A Two-Hour Psychedelic Session, and What 25,419 Support Calls Reveal
A Two-Hour Psychedelic Session, and What 25,419 Support Calls Reveal
A nasal spray trial in six countries, redosing without consent, a drug-law rewrite, Europe’s clinics
Most of what I read this week happened outside the six-hour clinic session. A single nasal spray of 5-MeO-DMT had most trial patients ready to leave within two hours. A support line’s 25,419 calls logged 43 people dosed without consent at retreats and ceremonies. A House bill would hand US drug scheduling to HHS, and federal officials are drafting safety plans before approval.
A single psychedelic nasal spray had most patients ready to leave within two hours
A single spray of mebufotenin, a synthetic form of the short-acting psychedelic 5-MeO-DMT, cut depression scores more than a near-inactive dose did in a Phase 2b trial published in JAMA last week. The sponsor is Beckley Psytech, now part of AtaiBeckley, which Eli Lilly has agreed to buy for $2.8 billion upfront.
The trial treated 193 adults with treatment-resistant depression at 38 sites in Australia, Germany, Poland, Spain, the UK and the US. Each received 8 mg, 12 mg or a 0.3 mg comparator dose as a dry powder in one nostril, with structured psychological support, after tapering off antidepressants. On the 60-point MADRS depression scale, the 12 mg group fell 11.1 points by day 29 against 5.5 for the comparator, a difference of 5.3 points. The 8 mg group did at least as well, dropping 12.5 points. Both active doses separated from the comparator by day two and stayed ahead at day 57. Remission at day 29 was 26% on 8 mg, 18% on 12 mg and 8% on the comparator.
The practical result is time. Within two hours, 85% of the 8 mg group and 78% of the 12 mg group met discharge criteria; psilocybin sessions typically run six to eight hours. Nausea hit 33% and 40% of the active groups against 3% on the comparator, and one participant had two severe panic attacks. There was no suicidal behavior. The company picked 8 mg for Phase 3.
The limits are real. Most participants and on-site clinicians guessed who got what, participants had failed a median of only two antidepressants, and sponsor staff helped design and analyze the study. In an accompanying editorial, Chittaranjan Andrade notes average improvement was about 30%, with response and remission rates below those seen with ketamine and ECT. Phase 3 is meant to follow patients long enough to show whether one short session lasts.
Sources: JAMA · PsyPost · ScienceAlert · Medscape
Women felt psilocybin and 2C-B more strongly than men at the same dose
Pooled data from two double-blind Maastricht University trials suggest women feel some psychedelics more intensely. The 72 healthy volunteers, 40 of them women, all had prior psychedelic experience. One trial gave psilocybin, 2C-B or placebo on separate days; the other gave LSD or placebo. Women reported feeling more under the influence, most clearly on psilocybin, felt less able to steer their thinking, and lost more alertness on psilocybin and 2C-B. Doses were fixed, but blood drug levels didn’t differ by sex, so body weight doesn’t explain the gap. Hormones are one candidate the study didn’t measure. It is a bioRxiv preprint, wasn’t designed to test sex differences and didn’t correct for multiple comparisons. The researchers warn against reading it as a case for lower doses in women.
Sources: ScienceAlert
Ketamine and MDMA both changed chemical tags on plasticity genes
A study in Translational Psychiatry, led by Moira Semple at Arizona State University, measured DNA methylation, chemical tags that help switch genes on and off, before and after treatment. Twenty people with depression, PTSD or both had six ketamine infusions, and 16 people with severe PTSD had three MDMA sessions with therapy in a Phase 3 trial. Across about 2,900 brain-related genes, 405 changed with ketamine and 346 with MDMA, clustering in pathways for neuroplasticity and immune and stress signaling. Only 47 genes changed in both, though both treatments raised methylation of EFNA5, a gene linked to PTSD in large genetic studies. There was no control group, samples were blood and saliva rather than brain, and the analysis didn’t test whether the changes tracked symptom relief.
