OPEN Foundation

Day: 21 July 2016

Rick Doblin – Regulatory challenges involved in developing psychedelic-assisted psychotherapy through the FDA/EMA process

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.

Neurovascular Plasticity of the Hippocampus One Week after a Single Dose of Ketamine in Genetic Rat Model of Depression


Glutamatergic system and the structural plasticity hypothesis are principal components for rapid and sustained antidepressant effects of novel antidepressant therapeutics. This study represents the first investigation of the structural plasticity of the hippocampus as one of the main contributed mechanisms to the sustained anti-depressive effect of ketamine. Flinders Sensitive Line (FSL) and Flinders Resistant Line (FRL) rats were given a single intraperitoneal injection of ketamine (15 mg/kg) or saline 7 days before perfusion-fixed. The optical fractionator method was used to estimate the total number of neurons in the granular cell layer. Microvessel length in the molecular layer of DG was evaluated with global spatial sampling method. By use of the physical disector method, the number of synapses was estimated. The volume of the hippocampus was larger in the FRL-vehicle rats compared with FSL-vehicle group and in FSL-ketamine versus FSL-vehicle rats (P < 0.05). The number of non-perforated synapses was significantly higher in the FSL-ketamine versus FSL-vehicle group, (P = 0.01). A significant effect of ketamine on enhancement of the number of neurons in DG in FSL rats was observed (P = 0.01). The total length of the microvessels 1 week after ketamine treatment in the FSL rats significantly increased (P  < 0.05). Our results indicate that neurovascular changes of hippocampus could be one of the possible mechanisms underlying the sustained antidepressant effect of ketamine by reversing alteration of the number of the excitatory synapses, neuronal number and length of the microvessels in the hippocampus.

Ardalan, M., Wegener, G., Polsinelli, B., Madsen, T. M., & Nyengaard, J. R. (2016). Neurovascular Plasticity of the Hippocampus One Week after a Single Dose of Ketamine in Genetic Rat Model of Depression. Hippocampus.
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Long-term follow up of psilocybin-assisted smoking cessation


Background: A recent open-label pilot study (N = 15) found that two to three moderate to high doses (20 and 30 mg/70 kg) of the serotonin 2A receptor agonist, psilocybin, in combination with cognitive behavioral therapy (CBT) for smoking cessation, resulted in substantially higher 6-month smoking abstinence rates than are typically observed with other medications or CBT alone. Objectives: To assess long-term effects of a psilocybin-facilitated smoking cessation program at ≥12 months after psilocybin administration.
Methods: The present report describes biologically verified smoking abstinence outcomes of the previous pilot study at ≥12 months, and related data on subjective effects of psilocybin.
Results: All 15 participants completed a 12-month follow-up, and 12 (80%) returned for a long-term (≥16 months) follow-up, with a mean interval of 30 months (range = 16–57 months) between target-quit date (i.e., first psilocybin session) and long-term follow-up. At 12-month follow-up, 10 participants (67%) were confirmed as smoking abstinent. At long-term follow-up, nine participants (60%) were confirmed as smoking abstinent. At 12-month follow-up 13 participants (86.7%) rated their psilocybin experiences among the five most personally meaningful and spiritually significant experiences of their lives.
Conclusion: These results suggest that in the context of a structured treatment program, psilocybin holds considerable promise in promoting long-term smoking abstinence. The present study adds to recent and historical evidence suggesting high success rates when using classic psychedelics in the treatment of addiction. Further research investigating psilocybin-facilitated treatment of substance use disorders is warranted.

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Jeff Guss – Psilocybin-assisted therapy for treatment of existential distress in cancer patients

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.
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.

Torsten Passie – Waves of research with psychedelics 1980-2015: an overview

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.
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.

21 March - Ketamine Discussion with Celia Morgan, Filip Tylš & Will Barone