Study of Oral Lysergic Acid Diethylamide LSD to Treat Cluster Headache in Adults Aged 25 to 75 Randomized, Double-Blind, Placebo-Controlled Phase II Trial

What this Trial Is About

Researchers are studying the use of lysergic acid diethylamide LSD, a serotonergic psychedelic, as a potential treatment for cluster headache CH. This condition, known for causing severe pain and disability, currently has limited effective treatments. The study is a randomized, double-blind, placebo-controlled Phase II trial involving patients aged 25 to 75 with chronic or episodic CH that respond to oxygen and have predictable attack periods lasting about two months. Participants receive an oral pulse regimen of LSD 100 micrograms, three times over three weeks or placebo in a cross-over design where each participant receives both treatments in different phases. The study aims to compare the effects of LSD versus placebo on the frequency and intensity of CH attacks. The trial includes a washout period between treatments to avoid drug interactions, and participants abstain from certain medications and substances during the experimental sessions. During the study, participants keep a standardized headache diary to track changes in attack frequency and intensity. Researchers also assess a variety of secondary outcomes including attack duration, time to first attack after treatment, quality of life, and psychological symptoms using questionnaires. Safety is monitored through vital signs and adverse event reporting over approximately one year. The primary outcome focuses on changes in cluster headache attacks over eight weeks before and after the treatment regimen.

Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache