MAPS’ Drug Development Strategy: MDMA-Assisted Psychotherapy for PTSD
This talk will describe MAPS' overall clinical development strategy for navigating the regulatory requirements for developing MDMA-assisted psychotherapy into an FDA-approved prescription treatment for people suffering from PTSD. We will review the steps and milestones associated with the three-year timeline for Phase 2 and the FDA End-of-Phase 2 meeting, and the additional five-year timeline for Phase 3. The presentation will outline new FDA programs that may be helpful in expediting the process, including Fast Track, Special Protocol Assessment, Breakthrough Drug Designation, and Expanded Access. This general strategy also applies to other psychedelic drug development programs.
An Analysis of the Working Alliance in MDMA-Assisted Therapy
One component of the therapeutic relationship formed between client and therapist is the working alliance. This alliance is an agreement on the goals of treatment, agreement about how to reach those goals within treatment, and the bond that forms from a trust and confidence that the tasks will bring the client closer to his or her goals. One operant mechanism in MDMA-assisted psychotherapy may be an increased ease in developing such an alliance. The current study in Boulder, Colorado uses the Segmented Working Alliance Inventory Observer-Based Measure (S-WAI-O) to track changes in the alliance both within and over the course of treatment sessions. The S-WAI-O was used to assess whether changes in working alliance were associated with the MDMA-assisted psychotherapy. Findings will be discussed.
Ingmar Gorman, MA, has researched substance use and misuse since 2006. As an undergraduate at the New College of Florida, he completed a 40-year follow-up study on the perspective of mental health experts who worked with hallucinogens in the former Czechoslovakia. One year after presenting his research at the Psychedelic Forum in Switzerland, Ingmar Gorman interned at the Prague Psychiatric Center as an Assistant Research Scientist. Now a doctoral student in Clinical Psychology at the New School for Social Research, he is currently investigating the therapeutic alliance in the context of MDMA-assisted psychotherapy. Ingmar Gorman is also establishing an alcohol abuse prevention program at the New School Counseling Center and serves as Research Study Assistant at the Sloan-Kettering Institute.
Pharmacokinetics and Phenomenology of Inhaled Salvinorin A in Humans
Matthew Johnson, PhD
Authors: Matthew W. Johnson, Katherine A. MacLean, Chad J. Reissig, Michael J. Caspers, Thomas E. Prisinzano, Roland R. Griffiths
Salvia divinorum is a plant with a long history of sacramental use among indigenous people of Oaxaca, Mexico. Salvinorin A, a kappa opioid agonist, has been identified as the principal psychoactive constituent of Salvia divinorum. Although traditional use of Salvia divinorum involves oral consumption of a tea, recent non-traditional use typically involves inhalation by smoking/vaporizing. In this completed study, the pharmacokinetics and subjective effects of inhaled salvinorin A were examined in six psychologically and physically healthy hallucinogen-using adults. Plasma samples were analyzed in triplicate via liquid chromatography-tandem mass spectrometry using a +5 mass analogue of salvinorin A as internal standard. Repeated measures regression showed salvinorin A levels were significantly (p < .01) associated with participant and monitor ratings of drug strength and monitor ratings of unresponsiveness, distance from usual daily reality and psychological distress. This is the first study to demonstrate a direct relationship between changes in plasma levels of salvinorin A and behavioral/subjective effects in humans. Results confirm the efficacy of a vaporization/inhalation technique for studying the effects of salvinorin A across multiple doses and across time.
Matthew W. Johnson, PhD is Assistant Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine. Dr. Johnson is an expert in addiction and the behavioral and psychological effects of psychoactive drugs in humans. He has published human drug administration research with cocaine, nicotine, caffeine, various sedatives, and hallucinogens including psilocybin, dextromethorphan, and salvinorin A. In 2008, he published recommended safety guidelines for the re-emerging field of human hallucinogen administration research, and in 2011 the first placebo-controlled study of the psychoactive effects of salvinorin A in humans. In published research with psilocybin he has examined mystical-type effects, persisting changes in attitudes and behaviors, personality change, and psilocybin effects on headache. He is currently studying the effects of psilocybin on a meditation program, and psilocybin in the treatment of anxiety and depression among cancer patients. Dr. Johnson is also principal investigator of an ongoing pilot study examining the putative anti-addiction efficacy of psilocybin in the context of tobacco smoking cessation.
Jose Carlos Bouso, PhD
This talk will present data from research where the subjective effects of 2C-B were studied. Subjects answered a survey in which they were asked about desirable and undesirable physical and psychological effects on the short, middle, and long term after 2C-B use. They also completed psychometric rating scales (RHS and VESSPA) scoring subjective effects of 2C-B and data were compared with data obtained after the administration of MDMA, Salvia divinorum, ayahuasca, and d-amphetamine in previous studies of our group. Potential clinical uses of 2C-B will also be discussed.
