Actively Recruiting
LSD to Improve Cluster Headache Impact Trial
Led by Radboud University Medical Center · Updated on 2025-04-15
65
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 explore cost-effectiveness of treatment with LSD in cCH. * To evaluate the efficacy of LSD on health-related quality of life.
CONDITIONS
Official Title
LSD to Improve Cluster Headache Impact Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic cluster headache according to the International Classification of Headache Disorders version 3 (ICHD-3)
- Stable weekly attack frequency in the 4 weeks before screening, averaging at least 8 attacks per week within a 40% range
- At randomization, an average of at least 8 attacks per week with no more than two consecutive days without attacks during baseline
You will not qualify if you...
- Use of excluded treatments at screening or during the study (including lithium, unstable prophylactics, steroids or GON block within 2 months, sphenopalatine block, neurostimulation changes within 3 months, or botulinum toxin within 3 months)
- Use of LSD derivatives, psilocybin, ketamine, or cannabis within 3 months before screening and during the study
- Lifetime or family history of psychotic or bipolar disorder, suicidal intention or attempts
- Score of 6 or more on the PQ-16 test indicating susceptibility to psychosis
- Current abuse of alcohol or recreational drugs
- Lifetime history of cardiac valvular disease
- History or evidence of cognitive disorder at screening
- Positive urine drug test at screening
- For females: pregnancy, breastfeeding, or not using acceptable contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Leiden University Medical Center (LUMC)
Leiden, Netherlands
Actively Recruiting
2
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Netherlands
Actively Recruiting
Research Team
J
Julia Jansen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here