The Psychedelic News Feed Archive

December 11, 2023 - January 7, 2024

This is an archived version of our Psychedelic News Feed. Receive a weekly digest to your inbox by joining our newsletter. 

January 1 - 7, 2024

BREAKING
MAPS PBC Closes $100m Series A, Rebrands to Lykos Therapeutics
(Jan 5) ↗ Psychedelic Alpha

Here, we take a closer look at MAPS PBC’s Series A, rebrand, and what this might tell us about an organisation that so desperately wants to do things differently in an industry that’s often a case study for inertia.

Read our coverage here.

VA to fund psychedelic research (Jan 5) ↗ POLITICO Pro

“The Department of Veterans Affairs will fund research on the use of psychedelic drugs like MDMA and psilocybin along with therapy to treat post-traumatic stress disorder and depression, the agency announced Friday.”

More coverage from Government Executive: VA to begin researching psychedelics as treatment option for veterans

The full release from the VA can be read here.

Magnesium–ibogaine therapy in veterans with traumatic brain injuries (Jan 5) ↗ Nature Medicine

A heavily-anticipated open-label study from Nolan Williams et al. found that co-administration of ibogaine and magnesium led to “significant improvements in functioning both immediately … and 1 month … after treatment”, as well as in PTSD, depression and anxiety at 1 month after treatment.

The publication was covered in:

  • Scientific American: Ibogaine Shows Success in Treating PTSD
  • NewScientistPsychedelic drug helps treat PTSD and traumatic brain injuries
  • WIREDThey Had PTSD. A Psychedelic Called Ibogaine Helped Them Get Better
  • Stanford Medicine News Center: Psychoactive drug ibogaine effectively treats traumatic brain injury in special ops military vets 

BREAKING
atai Life Sciences Makes $50m Investment in Beckley Psytech
(Jan 4) ↗ Psychedelic Alpha

NASDAQ-listed psychedelic drug developer atai Life Sciences has announced a strategic investment in—and collaboration with—its British privately-held peer, Beckley Psytech.

See our coverage here.

Compass Pathways and Greenbrook TMS enter into three-year research collaboration agreement (Jan 5) ↗ Press Release

Three-year research collaboration will investigate the development of scalable, commercial delivery models for COMP360 psilocybin treatment, if FDA-approved

The wellness trends to know in 2024 (Jan 2) ↗ The Australian

The list includes psychedelics, with The Australian noting:

While only a small number of psychiatrists have been given authorisation to prescribe the substances, the change has reignited interest around psychedelics and their potential uses for combating various mental health disorders.

Drug activist draws flak for sending magic mushrooms, coca leaf to B.C. MLAs (Jan 4) ↗ CBC

“Dana Larsen, who runs the Medicinal Mushroom Dispensary in Vancouver’s Downtown Eastside, says he mailed all 87 B.C. MLAs one gram of psilocybin mushrooms and a coca leaf as “gifts” for the holidays.”

24 things we think will happen in 2024 (Jan 1) ↗ Vox

Sigal Samuel is 85% sure FDA will approve MDMA-assisted therapy for PTSD this year, according to Vox’s predictions piece.

Citing our coverage of the NDA submission, Samuel writes:

But the FDA is, um, not exactly known for speed. If it views the MAPS filing as complete, it will aim to render a decision in six to 10 months. But because this is a psychedelic drug we’re talking about, we may see extra risk evaluations, which could drag out the timeline. So although I think approval is likely in late 2024, I won’t give this prediction more than 85 percent odds.

Six Letters to the Editor discuss the role of psychotherapy in psychedelic-assisted therapy (January 2024) ↗ The American Journal of Psychiatry

The pieces respond to Goodwin et al.’s July 2023 Commentary, ‘Must Psilocybin Always “Assist Psychotherapy”?’

atai Life Sciences Announces Positive Topline Results from Single Ascending Dose Phase 1 Study with EMP-01 (R-MDMA) (Jan 2) ↗ Press Release

We found differences in the subjective experience R-MDMA in comparison to published reports involving racemic MDMA.

