OPEN Foundation

OPEN Lectures

Marcela Ot’alora – Using MDMA for trauma integration

Sponsored by the Multidisciplinary Association for Psychedelic studies (MAPS), this Phase II clinical pilot study explores the safety and efficacy of administering MDMA in conjunction with Psychotherapy to participants with treatment resistant Posttraumatic Stress Disorder (PTSD). Evidence in completed phase II trials, and preliminary findings in this phase II trial show promising results in reducing PTSD symptoms with a good safety profile.  Given the limited effectiveness of current available medications and therapeutic strategies, MDMA-assisted psychotherapy holds promise as a treatment option.  This talk will focus on methodology as well as individual participant experiences.
Biography
Marcela Ot’alora G. was born and raised in Colombia, S.A. and now lives in Boulder, Colorado, USA. She has a MA in Transpersonal Psychology and a MFA in Fine Arts. Marcela is dedicated to the treatment and research of trauma, first through art and later through the use of MDMA-assisted Psychotherapy. She worked as a co-therapist in the first government approved MDMA-assisted psychotherapy study in Madrid Spain and is the Principal Investigator of the Phase II MDMA-assisted psychotherapy study in Boulder, Colorado.

Alicia Danforth – Exploring MDMA-assisted therapy as a new pathway to social adaptability for autistic adults

The first randomized, double-blinded, placebo-controlled Phase 2 study of MDMA-assisted therapy for the treatment of social anxiety in autistic adults is nearing completion. Fear and avoidance behaviors associated with social anxiety interfere with the ability to work, attend school, and develop relationships. The search for psychotherapeutic options for autistic adults who want to improve social adaptability is imperative considering the lack of effective conventional treatment options for this population in which social anxiety is common. This talk will feature an overview of the research as well as preliminary findings.
Biography
Alicia Danforth, PhD is a clinical psychologist and co-investigator for a current phase 2 randomized, double-blinded, placebo-controlled pilot study on the effects of MDMA-assisted therapy on social anxiety in autistic adults. Her dissertation research was on the subjective MDMA/ecstasy experiences of adults on the autism spectrum. She began her work in clinical research with psychedelic medicines with Charles Grob, MD at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center in 2004. She co-facilitated sessions for the first clinical trial of psilocybin treatment for existential anxiety related to advanced cancer since psilocybin became a controlled substance in the United States. She also co-developed and taught the first graduate-level course on psychedelic theory, research, and clinical considerations for therapists and researchers at the Institute of Transpersonal Psychology.

Roland Griffiths – Overview of the Johns Hopkins psilocybin research project

This presentation will summarize past and ongoing studies from the Johns Hopkins Psilocybin Research Project, which started about 15 years ago. Laboratory research includes administering psilocybin to healthy volunteers, psychologically distressed cancer patients, cigarette smokers seeking abstinence, ordained clergy, and beginning and long-term meditators. The results from several studies suggest that mystical-type experiences appear to mediate sustained positive changes in attitudes, moods, and behavior. Individuals responding to recruitment for a “bad trip” survey on the internet affirmed concerns about psilocybin ingestion in uncontrolled circumstances potentially leading to acute psychological distress, risky behavior, or enduring psychological symptoms. However, when psilocybin is given in laboratory studies to screened, prepared, and supported participants the incidence of risky behavior or enduring psychological distress is extremely low.
Biography
Roland R. Griffiths, Ph.D., is professor in the Departments of Psychiatry and Neurosciences at the Johns Hopkins University School of Medicine. His principal research focus in both clinical and preclinical laboratories has been on the behavioral and subjective effects of mood-altering drugs. His research has been largely supported by grants from the National Institute on Health and he is author of over 300 journal articles and book chapters. He has been a consultant to the National Institutes of Health, and to numerous pharmaceutical companies in the development of new psychotropic drugs. He is also currently a member of the Expert Advisory Panel on Drug Dependence for the World Health Organization. He has an interest in meditation and is the lead investigator of the psilocybin research initiative at Johns Hopkins, which includes studies of psilocybin occasioned mystical experience in healthy volunteers and cancer patients, and a pilot study of psilocybin-facilitated smoking cessation.

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.

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.
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.

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.
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.

Robin Carhart-Harris – Brain imaging and depression research with psychedelics

Brain imaging and depression research with psychedelics
The talk will review brain imaging work on the action of psychedelics on the brain and describe the results of a clinical trial assessing psilocybin as a treatment for depression. It will also review the broader societal impact of psychedelic drug-use and discuss its implications.
Biography
Robin Carhart-Harris studies the brain effects of LSD, psilocybin (magic mushrooms), and MDMA. Most recently he has completed the first phase of a clinical trial looking at the potential of psilocybin to treat depression.

Second part of special issue compiled by OPEN published

cdarcoverAt the end of last month we published the first part of a special issue on the beneficial effects of psychedelics in the treatment of addiction of the scientific journal CDAR. Now, the second part has been published with three more articles on this subject.

In the first article, Robin Mackenzie argues that too little attention is paid to how psychedelics might positively influence both one’s life and one’s death. It is her contention that too often, neuroscientific research focuses on remedying diseases or disorders. Instead, she argues for cognitive liberty and posits that neuroscience should illuminate the role psychedelics might play in improving well-being and ‘human flourishing’.

A review by Mitch Liester traces the turbulent history of LSD, from its initial use as a ‘psychotomimetic’ (a substance that mimics psychosis-like states of consciousness) to its employment as a pharmacological aid in helping ‘addicted’ patients and its widespread association with counterculture movements in the 1960s. Liester provides an overview of its pharmacology, neurobiology and a detailed phenomenology of its subjective effects. The author argues that it is time for an unbiased reexamination of LSD’s potential as a pharmacological adjunct in addiction treatment.

