We Asked: When will MDMA-assisted therapy be approved by FDA?

You Answered:

• First half of 2024 (11%)
• Second half of 2024 (50%)
• 2025+ (33%)
• Not sure (6%)

“The court documents said he also told police that he had taken “magic mushrooms” for the first time, ingesting them about 48 hours before boarding the plane.”

The story has caused quite a stir, with mainstream media covering it widely and psychedelic advocates bracing for backlash.

Perhaps relatedly, a union representing many U.S. flight attendants (the Association of Flight Attendants-CWA) issued a ‘Know the Facts’ piece about microdosing psychedelics. It’s strange they chose to focus on microdosing.

“Organizers have collected more than 75,000 signatures on a ballot initiative to legalize psychedelic mushrooms.”

The DEA failed to provide adequate justification for its denial of a psilocybin rescheduling petition put forth in the AIMS v DEA case, the U.S. Court of Appeals for the Ninth Circuit court has found. The ruling does not send the petition to HHS for review, however. Rather, it orders DEA to provide an adequate justification for its denial.

Beckley Waves co-founder Daniel Love will act as interim CEO of NueCo Holdings PBC, a newly-formed company that will acquire the assets of Nue Life Health Inc.

“The state has pioneered a therapeutic market for psychedelic mushrooms. Researchers are watching with a mix of excitement and unease.”

As reported last week, a $16m donation from the Gracias Family Foundation has launched a new interdisciplinary program. The Harvard Crimson shares a little more about the initiative.

Blunt is a key proponent of drug policy reform, including psilocybin rescheduling, in the UK.

“Juniper Preserve, a 36-hole resort in Oregon, is applying for permission to conduct research on the performance effects of psilocybin on golfers, which is all to say, the term golf trip could be on the verge of acquiring new meaning.”

The proposed ballot measure, the “Psychedelic Wellness and Healing Initiative of 2024”, would legalise the production, use and – eventually – sales of psychedelics including psilocybin, MDMA, DMT, ibogaine, mescaline and LSD.

The draft text of the ballot measure can be read here.

“Consumption of this substance has reached its highest point since 2017 and is leaving a mark on popular culture. Some defend its therapeutic power, but others warn of its destructive potential”

Otsuka has completed its acquisition of Mindset.

50-minute radio segment, including clips from Psychedelic Science 2023.

50-minute radio segment, including clips from Psychedelic Science 2023.

Beckley’s Phase 2b trial aims to enrol 225 patients across 40 sites in 6 countries. Initial results are expected toward the end of next year.

(Radio segment: 1 hour.)

“A lack of commercial incentives to get the drug approved for treatment-resistant depression means people cannot afford it”

The Australian Capital Territory has now decriminalised small quantities of drugs including LSD, MDMA and psilocybin.

(We first reported the decision in October 2022.)

WPR speaks to Sutton King.

On Monday evening Roland Griffiths, a pioneer in psychedelic and consciousness research, passed away.

Professor David Nutt shared:

A sad day: my longtime friend and colleague Roland Griffiths died last night after a long battle with cancer during which he showed the inspiring courage and wisdom that characterised his whole career, especially in resurrecting psychedelic research. A truly great scientist.

An interview between Roland and his wife, Marla, and Manish Agrawal displays the pair’s remarkable sense of perspective on Roland’s diagnosis and beyond.

Beyond his immense impact on the present field of psychedelic and consciousness research, his legacy includes The Roland R. Griffiths, PhD, Professorship Fund in Psychedelic Research on Secular Spirituality and Well Being. The Fund establishes (and aims to support, in perpetuity) a world-class psychedelic research program to advance human flourishing and wellbeing.

The ↗ New York Times remembered Griffiths in an article that charts his contributions.

…as did the ↗ Baltimore Banner.

↗ Johns Hopkins shared a tribute to Griffiths, too, which noted that the endowment is at $24 million.

We will soon be opening a limited number of sponsorship opportunities for the Psychedelic News Feed. Get in touch to discuss.