Sources: PsyPost
Psilocybin made brain activity follow whatever people were doing
Devon Stoliker and colleagues gave 62 healthy adults with no meaningful psychedelic experience a single 19 mg dose of psilocybin, then recorded fMRI and EEG during rest, guided meditation, music and a film. Psilocybin didn’t simply scramble brain activity; it made activity line up more closely with the task at hand. Participants whose activity aligned most reported more positively felt dissolution of the self, stronger mystical experiences and less anxiety. Music was rated 16% to 21% more emotionally engaging on the drug. The comparison was with sober sessions rather than a placebo, and the write-up doesn’t name the journal, so the figures couldn’t be checked against the paper.
Sources: OPEN Foundation
Australia will test ketamine with exposure therapy for emergency workers with PTSD
The Black Dog Institute announced on October 27 an Australian-first trial pairing ketamine with exposure therapy, the standard psychological treatment for PTSD, for emergency service workers and volunteers whose symptoms persist despite treatment. It was unveiled in Canberra at the National Emergency Worker Mental Health Roundtable and will run through the institute’s National Emergency Worker Support Service with the UNSW Traumatic Stress Clinic. Sam Harvey, the institute’s chief scientist, said some people “continue to struggle despite receiving treatment.” Recruitment is expected to start in 2027. The announcement gave no sample size, dose, route of administration or funding figure.
Sources: News-Medical · ABC
A support line’s 25,419 calls include 43 reports of people dosed without consent
Fireside Project, the US nonprofit that runs a free peer-support line for people during and after psychedelic experiences, has released anonymized records of 25,419 interactions handled by 220 trained volunteers between April 2021 and February 2026. The dataset is described in Science Advances, in a paper led by Félix Schoeller of the Institute for Advanced Consciousness Studies.
About 40% of contacts came from people mid-trip and 32% from people working through an experience afterwards. The rest asked for information, wanted help preparing, or called on someone else’s behalf. Psilocybin came up in 9,348 interactions, LSD in 2,247, cannabis in 2,004, ketamine in 1,194 and MDMA in 682. Cannabis carried the highest distress rate, 47%, against roughly 40% to 42% for the common psychedelics.
The most serious finding is 43 cases in which callers said the person providing the substance gave them extra doses without their consent. Most happened at remote retreats or ceremonial gatherings, often involving ayahuasca, and those callers had higher rates of prior PTSD diagnoses. The authors describe it as the first quantitative record of the practice in a community help-seeking sample.
Across 2,777 satisfaction surveys, whether a call helped depended most on whether the caller saw the volunteer as genuine and empathetic.
Everything in the database is self-reported, by people who chose to call, so it can’t give a rate for any of this across all users, and the 43 accounts weren’t independently verified. The coverage doesn’t say whether any of those cases reached police or a regulator.
Sources: Science Advances · 404 Media · News-Medical
Ethicists propose a different account of consenting to a transformative experience
A conceptual commentary in the Journal of Psychedelic Studies takes on a worry often used to argue that psychedelic therapy needs its own ethical rules. Patients may undergo lasting personal changes they can’t anticipate and might later regret, which seems to undercut informed consent. The authors propose a process-based, “agency-sensitive” account instead. Rather than a single event imposed on a passive subject, they treat transformation as something that unfolds over time with the patient taking part. The argument bears on how consent forms for approved psychedelic treatments describe personality change. It is a commentary, not a study, and offers no data.
Sources: Journal of Psychedelic Studies
A House bill would hand drug scheduling to HHS and re-sort psilocybin and ibogaine
Rep. Steve Cohen, a Tennessee Democrat on the House Judiciary Committee, has introduced the Public Health and Research Reforms in Controlled Substances Act, a six-title rewrite of large parts of the 1970 Controlled Substances Act, his office announced on October 29. The release gives no bill number.
The bill would move scheduling decisions from the Attorney General to the HHS Secretary, and shift researcher registration and production quotas from the DEA to HHS. The DEA would keep diversion and trafficking enforcement. It creates new, more granular schedules, scored by an external advisory committee against a new statutory list of factors, and names about 30 substances for first review, including psilocybin, ibogaine, fentanyl, morphine and methamphetamine. None would be descheduled; each would be placed in a schedule that weighs harm against benefit.
It also creates blanket research licenses for controlled substances, removes marijuana from the Act, and ends mandatory minimum drug sentences, with retroactive effect. MAPS, Students for Sensible Drug Policy, the Drug Policy Alliance and NORML have endorsed it. Cohen called a review of national drug policy “long overdue.” The bill expands on his Controlled Substances Act Clarification in Science Act, introduced in June.
