Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
What is an “embedded” brain?
Over the last decade or so, researchers have posited various theories about how psychedelics work in the brain. One dominant theory, first proposed by now UCSF researcher Robin Carhart-Harris and colleagues, is the entropic brain theory: that psychedelics disrupt the typical connectivity patterns within certain brain regions and increase communication across brain areas. (Some researchers have interpreted this increased entropy to be a manifestation of the brain shaking off its usual patterns, and making way for healing.)
A new study published this week in Nature takes the entropic brain theory a step further, positing that this entropy is not random, but structured and organized according to its environment. For example, when participants under the influence of psilocybin watched a video, their fMRI and EEG data looked different from when they were meditating, resting, or listening to music.
The researchers reported that half of the 62 participants in the study — none of whom had previous experience with hallucinogens — said their psilocybin trip was among the most meaningful experiences of their life, and many reported feeling unity with the world. Those who reported feeling that unity also showed stronger patterns matching their brain activity to outside stimulus. To further operationalize this concept, the researchers call this feeling of unity “embeddedness,” which they define as “the subjective experience of being continuous with, rather than separate from, the environment” — and they argue that their data suggests that embeddedness is not just an experience, but a direct result of neural activity. Embeddedness, the authors write, “may thus reveal less about what psychedelics add to consciousness than about what ordinary neural dynamics keep apart.”
Johnson & Johnson to make major investment in “neuroplastogen” company Delix
On Tuesday, Psychedelic Alpha reported that pharmaceutical giant Johnson & Johnson is expected to lead Delix Therapeutics’ $85 million Series C funding round. Delix is known for its development of what it calls “neuroplastogens” or drugs that are chemically similar to psychedelics but are engineered to remove common psychedelic effects including hallucinations. (For more on neuroplastogens, read our 5 Questions interview with Delix co-founder and UC Davis professor David Olson.)
It’s been a quiet few months for Delix; the last major news from the company came in October 2025, when it announced preliminary results from a Phase 1B study using a drug called zalsupindole, or DLX-001, to treat people with major depressive disorder. DLX-001 is an analog of 5-MeO-DMT. Those initial results found that participants showed a roughly 50% overall reduction in depression symptoms after the first week of the study and none experienced serious adverse events or any experiences of hallucinations or dissociation, suggesting the drug does not cause people to trip. In addition, Delix announced that the Food and Drug Administration signed off on the design of a Phase 2 clinical trial using DLX-001 in which participants would take the drug at home.
Psychedelic Alpha reports that the financing for the deal has not yet closed, but that terms would include a right of first negotiation after DLX-001’s Phase 2 data. It’s an interesting move from Johnson & Johnson, who also developed the esketamine nasal spray Spravato, especially as other large pharmaceutical companies have also recently purchased psychedelics companies (Eli Lilly acquired AtaiBeckley last month, while Otsuka bought Transcend Therapeutics in March and AbbVie acquired rights to Gilgamesh’s bretisilocin last year.)
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University of Miami gifts Trump Administration accelerated path to research ibogaine
On Tuesday, President Donald Trump published a note on his social media site Truth Social announcing that the University of Miami gave Health & Human Services Secretary Robert F. Kennedy “its original 1994 ibogaine Investigational New Drug application” or IND. In order to study experimental drugs like psychedelics, researchers need to apply for an IND from the U.S. Food and Drug Administration showing preclinical data with non-human animals suggesting the drug is safe to test in humans, and protocols for future studies. In 1993, Deborah Mash, a professor at University of Miami and now the CEO of noribogaine company DemeRx, received IND approval from the FDA for her early studies of ibogaine. Ibogaine is a psychoactive compound that comes from the Tabernanthe iboga shrub, which grows in central and west Africa.
Trump wrote that the gift will accelerate the development of ibogaine which researchers are interested in studying as a potential addiction and PTSD treatment. In theory, the transfer precludes the federal government from having to apply for another IND for ibogaine, allowing federal investigators to springboard off this 30-plus year old approval to conduct further ibogaine research. In a statement shared with The Microdose, MAPS co-executive director Ismail L. Ali called the university’s decision to gift the IND to the federal government rather than a private company “a welcome gesture towards open science.”
Trump began advocating for ibogaine research in April of this year, after podcaster Joe Rogan suggested he issue an executive order focused on accelerating the development of psychedelics. Soon after, he did just that.
Oregon psilocybin program “generally safe,” according to new study
Since Oregon’s psilocybin services program launched in 2023, over 20,000 people have undergone facilitated psilocybin sessions in the state. A new study led by researchers at Oregon Health & Science University in Portland tracked outcomes from over 300 psilocybin clients and concluded that psilocybin services are “generally safe,” and were correlated with improvements in clients’ mental health symptoms.
The results, published in JAMA Network Open, analyzed self-reported data from participants about their psilocybin experiences, including adverse reactions, benefits, safety events, and overall satisfaction with their session. Most participants — 97.5% — reported receiving high-quality services, and 92.2% said they benefited from their psilocybin session. Clients’ average depression symptoms also decreased in the one to three months after their sessions.
Adverse reactions were relatively rare: four clients, representing just 1.2% of the study pool, experienced serious adverse reactions in the weeks or months after their session, with another seven (2%) experiencing vomiting or nausea during their session. But the researchers also reported that some clients reported worsening depression — 14 people, or 4.5% of the study pool, reported this three months after their session — and at that 3-month mark, 6 people (1.9%) experienced new suicidal ideation. State mandates only require collecting safety information for events occurring three days after sessions, so as a result, the researchers recommend providing ongoing follow-ups to track and help clients experiencing difficulties and recommend that “states seeking to implement psychedelic services should assess longitudinal client safety and outcomes in the months following receipt of state-regulated services.”
New Mexico begins accepting psilocybin producer applications
On Monday, New Mexico’s Medical Psilocybin Program announced the opening of its online application portal for aspiring medical psilocybin producers. New Mexico is in the process of becoming the third state with a state-legal psilocybin program, but unlike its predecessors Oregon and Colorado, New Mexico’s program allows only for medical psilocybin.
Also unlike Colorado and Oregon, the state’s official psilocybin producer rules do not specify that cultivators and manufacturers can only use Psilocybe cubensis; instead, the rules only dictate that cultivators identify the species name and cultivars in each product. Otherwise, it seems the state has largely followed in the footsteps of the other two states, banning synthetic psilocybin and laying out many of the same standards for product testing, storage, and transportation.
In December 2025, the state announced it would cut its two-year launch timeline in half, aiming to start seeing patients in December 2026.
Phoenix NPR affiliate KJZZ reports that Arizona’s health department has awarded a $5 million grant to the Barrow Neurological Institute and Arizona State University to study ibogaine in the treatment of PTSD and brain injury. The money came from a 2023 appropriations bill that earmarked the money for ibogaine research.
Last week, the U.S. Drug Enforcement Administration announced that 39-year-old Deontae Alexander pled guilty to intent to distribute three kilograms of MDMA. The timing of the announcement points to the schism between the recreational and the medical view of these drugs from the federal government given that Resilient Pharmaceuticals (formerly Lykos) is reapplying to have MDMA become an FDA-approved drug at the same time that Alexander faces up to 20 years in federal prison and a fine of up to $1 million.
In early August, Puerto Rico Governor Jennifer González-Colón signed an executive order promoting the development of clinical trials for emerging therapies, including psychedelics.
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