Announces First Patient Enrolled in FDA-authorized Study Evaluating Low-Dose Psilocybin in Human Subjects with Demoralization (Oct 17) ↗ Press Release

The trial hopes to enrol 60 patients to evaluate low-dose psilocybin in demoralisation (which includes feelings of hopelessness and meaninglessness). Diamond does not expect the doses to produce subjective effects.

Pα: Given the dearth of clinical trials evaluating ‘microdosing’, and the equivocal nature of observational studies regarding the practice’s effects (or lackthereof), this should be an interesting study to follow (speaking of which, here’s the trial registry entry: NCT05227742). However, it is worth pointing out that the trial’s dosing protocol – which sees five drug (or placebo) administrations over as many weeks – is dissimilar to popular microdosing regiments. ∎

Reporters at The Denver Post want to know what “burning questions” its readers have about psychedelics in Colorado. (You can also let us know, and we will make sure to cover it in our Colorado Natural Medicine Health Act Tracker, in collaboration with Vicente LLP.)

“Donna Dryer has admitted to conflict of interest and boundary violations in MDMA-assisted therapy study”

Johnson and Johnson’s Q3 2023 results show $183 million in worldwide sales (the vast majority of which were in the U.S.) of Spravato in Q3 2023 vs. $100 million in Q3 2022.

A gift from the Gracias Family Foundation supports the launch of an interdisciplinary effort across the Faculty of Arts and Sciences, Harvard Law School, and Harvard Divinity School.

Quartz also covered the news: A former Tesla director is giving Harvard $16 million to study psychedelics in society and culture

The mental health focused accelerator supports companies at varying stages with a $100k investment and 9 weeks of intensive programming. More info and apply.

“Can toxic company culture be cured with mushrooms? A growing movement of leaders in the business world are willing to give it a shot.”

An attempt to roll back Australia Capital Territory’s decrim. law has been defeated 33-27.

“You can’t take drugs at Athenaeum—but you can talk all about them.”

“Now there’s Super Mario Bros. Wonder, which turns the franchise into a carnival of bizarre delights. Each level includes a wonder flower, a new mechanic that sends Mario on something like a psychedelic trip, reconfiguring the world around him — warp pipes start crawling like caterpillars, rhinos begin a stampede and some mountains gain a set of googly eyes.”

Q: Should Governor Newsom have signed SB-58 to decriminalise certain psychedelics in California?

A: Unsurprisingly, the ayes have it! 80% of you voted yes, with just 5% voting no. 15% of you sat on the fence, answering not sure.

More to come in our next Bulletin.

“Alejandra Lagunes says that psilocybin mushrooms could be a benefit to the country’s mental health crisis.”

The latest issue of History of Pharmacy and Pharmaceuticals revolves around the broad topic of ‘psychedelic capitalism’, and is edited by Neşe Devenot and Brian Pace.

Open Access articles include Matthew Baggott’s rich review of the STP crisis and Shams et al.’s look at the role prior art libraries (in this case, Porta Sophia) can play in the psychedelic patent landscape.

A 30-minute interview with Andy Mitchell, who just published Ten Trips.

This piece provides a summary of a (well, the) psychedelics panel at HLTH in Las Vegas.

“Coming into the sixth month of work, Colorado’s regulated natural medicine program is starting to take shape”, writes Jeff Fitzgerald of Vicente LLP for the latest update from the state’s Natural Medicine Advisory Board.

While comments on ‘giving MDMA to kids’ have caused some hoopla on the conference circuit, if MDMA-assisted therapy is approved in adults then exploring it in adolescents may be the next step on the clinical research agenda. Two researchers published a review article on the topic today, Tuesday 10th (they published a preprint in the Summer).

See our earlier coverage of MDMA-AT’s potential pediatric studies.

“While abandoning mainstream religious affiliation, many turn to alternative expressions, including secular, atheist and psychedelic churches.”

JHU is exploring a reboot of its postwar science TV show, “The Johns Hopkins Science Review”, on a platform like Netflix, and psychedelic research could get airtime: “Psilocybin research and the groundbreaking work of the School of Medicine’s Center for Psychedelic and Consciousness Research is another topic of interest”, the article notes.

