Effort to make ‘MDMA’ available for veterans suffering from PTSD symptoms

Dr. Rachel Yehuda, a trauma specialist extraordinaire, is at the forefront of groundbreaking research that might just make you question if we’re living in a sci-fi movie. She’s diving deep into the world of MDMA-assisted therapy, which, for those not in the know, is essentially giving veterans with PTSD a prescription for a clinically controlled rave. Her mission? To help these brave souls dance away their trauma with the assistance of what was once just a party drug. Dr. Yehuda’s work is shining a glittery spotlight on a potentially revolutionary treatment, bringing hope and a touch of sparkle to the field of mental health. If her research pans out, the future of PTSD treatment could look a lot more like Coachella with lab coats.



Reference: https://www.goodmorningamerica.com/gma3/video/effort-make-mdma-veterans-suffering-ptsd-symptoms-113812121


Published Date: None

Psychedelic Industry UK

Psychedelics are having their glow-up as the next big thing in therapy, offering groovy solutions for mental and physical health issues. Leading the charge in the UK is the Psychedelic Industry UK (PsyIndUK), the nation’s first official club for all things trippy and therapeutic. Strap in, because this industry is about to take us on an enlightening ride!



Reference: https://psyinduk.squarespace.com/


Published Date: None

John Krystal, MD: Exploring the Future of Ketamine and Psychedelic Treatment

Psychedelics in psychiatry are like a rollercoaster ride—promising highs and frustrating lows. Studies show potential for treating psychiatric disorders with psychedelics, but the FDA isn’t quite ready to party, especially with MDMA-assisted therapy for PTSD. Enter John Krystal, MD, the ketamine king, who’s all about its antidepressant magic. He co-founded Freedom Biosciences to supercharge ketamine’s benefits and cook up non-hallucinatory treatments, because who needs a trip when you just want to feel better?

Treatment-resistant depression (TRD) patients have a new hope: esketamine, which is basically ketamine’s cooler sibling. Forget the old-school electroconvulsive therapy (ECT) that’s harder to get than a unicorn sighting; esketamine is making waves in “Interventional Psychiatry,” boosting prescriptions and easing accessibility.

Psilocybin and MDMA are the underdogs waiting for FDA’s nod. Psilocybin might soon get the green light for major depression, and MDMA is eyeing PTSD with fingers crossed. Researchers are also diving into psychedelics for PTSD, migraines, and substance use disorders, all aiming for effective depression and TRD treatments. However, these psychedelic adventures can sometimes turn into a bad trip. MDMA, the empathetic party-goer of the bunch, is still gathering data to impress the FDA.

So, the world of psychedelics in psychiatry is full of hope, innovation, and a dash of trippy experiences, but with a cautious eye on safety and efficacy. Stay tuned for more twists and turns on this psychedelic ride!



Reference: https://www.psychiatrictimes.com/view/john-krystal-md-exploring-the-future-of-ketamine-and-psychedelic-treatment


Published Date: None

Psychedelics group wants to protect Portland users of mushrooms, other drugs from cops

Portland’s got a new mission: let the mushroom lovers be! Advocates are cooking up a 2026 ballot initiative to protect folks dabbling in non-toxic, non-addictive plant- or mushroom-based psychedelics from getting cuffed. The plan is to remind everyone that psychedelics have deep roots in healing and personal growth—sort of like how your grandma swears by her secret soup recipe. This initiative aims to make cops chill out about these substances and stop using city resources to bust users. It’s clear, though—no shroom-selling allowed! A Psychedelics Advisory Commission would also be born from this initiative, probably to keep things groovy and orderly. The Portland Psychedelic Society is gearing up to unveil this brainchild at a symposium and will kick off the signature hunt next year. So, get ready, Portland, the psychedelic revolution might just be coming to a ballot near you!



Reference: https://www.oregonlive.com/portland/2024/09/psychedelics-group-wants-to-protect-portland-users-of-mushrooms-other-drugs-from-cops.html


Published Date: 2024-09-18

After the Lykos debacle, what’s next for psychedelic therapies?

