Actively Recruiting
Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-07
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 to 75 years
- Chronic cluster headache according to International Headache Society criteria OR episodic cluster headache with predictable episodes lasting about 2 months and expected ongoing cluster period for at least one month beyond inclusion
- Attacks respond to oxygen
- Sufficient understanding of study procedures and risks
- Willingness to follow study procedures and sign consent
- Willing to abstain from preventive and abortive medications except oxygen before and after treatment to avoid drug interactions
- Willing to refrain from psychiatric medications during experimental sessions, including discontinuation of antidepressants, lithium, or anxiolytics if on a fixed regimen
- Agree to avoid psychoactive drugs and caffeine within 24 hours of each treatment session
- Agree not to use nicotine at least 2 hours before and 6 hours after each dose
- Agree to avoid alcohol at least 1 day before each treatment session
- Willing to not drive or operate machines within 24 hours after treatment
You will not qualify if you...
- Other headache types including migraine, paroxysmal hemicranias, SUNCT or SUNA
- Women who are pregnant, nursing, or of child-bearing potential not using effective birth control
- Past or present primary psychotic disorder or first-degree relative with psychotic disorder
- Past or present bipolar disorder
- Current substance use disorder except nicotine
- Severe cardiovascular disease or untreated hypertension
- Severe liver disease or impaired kidney function
- Weight less than 45 kg
- Participation in another clinical trial within last 30 days
- Use of high-dose steroids over long periods
- Use of immunomodulatory agents in past 2 weeks
- Use of serotonergic antiemetics in past 2 weeks
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive either lysergic acid diethylamide (LSD) or placebo, administered orally 3 times within 3 weeks in a crossover design.
3 treatment visits within 3 weeks
Duration - 8 weeks after each treatment pulse
Participants are monitored for effects and safety for approximately 8 weeks after each treatment pulse, including assessments of headache frequency, intensity, and quality of life.
Regular follow-up visits during 8-week post-treatment periods
Trial Site Locations
Total: 1 location
1
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Matthias Liechti, Prof.
Y
Yasmin Schmid, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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