Via our Psychedelic Job Board

Manager/Sr. Manager Medical Information – MAPS PBC

Research Officer – Clinical Psychedelic Lab – Monash University

Director, IT – COMPASS Pathways

“There’s a growing movement among religious leaders to use psychedelics like psilocybin to deepen their faith. The author attended a secret ceremony to find out whether it works.”

Pα: (We will be covering this more extensively in a forthcoming Bulletin – sign up today.) The Governor’s veto is not entirely surprising, given Newsom’s rumoured national political ambitions. Newsom’s associated letter (which is not something a Governor has to accompany a veto with) doesn’t slam the door closed on psychedelic policy reform, either. But it’s clear Newsom would like to see something more closely focused on ‘therapeutic use’, though the term is admittedly vague. Expect to see Sen. Wiener return next year with a new Bill. Our Editor-at-Large Graham Pechenik and I (Josh Hardman) spoke to Wired about the news. ∎

Pα: 3 years ago, Mydecine Innovations Group appointed advisors for a ‘planned listing’ on the London Stock Exchange. That never happened, but earlier this week the company was admitted to the AQSE growth market. Since then, not a single share has been traded. ∎

“Psychedelics are hot in the field of mental health!”, Tweeted the European College of Neuropsychopharmacology alongside a photo of a packed conference hall.

Pα: Our own Josh Hardman attended ECNP’s New Frontiers meeting in France earlier this year, which was entirely dedicated to psychedelics (read our write-up). It’s great to see this interest borne out at the main conference, too. ∎

Videos of presentations at MAPS’ Psychedelic Science 2023 conference are being made available via a dedicated website. Josh’s State of the Psychedelic Sector presentation is among the available recordings.

“Back then, they were associated with a hippy, psychedelic counterculture, and their popularity was given a boost not only by Starr but also Paul McCartney, who had lava lamps on stage with his band Wings, and David Bowie, who was photographed with one in his recording studio.”

Alexis Goosdeel, Director of the European Monitoring Centre for Drugs and Addiction, will present a talk titled, “From entertainment to therapeutic use: effectiveness of psychedelics and cannabis for healthcare”.

“Drugs such as psilocybin can trigger dangerous psychotic experiences and should only be used with medical supervision, warns psychiatrist Jonathan Iliff at New Scientist Live”

Pα: A number of researchers that work with psychedelics have shared concerns around topics like decriminalisation and ‘self-medication’ of late. In response to a WaPo Opinion piece titled “Self-medication with psychedelic drugs is a dangerous plan”, Robin Carhart-Harris said, “I tend to agree”. Jennifer Mitchell, meanwhile, told the LA Times she was against California’s decrim. bill. ∎

Is ibogaine R&D an appropriate use of the state’s Opioid Abatement Advisory Commission funds? A $42m grant would be its biggest to date, by a long shot.

Cameron’s ibogaine initiative “came out of the blue” and “caught everybody off-guard”, according to a source in a Daily Beast exclusive, which alleges conflicts of interest.

Pα: Just as psychedelic advocates question Newsom’s motives for vetoing SB 58, this reporting questions the motives behind KY’s potential ibogaine funding. Opposition researchers have requested ibogaine program-related records from Cameron’s office, so there may be more to come. ∎

Health Canada has given the go-ahead for a Filament-sponsored study of psilocybin for the treatment of opioid use disorder. The Phase 2 trial will take place at University of British Columbia

Pα: In a crowded synthetic psilocybin drug development space, Filament is looking to differentiate itself by using a ‘botanical’ psilocybin candidate. ∎

The case report details how a 49 year old immunocompromised male ended up with a fungal infection in his lungs.

The patient explained that he had cultivated his own psilocybin mushrooms and turned them into a powder using an electric coffee grinder.

“…just three blocks from Grand Central Terminal, tucked within the sprawl of advertising offices, finance firms and chain stores, a community center dedicated to consciousness-altering substances has taken root.”