The FDA told Lykos Therapeutics to take a hike after rejecting their MDMA-based PTSD treatment, mainly because it wasn’t effective enough and had too many risks. This decision came after looking at data from the MAPP1 and MAPP2 trials, which studied 221 PTSD patients. Though the trials hit their main goals, the FDA committee wanted better risk details and suggested beefing up trial staff and data collection.

Lykos’s troubles didn’t end there: study blinding issues led to their MDMA being nixed, prompting the FDA to demand another Phase III trial. This blow resulted in Lykos cutting 75% of its workforce and several execs jumping ship. Despite this, experts still see potential in MDMA and psychedelics for therapy, with companies like Emyria, AWAKN, and Transcend in Phase II trials.

Amid these woes, MindMed’s CMO, Dr. Dan Karlin, is upbeat. He believes their approach, focusing on drug treatment without the trippy therapy sessions, will dodge the pitfalls that snared Lykos. MindMed’s MM-402 drug aims to keep things neutral and reliable, with Karlin eyeing FDA approval and noting increasing interest from veterans’ groups.

Meanwhile, Dr. Aron Tendler of GrayMatters Health is optimistic about teaming up with psychedelics to boost PTSD treatment, stressing the urgent need for new solutions due to the mental health crisis in the West. So, while Lykos is licking its wounds, the psychedelic therapy field is still buzzing with hope and potential breakthroughs.



Reference: https://www.pharmaceutical-technology.com/features/after-the-lykos-debacle-whats-next-for-psychedelic-therapies/


Published Date: 2024-09-16

Psychedelics can help the dying to deal with existential dread

Aldous Huxley, the legendary author of “Brave New World,” decided to go out with a bang—or rather, a trip—by requesting LSD on his deathbed on November 22, 1963. Talk about a far-out farewell! Huxley’s psychedelic send-off helped him embrace the great beyond with a serene smile. Groovy, right?

Turns out, Huxley might’ve been onto something. Research is now showing that psychedelics like magic mushrooms, LSD, and MDMA aren’t just party favors—they could actually be therapeutic lifesavers. Christopher Boehlke from University Hospital Basel is leading the charge, reviewing studies that indicate these mind-bending substances can significantly reduce anxiety, depression, and existential dread in terminally ill patients.

So, while Huxley took his final voyage on a wave of LSD, modern science is exploring how these trippy treatments could help others find peace when facing the end. Groovy and groundbreaking!



Reference: https://www.thetimes.com/uk/science/article/pyschedelics-can-help-the-dying-to-deal-with-existential-dread-jrqc80fzt


Published Date: None

Bad trip: How cul­ture con­flict and a need for cash near­ly broke Lykos

Endpoints subscribers can ditch their password post-it notes and opt for a one-time use magic link by entering their email. This abracadabra login method is quick, easy, and perfect for those with a chronic case of password amnesia. But be warned, the magic fizzles out after 24 hours, so don’t let your inbox become the Bermuda Triangle!



Reference: https://endpts.com/bad-trip-how-culture-conflict-and-a-need-for-cash-nearly-broke-lykos/


Published Date: None

Drug Science and University College London Collaboration: Advancing MDMA-Assisted Therapy

Drug Science and University College London (UCL) are joining forces to dive into the mysterious world of MDMA-assisted psychotherapy, aiming to decode the “psychotherapeutic component” that’s as elusive as a cat in a magician’s hat. The duo is set to start their magical journey in 2025, tinkering with therapeutic techniques to pinpoint what makes MDMA-assisted therapy tick.

Despite MDMA-assisted therapy showing up to clinical trials with shiny results and even getting a breakthrough therapy shoutout from the FDA, the FDA recently swiped left. Their reasons? A combo of regulation woes, issues with blinding, fears of MDMA being misused, therapist training headaches, and a big question mark over long-term benefits.

