I understand it seems hard to believe! And yes, Iām motivated to support /ā advocate for RCTs and Iām developing various ideas with some collaborators (not just involving psychedelics). I agree that more data published in peer-reviewed journals is very much needed.
The documented barriers to psychedelic cluster headache research reveal systemic failures across every institution that might otherwise advance treatment. Schedule I classification adds years to research timelines. NIH has invested almost nothing in cluster headache specifically. Pharmaceutical companies see no return in treatments requiring only three doses annually. Academic institutions impose unique scrutiny on psychedelic protocols. Patient recruitment struggles with rarity, episodic presentation, and placebo reluctance.
The BOL-148 story crystallizes the tragedy: a non-hallucinogenic compound showed unprecedented efficacy in 2010, yet required 13 years to enter Phase 1 trials because it fell between orphan drug and commercial viability. As Bob Wold observed: āYou canāt introduce transformative medicine into a broken healthcare system.ā The gap between patient discovery in 1998 and the current state of researchāwith perhaps one dedicated US researcher and trials measured in dozens of participantsārepresents what Halpern called āa process that has begun 40 years too late.ā
I understand it seems hard to believe! And yes, Iām motivated to support /ā advocate for RCTs and Iām developing various ideas with some collaborators (not just involving psychedelics). I agree that more data published in peer-reviewed journals is very much needed.
I still genuinely believe that the funding and legal barriers are very difficult to overcome (plus other barriers). A good resource on this topic is the book Psychedelic Outlaws (describing the history of psychedelic use and research for CH). This deep research by Claude may also provide useful context: Why psychedelic research for cluster headaches has stalled despite decades of patient evidence. It concludes: