LSD to Improve Cluster Headache Impact Trial
Efficacy and Safety of Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache: a Randomized Placebo-controlled Study
Radboud University Medical Center
65 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- CCH according to the International Classification of Headache Disorders version 3 (ICHD-3)
- At screening: stable weekly attack frequency in the 4 weeks prior to screening (assessed retrospectively), averaging at least 8 per week and each week within a 40% window around the average
- At randomization: average of at least 8 attacks per week and no absence of attacks on more than two consecutive days during baseline
Exclusion Criteria9
- Use of excluded concomitant treatment at screening (lithium; other prophylactics if not on a stable dose for less than one month; steroids/GON block within 2 months before screening; sphenopalatinum block, neurostimulation (changed setting within 3 months before screening) or botulinum toxin within 3 months before screening) and during the double-blind phase
- Use of LSD(-derivatives) (other than investigational drug), psilocybin, ketamine or cannabis within 3 months prior to screening and throughout the study
- Lifetime and/or family history (first degree relatives) of psychotic or bipolar disorder, suicidal intention or attempt
- A score of 6 or more on the 'Ervaringenlijst' (PQ-16) to exclude subclinical susceptibility to psychosis
- Actual abuse of alcohol and/or recreational drugs
- Lifetime history of cardiac valvular disease
- History or evidence of cognitive disorder at screening
- Positive urine drug screen at screening
- Females: Pregnancy, lactation, no acceptable contraceptive use
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Interventions
LSD tartrate equivalent to 25 microgram LSD base
Placebo with equal appearance
Locations(2)
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NCT05477459