Tryp Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial for the Treatment of Fibromyalgia at The University of Michigan (Jan 4) ↗ Press Release

MAPS PBC Announces New American Medical Association CPT III Codes for Psychedelic-Assisted Therapies Take Effect (January 2024) ↗ Press Release

The Austin Chronic: SXSW Is High on Psychedelics, as Cannabis Programming Wanes (Jan 5) ↗ Austin Chronicle

Psychedelics Are Going Mainstream. Investing in Them Hasn’t. (Jan 5) ↗ WSJ

How psychedelic drugs are being used in the medical world (Jan 5) ↗ ABC (audio, 7 mins)

The psychedelic heart: Scientists predict DMT effects from cardiac activity (Jan 5) ↗ Big Think

Will Matthew Perry’s death spell the end of the ketamine wellness industry? (Jan 5) ↗ The Guardian

Cybin Highlights Recent Topline Results and Outlines Key Upcoming Milestones Across its Clinical Development Programs (Jan 4) ↗ Press Release

Select Board Asks State to Reconsider Supervised Use of Psilocybin (Jan 3) ↗ The Provincetown Independent

December 25 - 31, 2023

ANALYSIS
Kentucky’s $42m Ibogaine Funding Appears Dead in the Water
(Dec 29) ↗  Psychedelic Alpha

Written by Josh Hardman, this piece charts the story of the genesis through to apparent downfall of Kentucky’s supposed Manhattan Project for treating opioid use disorder: ibogaine.

Available now (free to read).

Weight loss, drug prices, abortion and prescribed psychedelics: Expect reckonings in 2024 (Dec 25) ↗  USA Today

Colorado Voters approved psilocybin mushrooms in 2022. Now the state is setting up how they’ll be regulated (Dec 30) ↗  CPR

The daughter of multi-millionaire oil tycoon Charles Koch thought she had to be liked to deserve to exist, until MDMA therapy (Dec 30) ↗ Business Insider

(Excerpt from Rachel Nuwer’s I Feel Love.)

Bringing psychedelic medicine from the margins to the mainstream (Dec 31) ↗  The Hill

With Psychedelic Treatments on Horizon, New Opportunities Coming for Behavioral Healthcare Organizations (Dec 26) ↗ Behavioral Healthcare Executive

BHE speaks with Journey Colab CEO, Jeeshan Chowdhury.

Calgary clinic pushing for better access to psychedelic therapy (Dec 26) ↗ Global News

Psychedemia: Charting the future of interdisciplinary Psychedelic Studies (Dec 29) ↗ Journal of Psychedelic Studies

A Phenomenological Report on the Novel Non-Hallucinogenic Psychedelic Tabernanthalog (Dec 27) ↗ Arthur Juliani (Substack)

“What was so unique about the Tabernanthalog is that there was only the change in attention. To be clear, this effect is not equivalent to a light dose of psychedelics, it was similar to what I might experience on 2g of psilocybin mushrooms, but only in the one limited aspect of mind: attention. While this might make it unappealing as a recreational drug (there is no “high”), this property makes it extremely compelling as a potential psychotherapeutic agent.”

See also our earlier reportingNon-Hallucinogenic Trip Reports: Searching for the Tabernanthalog Tasters.

Opinion: Psychedelics could help Utahns struggling with mental health (Dec 30) ↗ Salt Lake Tribune

December 18 - 24, 2023

EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework (16-17 April, 2024) ↗ European Medicines Agency

“This multi-stakeholder workshop will bring together patients, healthcare professionals, academia, regulators, and industry to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.”

Peyote is the darling of the psychedelics renaissance. Indigenous users say it co-opts ‘a sacred way of life’ (Dec 19) ↗  The Guardian

USask researchers explore untold history of psychedelics (Dec 20) ↗  USask

What It’s Like to Take a Psychedelic Trip Without Drugs (Dec 21) ↗  Esquire

EVENT
Legal Models for Psychedelics
(Jan 31, 2024) ↗  Penn Carey Law

Psilocybin is different to other antidepressants — the Government is blocking patients who need it (Dec 22) ↗  Evening Standard (Comment)

Relax rules on research into illegal drugs, say advisers (Dec 22) ↗  BBC

Over 700 people used psychedelic mushrooms under Oregon’s program in 2023 (Dec 19) ↗  Oregon Live

Compass Pathways announces investigational COMP360 psilocybin treatment was well-tolerated in phase 2 study of post-traumatic stress disorder (Dec 19) ↗  Press Release

Compass has shared a morsel of information regarding its COMP360 psilocybin treatment for PTSD study (N=22), announcing in an “initial data readout” that COMP360 was “well-tolerated and the safety profile was as expected” 24 hours post-dosing.

Psychedelic psilocybin-assisted therapy reduces depressive symptoms in adults with cancer and depression (Dec 18) ↗  EurekAlert

Will Psychedelics Replace Antidepressants? (Dec 20) ↗  Nautilus

Nautilus speaks to Charles Raison.

“But I’m really rooting for consciousness. I personally am greatly hoping that when we remove the conscious experience, that psychedelics will not have the signal.”