For psychedelic researchers, the licensing changes would arrive without waiting for any substance-by-substance review. The release lists no cosponsors, and Cohen’s party is in the House minority.
Sources: Office of Rep. Steve Cohen
Federal officials say the FDA has already asked developers for safety plans
Last week’s lead covered the VA’s ten-site plan from the Psychedelic Healthcare Forum in New York on October 15. A fuller account of the same day adds what the other agencies are doing before any approval. The FDA has already asked psychedelic developers for REMS proposals, the risk-management plans that set who can give a drug and where, rather than waiting for the end of review. Valentina Mantua, the FDA’s associate director for regulatory science, pointed to last year’s removal of a clozapine lab-monitoring rule that had restricted access.
CMS is planning Medicare and CPT billing codes. HHS is working with the Justice Department and the DEA so that post-approval rescheduling, which typically takes two to three months, doesn’t delay care. HRSA is expected to publish a report on workforce training within weeks. The FDA oversees about 433 psychedelic investigational new drug applications, 85% of them academic.
The FDA’s comment docket drew about 610 submissions, nearly 500 of them distinct, and was mostly supportive; much of the opposition came as template letters. A separate, LLM-assisted content analysis of 591 unique submissions has been posted on OSF. Matt Zorn, the HHS deputy general counsel, expects adverse event rates after approval to run higher than in trials.
Sources: Lucid News · Psychedelic Alpha · OSF
An Iowa ayahuasca church says the DEA has granted its exemption
The Iowaska Church of Healing in Des Moines says it has received a religious exemption from the DEA for its sacramental use of ayahuasca, according to an October 26 report. The church’s attorneys announced an agreement with the DEA that Monday, after years of litigation against federal regulators. On October 19 we reported that the church had cleared the Iowa Board of Pharmacy, with federal registrations still to come. The church applied to the DEA in 2019, and the IRS denied it tax-exempt status because its sacrament was illegal without that exemption. The agreement’s terms are sealed.
Helus Pharma’s co-founders step back before its Phase 3 readout
Eric So and Paul Glavine, co-founders of Helus Pharma, formerly Cybin, are leaving their executive and consulting roles and will stay on the board, the company said on October 27. So, who had been president and executive chairman, becomes chairman emeritus. Glavine had been chief growth officer since 2021. Board member Mark Lawson becomes independent chair, and Michael Halstead stays on as chief executive. The company still expects topline data in the fourth quarter of 2026 from APPROACH, its pivotal Phase 3 trial of HLP003 in major depressive disorder.
Sources: GlobeNewswire via The Manila Times
Optimi sets up an Australian distribution arm
Optimi Health has formed Optimi Australia Pty Ltd, a wholly owned subsidiary led by Adrian Jones, to build its network of clinics and pharmacies in Australia. Authorized psychiatrists there have been able to prescribe MDMA and psilocybin since 2023. Last week the Vancouver company said a new MDMA batch would supply a commercial export to Australia as well as trials in Canada and Israel. The release didn’t give staffing, sales targets or the number of prescribers or clinics the subsidiary currently serves.
Sources: GlobeNewswire via Owen Sound Sun Times
An open directory lists 487 verified psychedelic providers across 26 European countries
PsyAccess has published its catalogue of 487 registry-checked psychedelic medicine providers in 26 European countries as an open dataset under a CC BY 4.0 licence, updated in October 2026. Each entry lists provider type, country, city, treatments offered, verification level, website and the date it was last checked, downloadable as JSON or CSV. The catalogue covers licensed ketamine, esketamine and psilocybin clinics and research sites. It gives researchers and payers a free baseline for where treatment in Europe actually happens, as Norrsken Mind looks for designs for a pan-European patient registry.
