☁️🍄 Issue No. 012: Meet Molly

Welcome back Headliners, and happy early Bicycle Day. 80 years ago, Swiss chemist Albert Hofmann ingested 250mg of LSD and embarked on the world’s first acid trip — on a bike, no less. 🚲

The substance we’ll be exploring today? Not quite two-wheeled, but it’ll still get you rolling.

MEET MOLLY

MDMA therapy may be coming sooner than you think. 

ON THE MAP(S)

Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is one of the most influential psychedelics organizations in the world. For decades, it has been fundraising, researching, and conducting trials for MDMA-assisted therapy.

In the last few years, MAPS has made significant headway legitimizing MDMA as medicine, specifically as a treatment for PTSD: 

• In May 2021, researchers reported that 88% of participants responded to treatment in its first Phase 3 trial.

• In late 2022, MAPS completed its second Phase 3 trial and announced positive findings; full details will be published later this year.

• This April, the company announced that results from its prior studies were sustained — participants showed lasting improvements six months after dosing. 

Of note, these Phase 3 trials are the final step in drug testing before approval, and the completion of these studies were the first of their kind for psychedelic therapy. 

Next up, researchers plan on submitting a new drug application in Q3 2023. MAPS founder Rick Doblin says he believes it could be approved as soon as Q2 of 2024. 

In other words, MDMA is the clear frontrunner in the psychedelic “race” for legalization, which could be in just over a year. 

A BRIEF HISTORY

Molly, ecstasy, E — MDMA goes by many names, but when psychotherapists first started experimenting with it in the 1980s, some called it “Adam” for its apparent ability to help patients return to a state of innocence.

Decades ago, MDMA made its way into therapy circles via American chemist Alexander “Sasha” Shulgin, who introduced the substance to psychotherapist Leo Zeff. Zeff was so blown away by its potential that he came out of retirement to study the drug.

But the substance was also catching on in other circles — across the country, molly was fueling the rave scene, becoming the drug du jour. Soon enough, it had grown so popular that the government cracked down on the substance. The DEA criminalized MDMA in 1985, classifying it as a Schedule I drug.

Since then, MDMA has been at the center of anti-drug campaigns, from outsized myths of its neurotoxicity to claims it will give you Swiss-cheese brain. While these “findings” have since been retracted, they’ve had a lasting impact on its reputation. 

MDMA-KEOVER

But with legalization on the horizon, MDMA is turning over a new leaf. 

How it works: Unlike classic psychedelics or dissociatives, MDMA is an indirect serotonergic agonist; it binds to and blocks serotonin receptors, increasing the amount of serotonin in the brain.

It also triggers the release of neurotransmitters like dopamine and norepinephrine, leading to pro-social feelings of euphoria and closeness to others.

These characteristics make it a powerful tool for those with PTSD. Fostering trust and connection, MDMA can dampen fear and stress responses, helping people recollect and discuss intense experiences without becoming overwhelmed.

Often, patients with PTSD don’t have the capacity to recall traumatic memories without getting hijacked by fight-or-flight survival responses. You can’t work with experiences you can’t access; MDMA can make things workable. 

This process, known as memory reconsolidation, is increasingly seen as the core mechanism in healing. 

MOLLY MONOPOLY

Now, with any drug, especially one so potent, there are pressing ethical questions. 

On the cost/access front, there are concerns that MAPS would have a major monopoly on the treatment if approved. The estimated price tag for the full protocol? A whopping $15K. 

That brings up worries that people will go underground for self-treatment. And black market ecstasy is notorious for being mixed with adulterants, including dangerous opioids like fentanyl. 

Meanwhile, MAPS seems concerningly eager to drive its vision forward at all costs. The company has come under fire for everything from manipulating veterans to sexual abuse; participants who actually felt worse after trials said they were somehow counted as success stories. One noted that their experience felt like:

Indeed, the treatment itself isn’t without risks. While MDMA tends to be more “positively” valenced than substances like psilocybin or LSD, there are real dangers of destabilization.

Punchline: A powerful prosocial connector, MDMA’s potential is enormous. Beyond PTSD, from couples therapy to general psychotherapy, millions could benefit. 

But companies must practice patience and caution. When psychedelic zeal overtakes clinical safety, it can perpetuate the very trauma they’re trying to heal.

QUICK HITS

• Bedspace. The US needs at least 75K more psychiatric beds to meet estimated behavioral health needs.  

