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1 Introduction and Background
Pages 1-8

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From page 1...
... , nearly one in five Americans live with a diagnosed mental illness.2 Yet, conventional medications for mental illnesses often fail to relieve patients of disruptive and disabling symptoms. It has long been known that the classic psychedelics (namely, l­ysergic acid diethylamide [LSD]
From page 2...
... While optimism about the use of psychedelics and entactogens is warranted by the data available, Gerard Sanacora, Gross Professor of ­Psychiatry at the Yale University School of Medicine and workshop co-chair, said this optimism must be balanced with concerns about the complexity, ethics, licensing, regulatory oversight, public health, and health equity. "We still have a long way to go," he said, cautioning against letting the excitement surrounding potential clinical benefits get too far ahead of actual clinical efficacy and safety data.
From page 3...
... In this 2022 NIH Workshop, "psychedelics" was used in an inclusive umbrella fashion to refer collectively to the classic psychedelics (e.g., LSD and psilocybin) , dissociative anesthetics (e.g., ketamine and PCP)
From page 4...
... As it relates to addiction liability, "they can lead to repeated misuse and negative consequences, but this is distinct from the enhanced motivational drive that you see with the classical addictive drugs," said Volkow. Characteristics of psychedelics such as neuroplasticity changes, low toxicity, and addiction liability suggest potential therapeutic benefits for depression and several other psychiatric disorders, including PTSD, ­obsessive-compulsive disorder (OCD)
From page 5...
... . The ­therapeutic benefits of ketamine, a dissociative anesthetic with psychedelic properties, was discussed in a prior National Academies workshop proceed ings, and was therefore not addressed again here.7 ORGANIZATION OF THE PROCEEDINGS Recognizing the ongoing debate in the field regarding nomenclature, for the purposes of this workshop and proceedings, "psychedelics" is used to refer to hallucination-inducing drugs with a mechanism of action that is thought to be primarily mediated through 5HT receptor agonism.
From page 6...
... -- 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: • Review the current state of knowledge regarding the mechanisms of action and pharmacokinetic/pharmacodynamic properties of these com pounds, including considering the impact of polypharmacy; • Discuss the current evidence on the clinical efficacy of psychedelics and entactogens to treat psychiatric conditions, including: o Exploring the role of adjunctive psychotherapy, o Whether hallucinogenic and dissociative side effects are essential to treatment efficacy, and o Clarifying the importance of psychosocial contexts; • Consider the role of biomarkers to target treatments, stratify patients, and predict safety profiles; • Explore appropriate clinical trial design, the need for standardization of treatment regimens, the challenge of blinding and accounting for placebo effects, and regulatory considerations; • Discuss the impacts of these compounds' legal status and scheduling classifications on research; • Explore questions of biomedical ethics such as those regarding patient protections and consent, standards of clinical training and quality assur ance, off-label use, equitable access to treatment options, and engage ment with public interest and experimentation; and • Discuss open research questions, policy needs, and opportunities to move the field forward.
From page 7...
... During the workshop, public attendees were able to ask questions and submit comments via an online chat platform, which were later posed by session moderators in the open panel discussions. These discussions are captured throughout this proceedings.


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