Today’s newsletter takes about 5 minutes to read—so if you’ve only got 60 seconds, here’s what you need to know:

👉 From raves to clinical studies, MDMA has had quite a journey in the public eye…

This issue will give you the context, tools, and knowledge to decide what’s actually worth exploring in the MDMA domain…

Keep an open mind and read on!

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🍄 In this episode, our discussion with Brom explores a timely question at the intersection of medicine and markets: Can psychedelics become an engine for economic growth? Together, they unpack why investors are paying attention and how mission-driven capital might accelerate access to healing, discussing Empath Ventures as a case study.

🫶 They also discuss the realities of building psychedelic start-ups inside today’s healthcare system, the metrics investors look for when backing founders, and the balance between profit and public benefit. Brom specifically shares his vision for a future in which safe, legal plant-medicine therapies coexist with traditional care and create new jobs, clinics, and research paths along the way.

🎧 Whether you’re fascinated by conscious capitalism, curious about the emerging psychedelic industry, or just eager to imagine a world where healing and business can align, this conversation offers grounded insight and bold inspiration for dreamers and doers alike…

MDMA-assisted therapy pairs carefully-dosed MDMA (Ecstasy) with talk therapy (psychotherapy) in a clinically supervised setting.

Early studies and underground tales suggested that it may help with an array of mental health conditions, including social anxiety in autistic adults, end-of-life distress, and alcohol use disorder…

And while the early signals are promising, researchers (and the FDA) still need larger, more rigorous trials to confirm safety and effectiveness before changing its legal status and suggested uses.

A randomized, double-blind pilot study back in 2018 gave autistic adults two 8-hour therapy sessions with either MDMA (75–125 mg) or a placebo, plus integration sessions.

Interestingly, the MDMA group showed greater reductions on the Liebowitz Social Anxiety Scale (LSAS) that lasted at least 6 months after the trial, highlighting potential long-term changes in the brain for these individuals.

In a small, double-blind pilot published in 2020, people with life-threatening illnesses received two MDMA-assisted psychotherapy sessions (125 mg) or a placebo.

The MDMA group had a larger drop in trait anxiety at the primary endpoint (p≈ 0.056) compared to the placebo group, and the treatment was generally well-tolerated for those who took it.

Open-label follow-up suggested longer-term gains—signals that warrant bigger studies.

A 2021 open-label feasibility study in 14 post-detox participants used two MDMA sessions (187.5 mg each) within structured therapy.

The treatments were well-tolerated, and average weekly drinking fell from ~130.6 units pre-detox to ~18.7 units at 9 months. Early data only—but compelling enough to justify controlled trials.

Two randomized, placebo-controlled Phase 3 trials in Nature Medicine (2021, 2023) found that three MDMA-assisted therapy sessions produced larger reductions in clinician-rated PTSD severity (CAPS-5) than placebo with identical therapy, which was an exponential improvement compared to traditional forms of PTSD treatment.

Even more convincing, in the confirmatory trials, 86.5% had a clinically meaningful benefit, and 71.2% no longer met PTSD criteria at study end…

Once again, treatment was generally well tolerated by most individuals and resulted in improved overall functioning, as measured by the Sheehan Disability Scale (SDS) functional impairment evaluation.

Unfortunately, in 2024, an FDA advisory panel voted that evidence for MDMA-assisted therapy in PTSD was insufficient (9–2 on efficacy; 10–1 that benefits didn’t outweigh risks).

The agency later issued a Complete Response Letter requesting additional work to be done, and in the aftermath, Lykos Therapeutics downsized while planning its next steps.

Publication of the CRL in 2025 clarified issues like blinding, durability, and user biases, which future trials must address. Many are hopeful these new trials will be stronger and confirm what previous studies have already shown.

Studies across the board investigating MDMA-assisted therapy continue to provide meaningful improvements in patients’ symptoms and overall quality of life, but it is evident that there are clear limits to these studies that warrant further investigation (small samples, study design challenges, etc).

Larger randomized studies with long-term follow-up and robust safety monitoring will determine where MDMA-assisted therapy truly fits in mental health care…

While we’re optimistic the research will eventually provide enough data to overturn these rulings, we have to wait for the studies to show us the true outcomes.

Until then, it’s best to use caution and keep up to date on the latest guidelines.

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"It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so." - Mark Twain

Just when you think you know… Life has a way of completely challenging everything.

And that’s the psychedelic space in a nutshell, isn’t it?!

🚦 If this week’s issue blew your mind 🤯 , here’s what you can do to keep this train moving:

At Webdelics, we’re here to make plant-medicine and psychedelic education clear, evidence-based, and actionable, so you can make informed choices with fewer regrets…

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