José Carlos Bouso’s is conducting research to collect preliminary data on the safety and efficacy of varying doses of MDMA administered in a psychotherapeutic setting to women with chronic post-traumatic stress disorder (PTSD) as a result of a sexual assault. He also has been conducting neuropsychological research into the long-term effects of drugs such as cocaine and cannabis. He has done transcultural research, extensively studying the long-term effects of ayahuasca use in different cultures and ecosystems, both in Spanish and in Brazilian communities. José Carlos Bouso is co-author of several scientific papers and book chapters. He currently combines his activity as a clinical researcher at the IMIM (Institut Hospital del Mar d'Investigacions Mèdiques) with his work as Scientific Projects Manager at the International Center for Ethnobotanical Education, Research, and Service (ICEERS; iceers.org).
James Fadiman, PhD
James will describe how to best use psychoactive materials for enhanced problem solving, a poorly understood and under-researched area. However, there are established methods that open minds to useful solutions for real problems. He will share his personal experience as part of a group that established the basic guidelines: set and setting, substance and dosage, as well as whatever else was necessary to effectively dissolve barriers to solving hard science problems. Drawing from that research, he will describe which aspects of enhanced cognitive processes lead to successful solutions, followed by reviewing the range of problems attempted, solutions found, and the implications for renewed research. Even informal experimentation can be vastly improved by understanding how best to use these materials to potentiate new thinking about technical obstacles and to initiate conceptual breakthroughs.
James Fadiman, PhD completed his dissertation at Stanford on the effectiveness of LSD-assisted therapy just as all research was shut down. During the subsequent 40-year lull, he has held a variety of teaching, consulting, training, counseling, and editorial positions. He has taught in psychology departments and design engineering, and for the past three decades at the Institute of Transpersonal Psychology (now Sofia University) that he co-founded. He has published textbooks, professional books, a self-help book, a novel, and a series of videos ("Drugs: The Children are Choosing") for National Public Television. His books have been published in eight languages. He was featured in a National Geographic documentary and had three solo shows of his nature photography. He sits on two non-profit boards and has been the president of several small natural resource companies. He was involved in researching psychedelics for spiritual, therapeutic, and creative uses when it was legal, and recently published The Psychedelic Explorer's Guide: Safe, Therapeutic, and Sacred Journeys and released a series of videos (with Kokyo Henkel) on Buddhism and Psychedelics. He is now conducting surveys of psychedelic use and has pioneered research on micro-dosing of a number of substances for a host of conditions (jamesfadiman.com).
From the Johns Hopkins Psilocybin Findings to the Reconstruction of Religion
Walter Houston Clark has defined “religion” as an individual's inner experience of a Beyond, especially as evidenced by active attempts to harmonize his or her life with that Beyond. The Johns Hopkins experiments suggest that a large fraction of mentally healthy people with spiritual interests can have a profound experience of a Beyond—a mystical-type experience—with the aid of several hours' preparation and a supervised psilocybin session. Furthermore, most of the study volunteers report that encounter as among the most spiritually significant of their lives and as bringing sustained benefits. How do we get from such experiences (however occasioned) to “religion” in Clark’s sense, and in the sense of a group pursuing spiritual ends? Perhaps that transition is, as Brother David Steindl-Rast claims, inevitable. The talk will address that process, and will argue that some social organizations have strong but unacknowledged religious aspects. It will also ask how nascent religious groups can form in ways that minimize the pathologies that so often have given the “r-word” a bad name, while channeling sociality to cultivate individual and collective well-being.
Robert Jesse is Convenor of the Council on Spiritual Practices (CSP; csp.org). CSP's interest in non-ordinary states focuses on the betterment of well people, in contrast to the medical-model treatment of patients with psychiatric diagnoses. Through CSP, Bob was instrumental in forming the psilocybin research team at Johns Hopkins University, and he has co-authored three of its scientific papers. He also lead the writing of an amicus brief for the U.S. Supreme Court in support of the União do Vegetal's use of a sacramental tea containing DMT, a controlled substance. A unanimous Court upheld the UDV’s right to its practice. Bob has long participated in the development of the Bay Area spiritual community that draws liberally from the non-creedal, non-hierarchical ways of the Quakers (the Religious Society of Friends). His formal training is in electrical engineering and computer science.
Clinical Perspectives in Preparing and Managing High Dose Psilocybin Sessions: Insights from Johns Hopkins
Brian D. Richards, PsyD and Mary P. Cosimano, MSW
This presentation will focus on difficulties occasionally encountered during conduct of the Johns Hopkins psilocybin studies in healthy volunteers and in psychologically distressed cancer patients. Procedures will be discussed which ensure adequate volunteer screening, preparation, management, and aftercare for high dose psilocybin sessions. We will also discuss our experience as primary guides in the psilocybin studies including techniques we have found helpful in supporting volunteers during challenging states of consciousness occasioned by high dose psilocybin. Case descriptions of some of these difficult sessions and follow-up will be presented.
