As the principal investigator of the first and only IND for combined therapy within the United States, Dr. Andrew Schindler has steered a truly pioneering clinical trial. This is the first randomized, double-blind, and placebo-controlled study investigating the efficacy of psilocybin, a naturally occurring psychedelic compound, for cluster headache treatment. The plea took place a week before the trial was set to begin in late 2022. The study included patients with a chronic pattern of cluster headaches, who were given psilocybin or a placebo over eight weeks. This groundbreaking research has the potential to offer new hope and relief for patients whose lives are too often dominated by the debilitating effects of chronic pain.
Cluster headaches affect only 0.1% of the global population. They’re sometimes considered the worst pain on the planet. The mood disorder can have tragic effects, including a 50 times higher risk of suicide. Dr. Schindler’s research has been showing promising results, with four out of five participants going into remission after receiving psilocybin. In a follow-up long-term extension study, all ten of the returning patients received psilocybin, further cementing the promise of this treatment.
Despite these advances, Schindler’s work is under serious threat from funding cuts that were instituted during the Trump administration. Previously, the National Institutes of Health (NIH) has consistently reduced appropriations for health and education research. This ill-informed decision is having serious consequences for laboratories and universities across the country. Schindler’s research team is now under tremendous pressure. They’re doing so while sailing through treacherous waters where billions of dollars in funding hang in the balance.
The Impact of Psilocybin on Patients
In the first study, participants took psilocybin as well as an inert placebo three times within a five-day period. Each patient’s progress was carefully monitored for as many as eight weeks. Schindler’s randomized controlled trial, released in November 2022, reaffirmed the preliminary efficacy of psilocybin for the acute treatment of cluster headache attacks. Those results have made waves both in the U.S. and internationally. In the meantime, a small Danish study released in January 2024 corroborates Schindler’s findings.
Patients such as Peter have been vocal about their nightmarish experiences with cluster headaches. “I actually told the doctors after my fourth week of coming back, like, ‘I’m ready to fucking kill myself here. I need someone to take some ownership here, because none of you, none of what you’re doing is helping,’” he expressed during an interview. This longing epitomizes the despair experienced by all of those afflicted with this disease.
Another patient described the excruciating pain associated with cluster headaches, stating, “Mid-30s female. Pain is … worse than childbirth or tooth pain … it’s like my head has exploded into an electric storm.” Victims’ accounts like these continue to demonstrate an acute unmet need for effective, safe treatment options and stress the importance of Schindler’s research and studies like it.
Funding Challenges and Advocacy
The financial hurdles preventing researchers like Schindler from doing their work have caused an outcry among the scientific community. “In the last 25 years, the NIH has contributed something like less than $20 million to anything even remotely related to cluster headache, which is crazy considering that … it is, as we now know, the single most painful condition on the planet,” remarked Dr. Gottschalk, an advocate for increased funding in this area.
Schindler and his team are currently working to lobby legislators to get them to appropriate more funding for headache research. Most recently, they led the charge in asking for a new $30 million line in NIH funding to establish Headache Centers of Excellence throughout the United States. These centers will conduct cutting-edge research for patients enduring painful cluster headaches. They’ll be looking into cutting edge treatment for people with other complex headache disorders too.
Protesters outside the legislative buildings have raised the level of their advocacy and demands for increased funding. They speak from experience and speak from the heart, chanting “Kill the cuts save lives.” This new grassroots movement highlights the important new call to action — the need for advanced research that will save and improve lives.
The Path Forward
As a researcher, Dr. Schindler is still focused on following the therapeutic targets that explain how psilocybin helps patients with cluster headaches. He knows that kind of comprehension will probably take the rest of his career — an expectation he’s had since he started down these paths. We don’t need amateurs,” stressed one early-career scientist, making the case for a more robust research pipeline.
Schindler’s constant and uncompromising pursuit of intellectual understanding follows from his desire to understand the disorder’s atypical presentation and severity. He continues to make strides in his research achievements. His mission is to bring relief to the millions of people who suffer from cluster headaches.
Community support has been vital in creating a comforting atmosphere for patients impacted by this condition. Sophia Lorenzo noted, “Knowing that other people are going through it too makes me feel less alone. Like I’m not crazy. That this will pass. The community has really saved me in more ways than one.”
