reduction in the White House Office of National Drug Control Policy (ONDCP), Executive Office of the President, a presidential appointment confirmed with unanimous consent (99-0) by U.S. Senate
• In a 2015 landmark Federal Court case, served as sole expert witness for U.S. Department of Justice in a case to either maintain marijuana in Schedule I or to de-schedule the substance.
• Opioid Use Disorder. (2017) She was appointed as one of six members of the President’s Commission on Combating Drug Addiction and the Opioid Crisis along with Governors C. Baker (MA); C. Christie, (Chair, NJ); R. Cooper (NC), Congressman P. Kennedy (RI); Attorney General P. Bondi (FL). Dr. Madras was charged by Governor Christie with shepherding and writing major components of the final Commission Report.
• International. Authored a World Health Organization commissioned report, “Update of Cannabis and its Medical Use” (2015) and co-authored “The Health and Social Effects of Nonmedical Cannabis Use
• Vatican Pontifical Academy of Sciences, Panelist on Narcotics, and co-authored final report
• Member, Committee on drugs, National Football League (NFL)
• Member (current) of the National Academy of Medicine Collaborative on the Opioid Crisis
Educational Service.
• Developed international course on the Cell Biology of Addiction at Cold Spring Harbor Laboratories
• Directed production of a museum exhibit, a CD (licensed by Disney) ©“Changing Your Mind: Drugs in the Brain” and play, with the Museum of Science, Boston
Honors, awards.
• Recipient of research and public service awards, including a NIDA Public Service Award, CPDD Innovator Award, Jack H. Mendelson Memorial Research Award, Adler Distinguished Service Award, CADCA National Leadership Award, Nils Bejerot Award, others
• The 2006 Better World Report designated her brain imaging invention as “one of 25 technology transfer innovations (university to industry) that changed the world”.
Her experiences in neuroscience research, drug addiction, education, government and public service offer a unique perspective at the intersection of science and public policy.
Jack Henningfield, MD, Presenter
Jack Henningfield’s education and experience are in the behavioral and pharmacological sciences specializing in neuropharmacology, addiction, and the development of new medicines for substance use disorders and a broad range of other central nervous system disorders. After graduating from the University of Minnesota with a major in psychology (BA summa cum laude) in 1974, Jack was accepted into the Psychopharmacology Training Program at the University of Minnesota with a United States Public Health Service Fellowship. Jack received a Ph.D. in experimental psychology with a psychopharmacology supporting program in 1977, and he continued his research on animal models of alcohol use disorder with a National Council on Alcoholism postdoctoral fellowship. In 1978, Jack was offered a faculty position in the Behavioral Pharmacology Research Unit of the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine where he remained until present. In 1980, Jack joined the Intramural Research Program (Addiction Research Center) of the National Institute on Drug Abuse (NIDA) where he was tenured as pharmacologist and served as Chief of the Clinical Pharmacology Branch as well as the Biology of Dependence and Abuse Potential Assessment Section, and worked with FDA and DEA on Controlled Substances Act and other regulatory frameworks. Jack left NIDA in 1996 to join Pinney Associates to focus more on medicinal development, FDA drug regulation, and public health. Jack’s publications include more than 500 peer-reviewed articles, books, book chapters, special journal issues, and contributions to reports by the U.S. Surgeon General, Institute of Medicine, Royal Society of Medicine, and World Health Organization. Many of these published works address addiction, abuse liability assessment, opioids, tobacco, and other potentially addictive substances. Over the past decade his work has included development of psychedelic-based medicines, cannabinoids, and dietary supplements, and regulatory frameworks to minimize unintended consequences. A common theme throughout all of Jack’s work is service to public health by evidence-based interventions and regulatory policies to ensure equitable access to all people who could benefit.