Brian D Richards, PsyD is a Licensed Clinical Psychologist and Clinical Director and Education Center Coordinator for MedOptions, the largest regional provider of behavioral health services in southern New England and the Mid-Atlantic. Dr. Richards is also Faculty/Affiliated Investigator at the Johns Hopkins University School of Medicine, where he works on States of Consciousness Research at the Behavioral Pharmacology Research Unit, Bayview Medical Campus. He specializes in acute outpatient care, diagnostic psychological testing, long-term care/rehabilitation, drug and alcohol abuse, death and dying, spirituality in end of life care, mindfulness and brain-science-based approaches to personal growth and healing, and therapeutic lifestyle changes.
Mary Cosimano, MSW, is currently with the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine and has served as study guide and research coordinator for the psilocybin studies for over a decade. During that time she has served as a session guide for the psilocybin studies and has conducted over 200 sessions. She has worked as a clinician teaching individual and group meditation to breast cancer patients in research at Johns Hopkins, as a behavior modification counselor for weight loss, and has 15 years of experience with direct patient care as a hospice volunteer. Ms. Cosimano has been extensively involved in all five psilocybin studies, as well as Salvia divinorum and dextromethorphan studies conducted at Johns Hopkins. She will provide her perspective as primary guide and study coordinator in the Johns Hopkins Psilocybin Studies.
Katherine MacLean, PhD
An increasingly large body of scientific evidence indicates that various types of mental training can improve cognitive performance, psychological well-being and brain function. In particular, meditation techniques drawn from the Buddhist tradition have proven effective for cultivating a calm mind, open heart and healthy body. The re-packaging of ancient Buddhist practices into a suite of modern therapeutic tools is one of the great success stories of so-called complementary and alternative medicine. What, then, can Buddhist meditation teach us about psychedelic science? While evidence is accumulating that psychedelic compounds can promote long-term improvements in behaviors, attitudes and well-being, there remain obstacles to the acceptance of psychedelics as modern medicine. In this talk, I will review and compare data from previous longitudinal studies of meditation and psilocybin, present preliminary findings from ongoing research examining the effects of psilocybin in long-term meditation practitioners, and discuss future directions for the use psychedelics and meditation to promote optimal health and well-being.
Katherine MacLean, PhD, is an Instructor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine, where she conducts research on psilocybin and meditation. As a graduate student at the University of California, Davis, Katherine was supported by a National Science Foundation research fellowship to study changes in behavior and brain function during three months of intensive meditation training. After obtaining her PhD in psychology in 2009, she joined the Behavioral Pharmacology Research Unit at Johns Hopkins as a postdoctoral research fellow. Since 2009, Katherine has trained with Roland Griffiths, Matthew Johnson, Bill Richards, and Mary Cosimano on studies of psilocybin and other hallucinogens (Salvia divinorum) and has guided nearly 40 psilocybin sessions. She is currently investigating the intersection between psilocybin and meditation, including potential brain mechanisms and therapeutic applications. Outside of research, Katherine practices daily meditation, occasional handstands, and perpetual astonishment.
William Richards, PhD
Reflecting on his past involvement in clinical research with psychedelic substances at the University of Göttingen and the Maryland Psychiatric Research Center, and in the current investigations at the Johns Hopkins School of Medicine, Dr. Richards will discuss the discrete alternative states of consciousness that appear to facilitate psychotherapeutic progress, and the factors of set, setting, and dosage that increase the probability of their occurrence. Attention will be paid to both the art and the science of psychedelic psychotherapy with appreciation for the phenomenology of psychedelic experiences, and for techniques of integrating new insights in normative states of consciousness.
William A. Richards, PhD, is a psychologist in the Psychiatry Department of the Johns Hopkins University School of Medicine, Bayview Medical Center, currently pursuing research with entheogens, and also a clinician in private practice in Baltimore. His graduate degrees include MDiv from Yale Divinity School, STM from Andover-Newton Theological School and a PhD from Catholic University, as well as studies with Abraham Maslow at Brandeis University and Hanscarl Leuner at Georg-August University in Göttingen, Germany, where his involvement with psilocybin research originated in 1963. From 1967 to 1977, he pursued psychotherapy research with LSD, DPT, MDA, and psilocybin at the Maryland Psychiatric Research Center, including protocols designed to investigate the promise of entheogens in the treatment of alcoholism, severe personality disorders, narcotic addiction, the psychological distress associated with terminal cancer, and also their use in the training of religious and mental health professionals. From 1977-1981, he was a member of the psychology faculty of Antioch University in Maryland. His publications began in 1966 with “Implications of LSD and Experimental Mysticism,” coauthored with Walter Pahnke, and published in the Journal of Religion and Health.
Continuing Education (CE) credit is available for psychologists, social workers, MFTs, and nurses. More information is available at the Spiritual Competency Resource Center.