Seminars

Title: “National Institutes of Health Healing Experience of All Life Stressors (NIH-HEALS): A measure of psycho-social-spiritual healing and its use in psilocybin studies”

Description: While psychedelics have been shown to improve psycho-spiritual well-being, the underlying elements of this change are not well-characterized. The NIH-HEALS posits that psycho-social-spiritual change occurs through the factors of Connection, Reflection & Introspection, and Trust & Acceptance. This presentation will review the development of The NIH HEALS. There will be discussion of its use in a trial using psilocybin for patients with cancer and depression.

Title: A Primer for Culturally Attuned Psychedelic Research

Description: Psychedelic research with diverse populations is necessary for inclusiveness, representativeness, and generalizability. Cultural attunement may be key to facilitating equitable research. In this presentation, Terence reviews prevalent psychological and pragmatic barriers to diversity – as part of set and setting – in modern psychedelic research. He also proposes potential strategies for the culturally attuned recruitment, assessment, and retention of diverse participants.

Title: An overview of the current psychedelic business and investment landscape

Title: Psilocybin’s Role in Depression: Usona Phase 2 Study Analysis

Description: Drs. Kelmendi and Sanacora briefly reviewed the findings from previous studies exploring the potential antidepressant properties of psilocybin and reviewed in detail, the findings of the recently published randomized single dose trial comparing the antidepressant effects of Psilocybin and Niacin sponsored by the Usona Institute.

Title: Mind Over Molecules: Unraveling the Neurobiological Aspects of Placebo Effects and their Implications for Psychedelic Medicine

Description: Placebo effects pertain to the positive outcomes resulting from a placebo or a treatment, primarily influenced by the participant's belief, not the treatment's actual pharmacological properties. Factors such as expectancy, prior therapeutic experiences, witnessing benefits in others, contextual and treatment-related cues, and interactions between patients and healthcare professionals can trigger these responses. The mere act of taking a treatment can activate various neurobiological and physiological mechanisms, involving systems like opioids, serotonin, noradrenaline, endocannabinoids, oxytocin, arginine vasopressin, dopamine, and the modulation of cytokines. Phenotypes associated with placebo effects can help tailor treatments to the needs of each single patient and advance a more personalized and effective healthcare interventions.

Title: Microdosing: Fact or Fiction?

Description: Microdosing of psychedelic drugs remains an extremely popular practice in the general population, and users claim a wide range of beneficial effects. However, it has been difficult to verify these benefits in controlled studies. This presentation will review some of the findings from controlled studies with microdoses of LSD, and identify some of the methodological challenges.

Title: Psychedelic Therapy for Depression - Clinical and Neuromechanistic Data

Title: Exploring mechanisms of psilocybin-assisted treatment for alcohol use disorder.

Description: We will describe the historical and scientific context of current research on psychedelics and review the efficacy data for classic psychedelics in the treatment of substance use disorders. We will discuss what recent preclinical and mechanistic clinical research can tell us about how classic psychedelics may work in the treatment of AUD, and consider possible future directions for research to answer the “burning questions” in the field.

Title: Psilocybin-Induced Neuroplasticity in the Treatment of Major Depressive Disorder: An Exploratory Placebo-controlled, Fixed-order Trial

Description: Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature and mechanisms of action remain unclear. This talk presented the methods and results of an exploratory placebo-controlled, fixed order study of psilocybin-assisted therapy among individuals with moderate to severe major depression (n=19). The study aimed primarily to investigate the role of neuroplasticity and psychological flexibility as mechanisms of change.

Title: Psilocybin Mushrooms and their Tryptamines: Potential Medicines for Neurogeneration

Description: The recent upsurge in interest in psilocybin mushrooms by the scientific community is attributable to their long use in history, their widespread use today, and the increasing number of clinical studies validating psilocybin as a breakthrough medicine. What is not yet well elucidated is the efficacy of microdosing and the mechanisms of action for neurogenesis and neurogeneration.

Paul speaks of their historical use and then explores psilocybin's potential for neurological health based on recent results on molecular modes of action which our team has discovered. As co-founder of MycoMedica Life Sciences, PBC (www.mycomedica.com), which has raised $60 million, his team is well positioned for conducting clinical studies based, in part, on the 3 composition patents recently awarded to Paul on his psilocybin discoveries.

Title: Placebo, expectancy, and psychotherapy effects in psychedelic-assisted therapy

Description: This talk covered the challenges and biases that confound clinical trials with psychedelics, including the challenges of executing placebo-controlled research. It examined how many of these challenges are shared by the broader field of general psychotherapy research, and some of the debate and solutions that have emerged from that body of work. We also discussed the debate around the concept of placebo in interventions that employ psychotherapy. Finally, we reviewed implications of these concepts for future research and potential solutions.

Title: Psychedelics in the brain: An overview of neuroimaging studies

Description: This talk provides an exhaustive overview of neuroimaging data on psychedelics. It is divided in three parts: 1) from receptors to brain effects, 2) from brain to cognition, 3) from neurobehavioural effects to theoretical models.

In a first part, we describe psychedelic effects on brain networks, brain oscillations, signal complexity/entropy and on some specific functions such as emotional processing, social processing, surprise processing.

In the second part, we try to predict their cognitive effects based on their brain effects and compare those predictions to actual findings.

In the third part, we summarize existing models to explain psychedelic effects and propose another angle of description of their effects based on the theoretical models of consciousness.

Title: Epistemic change and transformation

Description: Certain types of life experiences can be transformative, both epistemically and personally. By transforming you, they change how you think and value, and in the process, they restructure the nature and meaning of your life. L.A. discussed the nature of transformative change, with particular attention to how it involves a distinctive kind of epistemic revision that may be helpful in framing the epistemology of psychedelic experience. L.A. also discussed connections to philosophical issues that arise with informed consent, advance directives, and disability.

Title: Dose-Related Safety, Tolerability, and Efficacy of Dimethyltryptamine (DMT) In Healthy Volunteers and Individuals with Major Depressive Disorder – preliminary findings

Description: Dimethyltryptamine (DMT) is a potent, rapid-onset and short-acting psychedelic drug that has not yet been independently tested for the treatment of depression. The safety, tolerability, and efficacy of intravenous DMT were investigated in treatment-resistant individuals with major depressive disorder (MDD) and healthy controls (HC) in an open-label, fixed-order, dose-escalation (0.1 mg/kg followed by 0.3 mg/kg) study that was conducted in a typical hospital setting with strategic psychoeducation/support, but minimal psychotherapy. Tolerability, safety, cardiovascular function, abuse liability, psychedelic and psychotomimetic effects, mood, and anxiety were assessed at each dosing session. In addition, depression was measured in MDD participants 1 day after each dosing session. Preliminary findings (n=10) were discussed.

Title: Mapping neuro-behavioral heterogeneity of psychedelic neurobiology in humans

Title: Regulatory Approval and Implementation of Psychoactive Therapies for Psychiatric Disease: Lessons Learned from Esketamine

Description: The first half of this discussion summarized the key principles and lessons learned from the approval and implementation of esketamine and how we might apply this to future therapies which are administered under strict regulatory control. In the second half, we discussed the findings of a newly reported (top-line results) trial on psilocybin (COMPASS).