Parsa Yousefi, Kenneth Shinozuka, Patrick Vizeli et al.
Psychoactive drugs profoundly alter consciousness, but the neural mechanisms by which they do so remain poorly understood. Global workspace theory may provide a framework for investigating these mechanisms. The global workspace, a candidate neural substrate of consciousness, is a set of brain regions that integrate and disseminate information to the rest of the brain. According to a recent...
Manoj K. Doss, Harriet de Wit, David A Gallo
preprint
Psychoactive drugs modulate learning and emotional processes in ways that could impact their recreational and medical use. Recent work has revealed how drugs impact different stages of processing emotional episodic memories, including encoding (formation of memory traces), consolidation (stabilization of memory traces), and retrieval (accessing memory traces). Drugs administered before encoding...
Vincent Joralemon
preprint
The term “psychedelic” lacks a consensus definition, yet a growing body of regulatory and commercial infrastructure—FDA clinical-trial guidance, AMA reimbursement codes, research grants, and insurance coverage decisions—turns on whether a given substance falls within the category. This short essay argues that the boundaries of the “psychedelic” label are doing significant normative work that is...
Vincent Joralemon
preprint
FDA REMS and ETASU for psychedelic therapy—psilocybin, MDMA, and Spravato (esketamine)—can enhance safety yet impose clinic-only administration that limits access. Using Spravato’s REMS as precedent, this Article shows how “every-use” in-person supervision and limited distribution increase cost and strain providers even as adverse events cluster early in treatment. It proposes a...
Vincent Joralemon
preprint
Psychedelic therapies—ketamine, MDMA, psilocybin, LSD, DMT, and ibogaine—are moving from prohibition to regulated care, but commercialization hinges on FDA approval, DEA scheduling, and payor (insurance) coverage. This Article maps the U.S. regulatory labyrinth and analyzes how business models succeed or fail under these constraints. It explains bifurcated rescheduling (DEA reschedules the...
Vincent Joralemon
preprint
Clinical trials for novel therapeutics are extraordinarily expensive, and psychedelicassisted therapies pose a particular financing challenge: the underlying compounds (MDMA, psilocybin, LSD, ibogaine) are off-patent or unpatentable, limiting the traditional commercial incentives that fund late-stage drug development. This essay examines an emerging alternative-the "pseudo-nonprofit" financing...
Vincent Joralemon
preprint
As psychedelic-assisted therapies advance through the FDA approval pipeline, the question of who will pay for them is moving from academic to urgent. Experts project that MDMA-assisted therapy for PTSD will cost upwards of $11,000-$12,000 per course of treatment-a price tag that, absent insurance, places these therapies out of reach for many of the patients most likely to benefit. This essay...
Baneet Gill
Background: Alcohol use disorder (AUD) is a serious condition that affects millions worldwide and can have devastating and far-reaching health, social and economic consequences. Current treatment rates, which refer to the percentage of the total population living with AUD receiving treatment, remain low. The treatments that do exist, such as medications and behavioural treatments, are not...
Eduardo Ekman Schenberg
preprint
Between April and October 2024, expert bodies in two countries reached strikingly opposite conclusions about the therapeutic use of 3,4-methylenedioxymethamphetamine (MDMA). On the one hand, the Food and Drug Administration in the USA rejected a formal New Drug Application from a specific drug sponsor, Lykos Therapeutics, for Post-Traumatic Stress Disorder (PTSD). The decision was surprising to...
Mark A. Michaels
preprint
This client-authored, autoethnographic case study documents a 10-week course of collaborative therapy integrating EMDR, ketamine, MDMA, psilocybin, creative expression, and AI-assisted reflection and writing. Drawing on affect theory, mentalization, earned secure attachment, and Dabrowski's theory of positive disintegration, the paper analyzes how recognition of core affects, rupture-and-repair...