👁️ What’s Next for MDMA Treatment?

Did you know psychedelics have been integral to human culture for millennia, used in rituals and ceremonies to provide profound spiritual and psychological insights?

One of the earliest known uses of these substances is depicted in cave paintings in the Tassili-n-Ajjer region of the Sahara Desert, Algeria. These murals, estimated to be 7,000 to 9,000 years old, feature a bee-headed figure known as the 'mushroom shaman' with mushrooms, identified as Psilocybe mairei, sprouting from his body.

Terence McKenna, in "Food of the Gods," believes that these paintings illustrate an ancient and deep connection between humans and hallucinogens, potentially influencing the development of human consciousness and culture.

Gotta Blast 🚀:

• MAPS Faces Setbacks: FDA panel raises concerns and votes against MDMA therapy for PTSD.

• FDA Warning: Microdosing chocolate bars linked to hospitalizations—find out why.

• Mindbloom's Ketamine Study: Largest study shows at-home ketamine therapy is safe and effective.

Quote of the Week 📖:

CHANGING MINDS 🧠

MAPS Faces Setbacks in FDA Review for MDMA-Assisted Therapy 😓

It's been a challenging time for the psychedelic community.

On June 4, 2024, the FDA's Psychopharmacologic Drugs Advisory Committee reviewed Lykos Therapeutics' New Drug Application (NDA) for MDMA-assisted therapy for PTSD. Despite diligent efforts by both the FDA and Lykos, the committee raised significant concerns and voted against approval, highlighting issues with data validity, potential for abuse, and patient safety.

The Citizens Commission on Human Rights International (CCHR) welcomed this decision, citing risks such as increased heart rate, psychiatric symptoms, and documented misconduct in clinical trials.

Additionally, the Institute for Clinical and Economic Review (ICER) and other panel members expressed worries about placebo bias, ethical concerns, and the lack of diversity among trial participants.

Kim Witczak, the FDA panel’s consumer representative, stated, "I can't in good conscience support something where this many harms are being reported."

Despite these setbacks, Lykos Therapeutics remains committed to addressing these concerns:

• Data Validity: Improving data collection on subjective effects like euphoria and mood.

• Safety Measures: Implementing rigorous training for therapists to prevent misconduct.

• Diversity: Increasing BIPOC participation in clinical trials.

CEO Amy Emerson acknowledged the critical need for new PTSD treatments and emphasized continued collaboration with the FDA to resolve outstanding issues.

As we face these hurdles, MAPS remains dedicated to advancing psychedelic research and ensuring the highest standards of safety and efficacy.

What do you think is the most critical area that needs improvement for MDMA-assisted therapy to gain approval? Share your thoughts with us!

More in the Space 👁️

👁️ Arizona is on the brink of legalizing psilocybin service centers—see what’s next for this groundbreaking legislation.

👁️ Oregon's psilocybin program faces unexpected challenges one year in—find out what’s happening behind the scenes.

👁️ FDA issues urgent warning after microdosing chocolate bars send six people to the hospital—learn more about the risks.

MOVING THE NEEDLE 🪡

Mindbloom's Groundbreaking Study on At-Home Ketamine Therapy 🔬

Mindbloom has just released the largest study to date on ketamine therapy, involving a whopping 11,441 clients. This comprehensive research highlights the effectiveness and safety of guided at-home ketamine therapy for treating depression and anxiety.

The study found that 62% of clients reported clinically significant improvements in their depression or anxiety, with 28% achieving full remission.

Even more impressive, significant symptom improvements were noted after just four sessions.

Safety was also a key focus, with fewer than 5% of clients reporting adverse effects, primarily neurological or psychiatric in nature, underscoring the importance of ongoing behavioral support.

"Millions of Americans are suffering from mental illness and haven’t been helped by traditional treatments. This study confirms that at-home ketamine therapy can be an effective and fast-acting treatment for depression and anxiety," said Dr. Leonardo Vando, co-author and Mindbloom Medical Director.

Key Findings:

• Rapid Results: Significant improvements after only four sessions.

• Sustained Benefits: 84% of those who saw improvements maintained or further recovered in a second round of treatment.

• Safety: Fewer than 5% reported adverse effects.

Mindbloom's at-home model has been crucial in making this therapy accessible and affordable. Founder and CEO Dylan Beynon highlights that telehealth allows clients to heal from the comfort of their homes, overcoming barriers like cost, provider availability, and stigma.

The study also leveraged artificial intelligence and machine learning to predict which clients are most likely to respond to treatment, providing valuable insights for clinicians.

More in the Space 👁️

👁️ Older adults who have used psychedelics show better cognitive function and fewer depressive symptoms—discover the surprising findings from new research.

COMMUNITY PULSE 🌐

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Psychedelics Design Conference

📅 Dates: Thursday, July 11 · 11am - 4pm CDT

Online

Our amazing friends at Psychedelics Design are hosting an online event to spark transformational conversations around the intersection of psychedelics, creativity, and design! Some of the greatest minds in the psychedelic industry will be speaking on a variety of topics such as brand, media, and research. This is an event you don’t want to miss!

Zendo SIT (Sitting and Integration Training)

📅 Dates: July 8, July 15, July 22, and July 29, Mondays @ 5pm – 7:30pm

Online

Learn the core principles of psychedelic harm reduction, the role of the sitter, effective strategies for handling challenging experiences, and more! Whether you are new to psychedelic peer support or aiming to enhance your existing skills, this course is tailored to meet your needs.

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