Psychedelic therapy panel at the Interdisciplinary Conference on Psychedelics Research 2016. With Alicia Danforth, Rick Doblin,  Marcela Ot’Alora, Bill Richards, Friederike Meckel Fisher and Jeff Guss.

This talk will focus on the regulatory challenges involved in developing psychedelic-assisted psychotherapy through the FDA/EMA process. Issues to be discussed will be the initial reasons behind the strategy of working through the FDA/EMA process, the rationale for why MAPS is prioritizing MDMA as the psychedelic and PTSD as the clinical condition to move first into Phase 3 trials, standardizing the therapeutic method with treatment manual and adherence criteria, how we approached the double-blind issue, the importance of an outcome measure that is administered by Independent Raters and the procedure we’ll use to minimize bias, how we reached out to the Department of Defense and Department of Veterans Affairs National Center for PTSD, the issue of the FDA’s Risk Evaluation and Mitigation System (REMS) to regulate MDMA-assisted psychotherapy post-approval, and the FDA’s data exclusivity program and MAPS’ sustainability plan through our MAPS Public Benefit Corporation.

Existential distress in reaction to a life-threatening illness is often undertreated and mistreated in western medicine.  A randomized clinical trial of psilocybin assisted therapy for treatment of existential distress in cancer patients was recently completed at NYU School of Medicine with Stephen Ross, MD, Principal Investigator and Drs. Anthony Bossis, PhD and Dr. Guss as Co-Principal Investigators.   The results will be published as “Rapid and Sustained Symptom Reduction following Psilocybin Treatment for Anxiety and Depression in Patients with Life-Threatening Cancer:  A Randomized Controlled Trial” during 2016. During talk, Dr. Guss will describe the NYU study in detail, including its history, the structure and content of the therapy sessions and our method for training clinicians to work as study therapists.   After presenting outcome data from the study, a short film with participants from the study will be shown.
Biography
Jeffrey Guss, MD is a psychiatrist, psychoanalyst, and researcher with a specializations in psychoanalytic therapy and the treatment of substance used disorders. He is a Co-Principal Investigator, study therapist and the Director of Therapist Training for the NYU School of Medicine’s study on psilocybin-assisted psychotherapy in the treatment of existential distress related to cancer diagnosis and treatment, and is a co-author of “Rapid and Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety and Depression in Patients with Life-Threatening Cancer: A Randomized Clinical Trial”. He is also a study therapist for NYU School of Medicine’s “Psilocybin Treatment of Alcohol Dependence” RCT study.
Dr Guss is particularly interested in the integration of psychedelic therapies with contemporary models of psychodynamic therapy and exploration of the practice models for future use of psychedelic medicines in clinical practice. He is an Instructor, Mentor and on the Council of Advisors for the California Institute of Integral Studies’ Center for Psychedelic Therapies and Research and on the Advisory Board for the Center for Optimal Living’s Psychedelic Education and Continuing Care Program. He has published on the topics of gender and sexuality in Studies in Gender and Sexuality and Psychoanalysis, Culture and Society. Dr. Guss maintains a private practice of psychiatry and psychotherapy in New York City.

This lecture provides a rough overview of four decades of research into psychedelics in Europe and the US.
Research “started again” in the mid-eighties, when European and American researchers penetrated through administrative barriers. Early MDMA psychotherapy research began in the end-1970s, modern German studies into mescaline and MDEA began in the late 1980s. Since 1985 the founding of the Swiss Physicans Society for Psycholytic therapy (SAEPT) and the European College for the Study of Consciousness (ECSC) by Leuner, Albert Hofmann and others triggered these developments. The founding of the Multidisciplinary Association for Psychedelic Studies (MAPS) in 1986 and the  Heffter Research Institute (HRI) in 1993 and later marked the stabilization of developments. A lot of research studies was initiated since the beginning 1990s, especially in respect to MDMA. MDE and psilocybin.
Since 2010 the scientific climate changed, partially because of ineffective antidepressants and malign side-effects of psychopharmacological medications. Another track came from the realization of the complexitiy of brain function. Substances which were formerly called “dirty drugs” for being not specific to one receptor (system) became interesting again because they may configurate a matrix of brain-functioning helpful for healing. Psychotherapy-promoting drugs like some psychedelics may become relevant therapeutic options in the future.
A retrospective view suggests a wave-like pattern of interest in psychedelics. Appropriate recognition of the limits of using these substances in everyday psychiatric/psychotherapeutic practice is discussed.
Biography
Torsten Passie (*1961) is currently Visiting Professor at Harvard Medical School (Boston, USA). He studied philosophy, sociology (M.A.) at Leibniz-University, Hannover and medicine at Hannover Medical School. His medical dissertation was on existential psychiatry. He worked at the Psychiatric University Clinic in Zürich (Switzerland) and with Professor Hanscarl Leuner (Göttingen), the leading European authority on hallucinogenic drugs. His extensive research at Hannover Medical School covers the psychophysiology of altered states of consciousness and their healing potential, including clinical research with hallucinogenic drugs (cannabis, ketamin, nitrous oxide, MDMA, psilocybin). He is an internationally known expert on altered states of consciousness and the pharmacology of hallucinogenic drugs. His publications appeared in Journal of Psychopharmacology, Neuropsychobiology, Addiction, CNS Neuroscience and Therapeutics, Journal of Nervous and Mental Disease and others.