• Dark side of the shroom. New study details long-term negative psychological responses to psychedelics. 

• Crypto care. Deepak Chopra and Shira Lazar to launch The JOMO Effect, a mental health-focused NFT collection. 

• Against their will. Newly proposed CA bill would make it easier to involuntarily detain the mentally ill.

• Good faith. Magic mushroom church Zide Door to open new location in SF. [Re-read Issue No. 005: Psychedelic Churches]

NEWS & TRENDS

1) Mental Health VC Directory

One of our main goals here at Headlines is to act as a hub of connection for mental health operators everywhere. To further this vision, we’ve partnered with PsyMed Ventures to put together a list of 100+ investors active in the mental health space.

Access it here.

2) Creative license

While ketamine clinics shutter left and right, Numinus Wellness seems to be doing just the opposite. The company just launched Numinus Network, a new clinic licensing model. 

Under the program, independent practitioners will be able to open, own, and operate a clinic under the Numinus brand. The network is supported by a key partnership with real estate investment company Healing CREI, who will provide a “turn-key clinic solution” to licensees. The announcement comes, notably, after Numinus reported a sizable 580% YoY revenue jump this Q2. Making moves.

DEALS & DEBUTS

🌷 Spring Health, a B2B behavioral health platform, notched $71M to hit a $2.5B valuation. The organization works with employers and health plans to offer digital support, therapy, coaching, and more.→ source

🔁 Recuro Health, a virtual care company, closed a $47M Series B led by ARCH Venture Partners. The funding will go towards scaling its Digital Medical Home, diagnostic-enabled at-home care for primary and behavioral health. → source

🧠 Clearmind Medicine, a psychedelic pharmaceutical company, closed a $3.5M public offering. The company plans on creating treatments for alcohol use disorder.→ source

🍎 Oshi Health, a virtual gastrointestinal care startup, raised a $30M Series B led by Koch Disruptive Technologies. The company integrates behavioral care into its treatment, examining how trauma impacts the gut, along with nutritional advice and medication. → source

🌱 TARA Mind, a psychedelic therapy platform, emerged from stealth with $3M in pre-seed funding from Red Cell Partners. The company aims to address the industry’s systemic issues of access and affordability.→ source

🩺 Nolea Health, a mental health recruitment platform, emerged from stealth with £1M ($1.2M). The London-based startup aims to address mental health clinician staffing shortages for healthcare providers.→ source

🌿 British American Tobacco is investing $10M in a joint venture between Charlotte’s Web Holdings and AJNA BioSciences PBC. The partnership aims to develop a novel botanical drug to target a neurological condition. → source

🏥 Revitalist Lifestyle and Wellness, a ketamine clinic operator, entered a joint-venture agreement with GCM Partners to offer new treatment locations in Chicago and Florida. → source

🎧 The Ad Council teamed up with Amazon to launch an interactive music-based mental health campaign. The digital experience is meant to help parents tap into their teen’s emotional well-being via sound. → source

🍄 Cybin, a psychedelic biopharmaceutical company, announced EMBARK Open Access, a free online course for psychedelic facilitator training.→ source

🛒 Walmart launched a new Workplace Mental Health course to teach Walmart leaders and managers how to help someone struggling with behavioral health issues. It will be facilitated by clinicians from workforce mental health platform Lyra Health. → source

🌎 ReKlame Health, a BIPOC mental healthcare provider, is expanding its services to your doorstep. The startup is rolling out an in-home program for addiction medicine care in NYC.→ source

WHAT I’M READING

• Science is a strong-link problem. How can we optimize research around mental health, psychedelics, and more? One helpful framework: understanding whether you’re dealing with strong- or weak-link problems. → Experimental History

• Dissecting spiritual awakenings. The intersection between spirituality and psychology is sorely underresearched. Researchers at the Berkeley Alembic want to change that. → Sasha’s Newsletter

• Digital snake oil. As digital mental health tech proliferates, we’re in dire need of governance and accountability. Who’s working on differentiating the useful from the snake oil? → STAT News

You’re all caught up! If you haven’t subscribed to Headlines yet, join us below.

In the meantime, hope you’re having a nice time out there as the weather gets warmer. I’ve been learning/practicing some acroyoga and having lots of fun with it. (Also happens to be a great excuse to get outside and touch grass). 

Until then,

-Mel