LSD to Improve Cluster Headache Impact Trial

This double-blind, placebo-controlled trial (n=65) will assess the efficacy and safety of LSD (25μg) every 3 days for 3 weeks versus placebo in treating chronic cluster headaches (CCH).

Conducted by Radboud University Medical Center, the study aims to address the considerable unmet need for effective treatments for cCH. The primary objective is to evaluate the efficacy of LSD in reducing cluster headache frequency, with additional objectives including safety evaluation, exploration of exposure-response relationship, assessment of hypothalamic functional connectivity using rsMRI, exploration of cost-effectiveness, and evaluation of health-related quality of life.

Participants will be between 16 to 75 years old and must meet inclusion criteria such as stable weekly attack frequency. The study is set to begin in January 2024 and estimated to complete by August 2025. If positive, this study could lead to LSD being further studied for routine clinical use in treating cCH.

Topic Headache Disorders Microdosing
Compound LSD Placebo
Country Netherlands
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2024
End date 31 August 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 64
Sex All
Age 16- 75
Therapy No

Trial Details

This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: - To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. - To explore the exposure-response relationship of 25μg LSD in cCH. - To assess the effect of treatment with 25μg LSD on hypothalamic functional connectivity in patients with cCH, using resting state functional magnetic resonance imaging (rsMRI). - To explore cost-effectiveness of treatment with LSD in cCH. - To evaluate the efficacy of LSD on health-related quality of life.

NCT Number NCT05477459

Sponsors & Collaborators

Radboud University
This company page is linked to research but doesn't have a full profile yet.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.