Drug Science, an independent UK charity that’s like Sherlock Holmes for unbiased drug research, is running experiments to see what happens when psychotherapists take MDMA. They’re hoping to crack the psychological code of MDMA and polish its therapeutic charm to meet those pesky regulatory standards.

UCL, the Hogwarts of universities with its vast and diverse student body, is bringing its multidisciplinary magic to the table. Together, they’re gearing up to turn MDMA-assisted therapy from a controversial cocktail into a finely-tuned potion of healing.

For more details, you can summon James Bunn (no invisibility cloak required).



Reference: https://www.drugscience.org.uk/uclmdma


Published Date: 2024-09-02

This study could be a game changer: issue 57

Issue 57 / Wednesday June 8, 2022

 

Hello and welcome (back) 👋

Here’s what’s in store for you in today’s issue:

🍄 Largest ketamine trial to date

🍄 Participate in a unique psilocybin study

🍄 A boom in government-funded trials

🍄 When you can expect psychedelic therapy to be legal

🍄 And more.

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2 years til medical legalization!

FDA approval of MDMA for PTSD and psilocybin for depression is anticipated within the next 24 months, according to a letter from the Department of Health and Human Services.

The department is also considering starting a federal task force dedicated to addressing complex issues surrounding psychedelics such as harm reduction and safety.

“Too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” the letter explains.

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First Phase 3 trial receives government funding

After receiving three ketamine therapy sessions in Awakn’s Phase 2 trial, patients with alcohol use disorder achieved an increase in abstinence from around 2% to 86%. This means they abstained from alcohol for an average of 162 of the 180 days following the treatment 👏

The results were so encouraging that the UK government granted the company CA$2.5M to fund Phase 3 of the trial.

The grant covers two-thirds of Awakn’s costs and marks the first time that a Phase 3 psychedelics trial has received government funding.

With 280 patients across 7 sites in the UK, it will be the largest ketamine-assisted therapy trial to date!

This study could be a game changer

A new government-funded study will see if psilocybin can ease depression without producing a psychedelic effect – and no, we aren’t talking about microdosing…

At Toronto’s Centre for Addiction and Mental Health, adults with treatment-resistant depression will receive a full dose of psilocybin + 12 hours of therapy. 

What makes this study unique is that some patients will also receive a serotonin blocker, which will block the psychedelic or hallucinogenic effects of the psilocybin.

If benefits can be delivered while avoiding the trip, this could open up psilocybin therapy to those who aren’t typically candidates for the treatment, as well as people who don’t want to hallucinate. 

Learn how you can participate in the study here 👇

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Compass Pathways (CMPS) initiated a Phase 2 psilocybin therapy trial for anorexia. It will be conducted on 60 subjects across 4 research sites.

Small Pharma (DMT) was granted a patent for its formulation of injectable DMT, marking its first US patent and ninth patent to date.

MindBio Therapeutics of Blackhawk Growth (BLR) received NZ$1.44M from the New Zealand government to study LSD microdosing for depression.

Braxia Scientific (BRAX) shared year-end financial reuslts includine $8.6M in cash and $1.49M in revenue, up 47.5% from the previous year. The company’s net loss was $12.1M compared to $88.8M the year prior.

You’re all caught up! See you next Wednesday 👋

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The DEA is no longer banning these drugs

In January, the DEA proposed to ban 5 psychedelic drugs (4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT) by classifying them as Schedule I substances.

After receiving significant pushback, the DEA has withdrawn the proposal.

Instead, the agency is requesting for the Department of Health and Human Services to conduct scientific and medical evaluations of the drugs to guide scheduling recommendations.

Health Canada’s verdict on MAPS

After sexual misconduct allegations arose from one of MAPS’ MDMA trials, Health Canada promised to review all upcoming MDMA trials that were previously approved.

Following the review, MAPS’ MDMA trial in Toronto has been suspended due to concern of patient safety. 

Some issued noted include “failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.”

However, MAPS’ MDMA trial in Montreal is allowed to proceed given that some “corrective and preventive” changes are made