More Evidence Psychedelics Can Curb Depression (Dec 21) ↗  Psychiatrist.com

Research at the new Centre for Mental Health Research and Innovation (Dec 18) ↗ NHS South London and Maudsley

“Compass Pathways initiates UK component of global phase 3 study of psilocybin treatment in treatment-resistant depression, and launches new research center.”

Filament Health Announces Termination of Proposed Business Combination with Jupiter Acquisition Corporation (Dec 20) ↗  Press Release

The Science of Psychedelics: Research, Risks, and Therapeutic Potentials (Feb 29, 2024) ↗  APA

Continuing Education (CE) credits are available for this live webinar from the American Psychological Association.

Soul Quest Church of Mother Earth Loses Appeal Over Ayahuasca (Dec 18) ↗  Bloomberg Law

DOCUMENTARY
Contemplations: On the Psychedelic Experience ↗  Prime Video

“Contemplations is a documentary film exploring the furthest reaches of psychedelic exploration.”

Deontay Wilder claims he is ‘reborn’ after taking psychedelic South American drug (Dec 19) ↗  Independent

Are Mushrooms The Social Drug Of 2024? An Investigation (Dec 20) ↗  Refinery29

December 11 - 17, 2023

PSYCHEDELIC BULLETIN
Pα+ Psychedelic Bulletin #151: Psilocybin for BDII, ACNP Readouts, Methylone for PTSD, and More Psychedelic Drug Dev. News (Dec 14) ↗ Psychedelic Alpha

Featured content in this Issue:

  • MAPS PBC Files New Drug Application for MDMA-Assisted Therapy for PTSD
  • Compass-Sponsored Study of Psilocybin in Bipolar Type II Finds Preliminary Safety and Efficacy, Potentially Warranting Larger Trial
  • MindMed Shares Topline Results from LSD for Generalised Anxiety Disorder Study
  • Clairvoyant Therapeutics Provides Update on Ph 2b Psilocybin for Alcohol Use Disorder Trial
  • Delix Provides A First Look at DLX-001 Phase I Data
  • Intra-Cellular Therapies Presents Preclinical Data from Non-Hallucinogenic Psychedelics Program
  • Gilgamesh Wraps Phase I Trial of GM-2505
  • Cybin Provides Further CYB003 Data
  • Transcend Provides First Look at Phase 2 Methylone for PTSD Data

Read Bulletin 151 now.

BREAKING NEWS
MAPS Public Benefit Corporation (MAPS PBC) has filed a New Drug Application (NDA) with FDA for MDMA-Assisted Therapy for PTSD. (Dec 12) ↗ Psychedelic Alpha

MAPS Public Benefit Corporation (PBC) has submitted its New Drug Application (NDA) to the FDA in order to seek marketing approval of MDMA-assisted therapy (MDMA-AT) for PTSD.

The organisation and its parent non-profit, MAPS, has been conducting clinical studies of MDMA-AT for over twenty years, making this a significant milestone.

And it’s not just a milestone for MAPS: this is the first psychedelic-assisted therapy submitted to the FDA for approval.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD,” said MAPS PBC’s CEO, Amy Emerson.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health”, she continued.

More Coverage:

  • FDA to review MDMA-assisted therapy, a milestone for psychedelics (WaPo)
  • The US Is One Step Closer To MDMA Therapy (VICE)
  • FDA may review MDMA for the treatment of PTSD (CNN Health)
  • First-ever drug application for MDMA finally reaches FDA after near 40-year journey (Fierce Biotech)
  • FDA to consider psychedelic-assisted therapy for PTSD (The Hill)

Natural Medicine Advisory Bulletin #6: November 2023 (Dec 15) ↗ Psychedelic Alpha X Vicente LLP

Treat Psychedelics Like Cannabis? (Dec 13) ↗ Vital City

World-Renowned Neuroscientist Doctor Gül Dölen to Join UC Berkeley Faculty (Dec 13) ↗ BCSP

Provincetown moves to decriminalize psychedelics for adults (Dec 14) ↗ WBUR

Congress greenlights psychedelic treatment bill for active duty service members suffering from PTSD (Dec 14) ↗ The Texas Tribune

“The measure would allow supervised clinical studies with active duty members. Psychedelic treatments for PTSD have found conservative supporters in the state for years.”

DEA Again Moves to Place DOI and DOC in Schedule I of the Controlled Substances Act (Dec 13) ↗ Federal Register

The agency withdrew its earlier effort to do so in August 2022, but noted it would be back with an amended procedure.

