👁️ The FDA Says NO to MDMA

Did you know uppers are famous for revving up the central nervous system, delivering that familiar surge of euphoria, energy, and heightened alertness?

Downers, are the opposite, mellow things out, soothing the system with relaxation, sedation, and reduced anxiety.

But psychedelics, the all-arounders, break the mold entirely. These mind-bending substances offer a unique blend of stimulation and relaxation, blurring the lines between physical and psychological effects.

They can awaken your senses and guide you into deep introspection, making them a powerful tool for grounding your mind and personal growth!

Gotta Blast 🚀:

• Fast-Tracking Psychedelic Research: New methods at UC Davis are speeding up how we understand the impact of psychedelics on brain neurons, potentially unlocking better treatments for mental health disorders.

• FDA’s MDMA Rejection: The FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for PTSD, citing the need for more rigorous studies. While it’s a blow, the push for psychedelic treatments continues.

• Kingston, Ontario Opens Canada’s First Psychedelic Treatment Center: Providence Care Hospital, in partnership with Queen’s University, has launched Canada’s first psychedelic treatment center, aiming to explore new therapies for mental health, substance abuse, and chronic pain.

Quote of the Week 📖:

CHANGING MINDS🧠

Fast-Tracking Psychedelic Research 🧬

Researchers at the University of California, Davis have developed a groundbreaking tool called CaST (Ca2+-activated Split-TurboID) that could revolutionize how we understand the effects of psychedelics on the brain.

Traditionally, tagging and tracking neurons involved in psychedelic experiences took hours, but CaST speeds this up to just 10-30 minutes.

This new method allows scientists to monitor the activity in neurons, especially in the brain’s prefrontal cortex, a region often affected by disorders like depression and PTSD. By tagging neurons activated by psychedelics, researchers hope to understand better how these substances promote brain plasticity and how they might be fine-tuned for therapeutic use.

The significance of this tool goes beyond speed; it opens the door to detailed, real-time analysis of how psychedelics influence brain chemistry without the need for invasive procedures.

With this advancement, the potential for creating targeted, non-hallucinogenic treatments that harness the benefits of psychedelics is closer than ever.

What do you think?

Is this a good alternative for those who may not be the right fit for traditional psychedelic medicines, but can still benefit from non-hallucinogenic solutions?

More in the Space 👁️

👁️ Research finds MDMA for PTSD is promising, but more studies are needed.

👁️ Kingston, Ontario opens Canada’s first psychedelic treatment center!

MOVING THE NEEDLE🪡

FDA’s MDMA Rejection: A Setback for Psychedelics, But Not the End 🫡

The FDA has delivered a significant blow to Lykos Therapeutics, rejecting its application for MDMA-assisted therapy for PTSD. In a Complete Response Letter (CRL), the agency requested an additional Phase 3 study, leaving Lykos to reassess its strategy. This decision, while disappointing, wasn’t entirely unexpected—industry insiders had been anticipating a negative outcome due to mounting concerns over study design flaws and the FDA’s advisory committee’s overwhelming ‘no’ vote.

The FDA’s CRL wasn’t just a simple rejection; it was a tough critique. Lykos now faces the daunting task of conducting another costly and time-consuming Phase 3 trial. The company has expressed its disappointment, noting that this decision delays much-needed relief for millions of PTSD sufferers who have seen no new treatment options for over two decades.

This decision also shines a light on the broader challenges faced by psychedelic-assisted therapies in gaining FDA approval. Psychedelic trials, like those for MDMA, push the boundaries of traditional clinical research, making them particularly susceptible to design flaws and placebo effects. As noted by experts, studying psychedelics is, in many ways, like studying the science of therapy itself—where set, setting, and patient expectations can profoundly influence outcomes.

Looking ahead, Lykos and others in the psychedelic space will need to rethink their trial designs, possibly moving away from traditional placebo-controlled studies toward more complex designs that better account for the unique nature of psychedelic experiences.

While this FDA rejection is a significant setback, it’s not the end of the road for MDMA-assisted therapy. The focus now shifts to whether Lykos can meet the FDA’s demands and what this decision means for the future of psychedelic medicine.

More in the Space 👁️

👁️ Massachusetts governor approves psychedelics working group for veterans' therapy

👁️ Timothy Leary’s historic LSD mansion listed for $65 million.

COMMUNITY PULSE 🌐

_{LET’S LEARN}

Counterculture’s Psychedelic High 🫨

Imagine a time when music, culture, and mind-altering substances collided to create a seismic shift in society. The 1960s were a whirlwind of psychedelic exploration, with iconic bands like The Beatles and Jimi Hendrix leading the charge. Their music, fueled by LSD and psilocybin, not only defined an era but also sparked a movement that would eventually face a harsh crackdown. But what if the artistic excess of that time hadn’t overshadowed the scientific potential of psychedelics?

This is the story of how a countercultural revolution both ignited and derailed a promising chapter in mental health research—and what it means for the future as we rediscover the therapeutic power of these substances today.

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Taking a “Trip” Down Memory Lane

Neuroscientist Describes a Mushroom Experience

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Psychedelic Practitioner Fundamentals: Foundations for Ethical, Trauma-Informed, and Client-Centered Care

📅Dates: August 27th - September 7th

Online

This workshop series is a vital educational opportunity for practitioners navigating the complex responsibilities and ethical challenges in the growing field of psychedelic therapy. 🌿 

This six-part series, hosted by the Synthesis Institute, offers essential training from leading experts, ensuring that both established and aspiring practitioners are equipped with the knowledge and tools to provide safe, ethical, and effective psychedelic care. Don't miss out on this opportunity to deepen your understanding and enhance your practice in this transformative field.

This is an event you don’t want to miss!

Psychedelics in the Media

📅Dates: Now until August 18th, 2024

Vote Now!

Support the "Psychedelics in the Media" panel at SXSW! 🌟 This session will dive into the impact of mainstream media on public perception, policy, and the future of psychedelics. From debunking fear-mongering myths to exploring the role of design and branding, the panel will discuss how we can shape a positive and realistic narrative around psychedelics. Featuring insights from the amazing Carly Dutch-Greene, Alexandra Plesner, Cesar Marin, and Dennis Walker, this is a must-vote panel for anyone passionate about the future of psychedelics!

BEFORE WE GO😢

Thank you for reading and being a part of this psychedelic journey! 🍄

👁️ Are you a psychedelic therapist/coach, retreat center, or brand looking to elevate your content? PSYCHSPACE Creations is here to help. Book a consultation call with us today and let’s bring your vision to life!

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