Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Background: After no official research in humans in the last 40 years, research and
therapeutic uses of the serotonergic psychedelic lysergic acid diethylamide (LSD) are now
re-recognized and include its use in brain research, alcoholism, anxiety associated with
terminal illness, and treatment of headache disorders. Specifically, LSD has been reported to
abort attacks, to decrease frequency and intensity of attacks, and to induce remission in
patients suffering from cluster headache (CH).
Objective: To investigate the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three
weeks) in patients suffering from CH compared with placebo.
Design: Double-blind, randomized, placebo-controlled two-phase cross-over study design.
Participants: 30 patients aged ≥ 25 and ≤ 75 years with chronic or episodic CH with
predictable periods lasting approximately 2 months and attacks responding to oxygen.
Main outcome measures: Changes in frequency and intensity of CH attacks assessed with a
standardized headache diary Significance: CH is often rated as the most painful of all
primary headaches, which not only causes significant disability, but is also associated with
enormous personal, economic, and psychiatric burden. At the moment, there is no specific
treatment available for CH, but serotonergic compounds represent an important drug class,
especially in the abortive management of cluster attacks. However, there is a need for new
treatment approaches, as CH is also often insufficiently managed with available medication.
This study will evaluate the potential benefit and safety of a treatment with LSD for
patients with CH.