“Perhaps this withdrawal is the product of a procedural quirk as opposed to a change in attitude from the agency”, we wrote in Bulletin 116 back in August 2022.

It certainly seems so.

Comments close on January 12th, 2024.

One has to wonder whether proposing this rule over the holidays might reduce the likelihood of significant public and industry engagement, as seen in DEA’s first attempt to schedule these substances.

Comments may be submitted here.

Magic mushroom use grows in England and Wales, ONS figures show (Dec 14) ↗ The Guardian

“Use of ecstasy and nitrous oxide falls overall and drug use of all kinds falls among younger people”.

Journal of Military, Veteran and Family Health Publishes Special Edition on Psychedelics (Dec 2023) ↗ JMVFH

Psychedelic drugs: Follow the money as investors seek to replace Prozac, Zoloft and other drugs (Dec 12) ↗ SiliconValley.com

New psychedelic-like drugs: All treatment, no trip? (Dec 12) ↗ SiliconValley.com

“More than 100 companies are focused on psychoactive drugs, according to patent attorney Graham Pechenik of the San Francisco-based Calyx Law. Five years ago, only a few dozen patent applications had been submitted for psychoactive-related products, he said. Now his Psychedelic Alpha patent tracker counts more than 1,000.”

American Psychiatrists Reveal Changing Attitudes About the Therapeutic Use of Classic Hallucinogens (Dec 12) ↗ Cleveland Clinic

Could a little-known psychedelic drug treat opioid addiction? Kentucky wants to find out. (Dec 13) ↗  NBC News

“The state is considering funding research on ibogaine, a psychedelic that’s growing in popularity as potential treatment for opioid use disorder.”

Identification of 5-HT2A receptor signaling pathways associated with psychedelic potential (Dec 15) ↗  Nature Communications

In Memoriam: Roland R. Griffiths, Ph.D (Dec 11) ↗  Neuropsychopharmacology

“Griffiths lived a remarkable and consequential life. As one young physician scientist said upon hearing of his death: he changed the world for the better.”

MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (Dec 14) ↗ Press Release

“Trial met its primary endpoint with MM-120 demonstrating a statistically significant dose-dependent improvement in HAM-A scores four weeks after a single-dose”.

Delix Therapeutics Awarded National Institutes of Health Grant to Advance Vital Research of Novel Neuroplastogen for Substance Use Disorders (Dec 13) ↗ Press Release

Delix’s ibogaine analog, DLX-007, will benefit from NIDA funding. “DLX-007 has completed IND-enabling studies and is slated for clinical testing in 2024.”

Do psychedelics have a role in psychiatric treatment? (Dec 12) ↗ UCLA Health

Exploring Psychedelics With Boris Heifets (Dec 15) ↗ Technology Networks

Police say $49K in ‘psychedelic mushroom’ products seized in raid of store (Dec 14) ↗ Global News

Sunstone Therapies Celebrates Three Year Anniversary With More Than 100 Psychedelic-Assisted Therapy Treatments Completed (Dec 14) ↗ Press Release

Apeiron’s Christian Angermayer: “AI, psychedelics and living for hundreds of years” ↗ The Sunday Times’ Danny in the Valley Podcast

Congress Is Pushing Revolutionary Research on Psychedelic Treatments for the Military (Dec 12) ↗ The Intercept

Treatment with psychedelics is psychotherapy: beyond reductionism (Dec 12) ↗ The Lancet Psychiatry

Psychedelic Toad Hunters Are Under Attack by Mexican Cartels (Dec 11) ↗ VICE

Reminder: Don’t Put Your Medical License At Risk (Dec 12) ↗ On Drugs

“Bottom line: if you are a medical professional flirting with these new systems, be careful. Certainly, dial down blasé echoing from the purveyors of the medical marijuana establishment. Get a robust and unbiased legal opinion. Don’t let someone shoot from the hip.”

To Revive Portland, Officials Seek to Ban Public Drug Use (Dec 11) ↗ NYT

“Under the plan brokered by Gov. Kotek, a Democrat, state lawmakers would be asked to consider a ban on public drug use and police would be given greater resources to deter the distribution of drugs.”

AWESTRUCK ↗ Johns Hopkins Magazines

“The scientists plan to spend another year or so slipping the VR headset on patients dosed with psilocybin to learn what settings might dial up the awe of a psychedelic experience.”

Trip Or No Trip: Pharmas Are Taking Psychedelic Trials To Australia (Dec 13) ↗ Clinical Leader

Clinical Leader interviews Enveric Biosciences CEO, Joseph Tucker.