Recently, studies at Johns Hopkins University have drawn attention to the significance of transcendental or mystical aspects of the psychedelic experience. These studies suggest a pivotal role for mystical-type experiences in promoting wellbeing, leading to measurable positive changes in the behaviour, attitudes, and values of healthy participants. The rigorous research study conducted by Albert Garcia-Romeu and colleagues at the same university provides further insight in how psilocybin-occasioned mystical experiences translate to the context of heavy tobacco dependence. Their clinical pilot study shows abstinence rates after psilocybin treatment that are significantly higher than that of conventional treatments for tobacco dependence, which motivates an important discussion on the future of addiction treatment.

The articles are open access and can be found here.

We are very proud to be in the position to share these articles with you and would like to extend our gratitude to all the writers and peer reviewers that have helped us in putting this special issue together.

Article Overview
Editorial (Thematic Issue: Introduction to ‘Beneficial Effects of Psychedelics with a Special Focus on Addictions’)
What Can Neuroscience Tell Us About the Potential of Psychedelics in Healthcare? How the Neurophenomenology of Psychedelics Research Could Help us to Flourish Throughout Our Lives, as Well as to Enhance Our Dying
A Review of Lysergic Acid Diethylamide (LSD) in the Treatment of Addictions: Historical Perspectives and Future Prospects
Psilocybin-Occasioned Mystical Experiences in the Treatment of Tobacco Addiction

Special issue compiled by OPEN published in scientific journal

cdarcoverThe OPEN Foundation is proud to announce that we compiled two special issues of the journal CDAR (Current Drug Abuse Reviews). The title of the Special Issues is ‘Beneficial Effects of Psychedelics with a Special Focus on Addictions’.

The idea of this special issue originated at the Interdisciplinary Conference on Psychedelic Research, organised by the OPEN Foundation in 2012. This special issue of CDAR takes an interdisciplinary approach to the topic of psychedelics and mental health, while maintaining a particular focus on applications of psychedelics in the fields of substance abuse and addiction. This special issue also takes a critical look at some widespread assumptions about psychedelics, introduces new ideas and suggests novel directions for future research.

For instance, in the first article, Beatriz Labate and Kenneth Tupper take a critical approach towards the instruments of modern science. They reflect upon the Amazonian brew ayahuasca, which is rapidly gaining popularity, both from individuals interested in experiencing its effects as well as from scientists studying this plant admixture. Drawing from the ever-expanding and interdisciplinary field of ayahuasca studies, Tupper and Labate question the possibility of absolute objectivity when studying ayahuasca and other psychedelics. They also look at how psychedelics are generally regarded and how these conceptualizations influence current research and the scientists pursuing their investigations.

How should one respond to individuals undergoing a difficult experience after ingesting a psychedelic substance? Is it possible to transform such a negative experience into a beneficial one? These questions are at the heart of Maria Carvalho and colleagues’ article. The authors provide a detailed account of how an integrated service that offers ‘compassionate care’ to music festival participants may be effective in mitigating the negative effects occasioned by the use of psychedelics, taken in an unfamiliar and highly stimulating environment. Their article shows how an intervention that combines principles from harm reduction, risk reduction and crisis intervention can effectively deal with the unintended negative consequences of recreational (psychedelic) drug use. This increases knowledge on the risks and benefits of altered states of consciousness – not just those induced by psychedelic substances – for both the individual and professional caregivers.

In the first wave of scientific interest in psychedelics in the 1950s and 1960s, their effects on ‘alcoholism’ represented one of the early approaches. Michael Winkelman’s article reviews the historical evidence on the safety and efficacy of various psychedelics used as aids in the treatment of substance dependence disorders. The author also provides an overview of the various possible mechanisms of action that underlie the effectiveness of these therapies. Given the safety of psychedelics and the limited success of current conventional treatments in treating addiction, Winkelman argues that medical professionals have a moral duty to further pursue the investigation of treatment with psychedelics.

As the field of neurosciences makes its advances, more researchers look towards the potential offered by psychedelics in understanding the brain mechanisms underlying their idiosyncratic effects. Samuel Turton’s article provides unique insights in the subjective experiences of study participants. He describes the phenomenology of the experiences of fifteen participants in an fMRI-scanner after intravenous psilocybin administration.

Brazilian neuroscientist Rafael Guimarães dos Santos contributes to this special issue with a thorough review on how the extremely potent, but little investigated non-classical psychedelic Salvinorin A might be effective as a pharmacological agent in treating psychostimulant substance addiction. In his article, he reviews the available data on κ-opioid receptor agonists and their mechanisms of action in animal studies, presenting a novel perspective on the potential effectiveness of this psychedelic substance in the treatment of addiction to psychostimulants such as amphetamine and cocaine.

The next part of the special issue will feature articles by Mitch Liester, Robin MacKenzie and Albert Garcia-Romeu, Roland Griffiths and Matthew Johnson.

The articles are open access and can be found here.

Article overview

Editorial (Thematic Issue: Introduction to ‘Beneficial Effects of Psychedelics with a Special Focus on Addictions’)

Ayahuasca, Psychedelic Studies and Health Sciences: The Politics of Knowledge and Inquiry into an Amazonian Plant Brew

Crisis Intervention Related to the Use of Psychoactive Substances in Recreational Settings – Evaluating the Kosmicare Project at Boom Festival

Psychedelics as Medicines for Substance Abuse Rehabilitation: Evaluating Treatments with LSD, Peyote, Ibogaine and Ayahuasca

A Qualitative Report on the Subjective Experience of Intravenous Psilocybin Administered in an fMRI Environment

Salvinorin A and Related Compounds as Therapeutic Drugs for Psychostimulant-Related Disorders