Sources: PsyAccess
Americans’ views on drug laws track legal status more than harm
In Nature Human Behaviour, Bence Hamrak and Gabor Simonovits surveyed 2,016 US adults about 13 substances and compared their support for legality with expert harm ratings. Support followed current legal status: alcohol drew 71 points more support than MDMA, though experts rate alcohol as more harmful. Unnamed “off-brand” versions of legal drugs drew much less support than the real ones. In a second experiment with 3,037 people, expert harm scores cut support for legal alcohol by 18 points and tobacco by 13, but barely moved views on LSD, MDMA, cannabis or cocaine. With harm held constant, respondents favored depressants over psychedelics by 15 points. Both samples came from opt-in online panels.
Sources: PsyPost
News stories about psilocybin present early results as settled
A systematic review compared 70 psilocybin trial publications with 172 news articles about the same research. Papers and news reports described positive results at similar rates. The difference was in framing: news coverage tended to present the benefits as established and rarely mentioned that most of the trials were small and early-stage. This week’s mebufotenin coverage leaned on “toad venom” headlines more than on the trial’s 5.3-point average gap over a near-inactive dose. Readers deciding whether to book an out-of-pocket state-program session or an unlicensed retreat are mostly working from the news version, not the papers.
Sources: PsyPost · The Microdose
Foucault’s night on LSD at Zabriskie Point
Michel Foucault was born 100 years ago this October. In Chacruna, Brazilian science journalist Marcelo Leite retraces the weekend in May 1975 when Simeon Wade and Michael Stoneman took the philosopher, then a visiting scholar at Berkeley, to Death Valley and gave him LSD at Zabriskie Point, where they stayed from dusk until dawn. Foucault later called it one of the most important experiences of his life. Leite drove the route himself in April. He argues the counterculture’s shared vision of liberation was buried under individualism, and that psychedelics now arrive mainly as treatments for one person’s suffering.
Sources: Chacruna
The search for a North American psychedelic ritual
An essay on Chronicles of Kykeon opens on a rented farmhouse where a facilitator plays recorded Shipibo icaros through a Bluetooth speaker for a dozen Americans with mortgages. The Native American Church and Santo Daime, it argues, were built by people answering their own times, and copying their outward forms skips that authorship. It cites R. Gordon Wasson’s 1957 Life article, which sent seekers to María Sabina, and the strain outside demand puts on peyote. For a homegrown ritual it points to the vigil, the wake, the camp meeting, the recovery circle and the hospice bedside.
Sources: Chronicles of Kykeon
The State(s) of Psychedelic Storytelling, Lafayette, California
Psychedelic State(s) of America and the Psychedelic Writers Guild host an evening at The Shulgin Farm in Lafayette, California, on Thursday, November 5, during Global Psychedelic Week. Doors open at 5 p.m., followed by a farm and lab tour and a 7:30 p.m. storytelling panel with Annie Oak Harrison, Mareesa Stertz and Lindsay Kent. Entry is by donation, the venue holds about 50 people and parking is limited. Register on Eventbrite.
Sources: PSA
Energy, Awareness & the Nature of Mind with Shamil Chandaria, online
Meditation researcher Shamil Chandaria leads an online evening of guided meditation, discussion and Q&A on Sunday, November 15, 6 to 8 p.m. UK time, hosted by Adventures in Awareness with The Psychedelic Society. He draws on computational neuroscience, predictive processing and nondual traditions. Tickets cost £10 to £20 on a sliding scale, and registered attendees receive the recording.
Sources: Dandelion
Psychedelics and Nature symposium, online
The Psychedelic Society runs a one-day online symposium on Sunday, November 29, 11 a.m. to 4:30 p.m. UK time, with six 30-minute talks on nature connectedness, animism, Indigenous plant traditions and ecology. Speakers are Luis Eduardo Luna, David Luke, Sam Gandy, Anja Loizaga-Velder, Brian Stafford and Fernanda Gebara, chaired by ecopsychologist Adrian Harris. Tickets cost £35 to £70, reduced prices are available on request, and a recording is included.
Sources: Dandelion
The close
This week’s evidence came from both ends of psychedelic use. Inside a trial, mebufotenin needed under two hours of clinic time and still beat a near-inactive dose for eight weeks. Outside the clinic, Fireside’s volunteers logged 25,419 calls, and Americans’ support for drug laws tracked legal status more than harm. Regulators are planning for the clinical end, with REMS proposals, billing codes and a scheduling bill in the House. The 43 people dosed without consent were at retreats and ceremonies that none of those plans cover.
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