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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
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B

Workshop Agenda

Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders

March 29–30, 2022

Statement of Task

A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and conduct a 1.5-day virtual public workshop that brings together experts and key stakeholders from academia, government, industry, and non-profit organizations to explore the use of psychedelics and entactogens—including LSD, psilocybin, and MDMA—as treatments for psychiatric disorders, such as major depressive disorder, anxiety disorder, posttraumatic stress disorder, and substance use disorders. Invited presentations and discussions will be designed to:

  1. Review the current state of knowledge regarding the mechanisms of action and pharmacokinetic/pharmacodynamic properties of these compounds, including considering the impact of polypharmacy.
  2. Discuss the current evidence on the clinical efficacy of psychedelics and entactogens to treat psychiatric conditions, including:
    1. exploring the role of adjunctive psychotherapy,
    2. discussing whether hallucinogenic and dissociative side effects are essential to treatment efficacy, and
    3. clarifying the importance of psychosocial contexts.
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
  1. Consider the role of biomarkers to target treatments, stratify patients, and predict safety profiles.
  2. Explore appropriate clinical trial design, the need for standardization of treatment regimens, the challenge of blinding and accounting for placebo effects, and regulatory considerations.
  3. Discuss the impacts of these compounds’ legal status and scheduling classifications on research.
  4. Explore questions of biomedical ethics, such as those regarding pxatient protections and consent, standards of clinical training and quality assurance, off-label use, equitable access to treatment options, and engagement with public interest and experimentation.
  5. Discuss open research questions, policy needs, and opportunities to move the field forward.

The planning committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

DAY 1, MARCH 29, 2022

9:30am EST Welcome and workshop overview, 10 min
Sarah H. Lisanby, National Institute of Mental Health (NIMH), Workshop Co-Chair
Gerard Sanacora, Yale School of Medicine, Workshop Co-Chair

Session 1: An Introduction to Psychedelics and Entactogens as Treatments for Mental Health Conditions

Objectives:

  1. Preview the key focus areas to be covered in the workshop.
  2. Provide a high-level overview on the history of psychedelic medicine as treatments for mood and substance use disorders.
  3. Highlight testimonials from individuals who can speak to the subjective experience of clinical treatment with these agents.
9:40am Session overview, 5 min
Moderator: Sarah H. Lisanby, NIMH, Workshop Co-chair
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
9:45am Overview on the history of psychedelics and MDMA as treatments for psychiatric disorders, 15 min
Speaker: Charles Grob, University of California, Los Angeles (UCLA)
10:00am Personal perspectives on clinical treatment with psychedelics and MDMA, 20 min
Speakers:

Nora Osowski, MPH

Lori Tipton, Psychedelic Society of New Orleans, Louisiana

10:20am Audience Q&A, 5 min
10:25am Break, 10 min

Session 2a: State of the Evidence on Mechanisms of Action and Key Research Gaps for Classic Psychedelics and MDMA

Objectives:

  1. Review the state of knowledge regarding the acute and enduring molecular and circuit mechanisms of action, and the state of knowledge by which psychosocial contexts modulate those mechanisms.
  2. Provide a summary from the January 2022 NIMH psychedelics workshop: What key research gaps were identified?
10:35am Session overview, 5 min
Moderator: Rita Valentino, National Institute on Drug Abuse (NIDA)
10:40am Overview of the state of knowledge on molecular mechanisms of action, 20 min
Speaker: Gabriella Gobbi, McGill University
11:00am Overview of the state of knowledge on circuit mechanisms of action, 20 min
Speaker: Katrin Preller, Yale School of Medicine/University of Zurich
11:20am Overview of the state of knowledge on the neuroplastic effects, 20 min
Invited speaker: David E. Olson, University of California, Davis
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
11:40am Overview of the state of knowledge on the role of psychosocial contexts, 20 min
Speaker: Rosalind Watts, Synthesis Institute
12:00pm Summary of research gaps identified in the January 2022 NIH psychedelics workshop, 10 min
Speaker: Nora Volkow, NIDA
12:10pm Audience Q&A, 20 min
12:30pm Lunch, 1 hr

Session 2b: Exploring Critical Research Gaps and Opportunities

Objectives:

  1. Explore critical research gaps that need to be addressed to advance the field and discuss potential opportunities for action, including:
    1. What are the interactions between molecular/circuit mechanisms and the psychosocial context?
    2. During treatment, what other aspects of the patient’s psychoemotional state are being modified (e.g., changes in beliefs, social bonding, consciousness, and spirituality), and what are the implications?
    3. Is the hallucinogenic/dissociative experience part of the therapeutic mechanism of action and what are the implications?
1:30pm Session overview: John Krystal, Yale School of Medicine, 5 min
1:35pm Panel discussion: Exploring three key research gaps, 60 min Panelists:

Javier Gonzalez-Maéso, Virginia Commonwealth University

Roland Griffiths, Johns Hopkins University

Tristan McClure-Begley, Defense Advanced Research Projects Agency

Robert Malenka, Stanford University

Gitte Moos Knudsen, University of Copenhagen

2:35pm Audience Q&A, 10 min
2:45pm Break, 10 min
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×

Session 3: Key Opportunities to Advance Clinical Development

Objectives:

  1. Provide an overview of the current evidence of clinical efficacy of psychedelics and entactogens to treat mood and substance use disorders.
  2. Discuss key regulatory considerations.
  3. Explore two challenges/questions that are critical for moving this field forward, and discuss potential opportunities for action.
2:55pm Moderator introductions, 5 min
Moderator: Gerard Sanacora, Yale School of Medicine, Workshop Co-Chair
3:00pm Landscape view of evidence of clinical efficacy, 20 min
Invited speaker: Collin Reiff, New York University, Langone
3:20pm Key regulatory considerations, 20 min
Speaker: Javier Muñiz, Food and Drug Administration (FDA)
3:40pm Break, 5 min
3:45pm Panel discussion: Major challenges for clinical development, 60 min
  1. How should clinical trial designs evaluate the impact of the non-pharmacological factors (e.g., guided treatment sessions [in-person versus digital administration; individual settings vs. group settings])
  2. How can clinical trial design address challenges related to blinding, active comparators, expectancy effects, and placebo effects?
Panelists:

Collin Reiff, New York University, Langone

Javier Muñiz, FDA

Luana Colloca, University of Maryland

Srinivas Rao, atai Life Sciences

Charles Raison, Usona Institute/University of Wisconsin–Madison

Steven Levine, COMPASS Pathways

Corine de Boer, Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
4:45pm Audience Q&A, 10 min
4:55pm Concluding remarks, 5 min
Speakers: Gerard Sanacora, Yale School of Medicine, Workshop Co-Chair
5:00pm Adjourn

DAY 2, MARCH 30, 2022

10:00am EST Welcome, recap of day 1 themes, 10 min
Gerard Sanacora, Yale School of Medicine, Workshop Co-Chair

Session 4: Anticipating Implementation to Guide Clinical Research and Development

Objectives:

  1. Identify anticipated implementation issues for psychedelic medicines and related treatments (should they be approved?), and discuss how these considerations should be used now to guide clinical development by exploring these discussion questions:
    1. How does the legal status of these agents shape the path to clinical implementation?
    2. What are the implications of possible abuse, misuse, and off-label use? Lessons learned from esketamine as a case study to compare with MDMA.
    3. What special bioethical and patient protection risks may arise during implementation (e.g., need to prevent the sexual abuse and exploitation of a patient’s psychoemotional vulnerability), and how can risk mitigation approaches be studied during the rollout?
10:10am Session Overview, 5 min
Moderator: Paul Appelbaum, Columbia University
10:15am Frameworks for accessible and equitable implementation, 20 min
Speaker: Melissa A. Simon, Northwestern University
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
10:35am Panel discussions: Critical challenges for implementation, 70 min
Panelists:

Melissa A. Simon, Northwestern University

Anthony Coulson, Drug Enforcement Administration (retired)/NTH Consulting, Inc.

Dominic Sisti, University of Pennsylvania

Charma D. Dudley, National Alliance on Mental Illness (NAMI)

Caroline Dorsen, Rutgers University School of Nursing

Steven Levine, COMPASS Pathways

11:45am Audience Q&A, 15 min
12:00pm Lunch, 30 min

Session 5: Synthesis and Next Steps

Objectives:

  1. Synthesize key themes from the workshop.
  2. Discuss critical research gaps, next steps, and promising opportunities for future action.
12:30pm Session overview and synthesis of workshop’s key themes, 15 min
Moderator: Sarah H. Lisanby, NIMH, Workshop Co-Chair
12:45pm Panel discussion—Emerging themes and the road ahead, 55 min Panelists:

Daniel Karlin, MindMed

Sean Belouin, Substance Abuse and Mental Health Services Administration, U.S. Public Health Service

Walter Dunn, UCLA

Shirley Holloway, NAMI

Joshua Gordon, NIMH

Nora Volkow, NIDA

1:40pm Audience Q&A, 15 min
1:55pm Concluding remarks, 5 min
Sarah H. Lisanby, NIMH, Workshop Co-Chair
Gerard Sanacora, Yale School of Medicine, Workshop Co-Chair
2:00pm Adjourn
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×

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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
Page 77
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
Page 78
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
Page 79
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
Page 80
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
Page 81
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2022. Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26648.
×
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Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop Get This Book
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Psychiatric illnesses - such as major depressive disorder, anxiety disorder, substance use disorder, and posttraumatic stress disorder (PTSD) - are widely prevalent and represent a substantial health burden worldwide. Yet, conventional medications for mental illnesses often fail to provide relief to patients' disruptive and disabling symptoms. Existing and emerging evidence that psychedelics (e.g., LSD and psilocybin) and entactogens (e.g., MDMA) may be useful as tools to alleviate mental illness has sparked a renaissance of interest by investigators, clinicians, drug developers, and patient advocates in recent years. While promising data on therapeutic efficacy has energized research and development, resolving the mechanisms of action will be important for optimizing the efficacy and safety of these medicines. Further, evaluating the effect of psychedelics and entactogens on mood and behavior comes with unique challenges still in need of resolution. These include unresolved questions relating to blinding, placebo and nocebo effects, and the impact of psychosocial contexts.

In response to this renewed interest, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop on March 29-30, 2022. The workshop brought together a diverse group of stakeholders to explore the use of psychedelics and entactogens as treatments for psychiatric disorders. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop.

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