Cluster HeadachePhase 2LCHNCT03781128
Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
A Phase 2 study testing Lysergic Acid Diethylamide in people with Cluster Headache, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Lysergic Acid Diethylamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2019to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 and ≤ 75 years
- Chronic cluster headache (according to the International Headache Society (IHS) criteria) OR
- Episodic cluster headache (according to the IHS criteria) with recurrent predictable episodes lasting approximately 2 months and expected ongoing cluster period for at least one month beyond the inclusion
- Attacks respond to oxygen
- Sufficient understanding of the study procedures and risks associated with the study
- Participants must be willing to adhere to the study procedures and sign the consent form
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- Participants are willing to abstain from taking preventive and abortive medication (except from oxygen) long enough before and after the LSD/placebo treatment session to avoid the possibility of a drug-drug interaction
- Participants are willing to refrain from taking any psychiatric medications during the experimental session period. If they are being treated with antidepressants, lithium or are taking anxiolytic medications on a fixed daily regimen, such drugs must be discontinued long enough before the LSD/placebo treatment session to avoid the possibility of a drug-drug interaction.
- Participants must also refrain from the use of any psychoactive drugs and caffeine within 24 hours of each LSD/placebo treatment session. They must agree not to use nicotine for at least 2 hours before and 6 hours after each dose of LSD. They must agree to not ingest alcohol-containing beverages for at least 1 day before each LSD treatment session. Non-routine medications for treating breakthrough pain taken in the 24 hours before the LSD treatment session may result in rescheduling the treatment session to another date, with the decision at the discretion of the investigators after discussion with the participant.
- Participants must be willing not to drive a traffic vehicle or to operate machines within 24 hours after LSD/placebo administration.
Who cannot join
- Other forms of headache attacks (migraine, paroxysmal hemicranias, shortlasting unilateral neuralgiform headache attacks with conjunctival injection, tearing, sweating and rhinorrhea (SUNCT) or with cranial autonomic symptoms (SUNA))
- Women who are pregnant, nursing or of child-bearing potential and are not practicing an effective means of birth control (double-barrier method, i.e. pill/intrauterine device and preservative/diaphragm)
- Past or present diagnosis of a primary psychotic disorder. Subjects with a first degree relative with psychotic disorders are also excluded.
- Past or present bipolar disorder (DSM-IV).
- Current substance use disorder (within the last 2 months, DSM-V, except nicotine).
- Somatic disorders including severe cardiovascular disease, untreated hypertension (systolic blood pressure > 160mmHg without treatment, systolic blood pressure > 140 mmHg with treatment), severe liver disease (liver enzymes increase by more than 5 times the upper limit of normal) or severely impaired renal function (estimated creatinine clearance <30 ml/min), or other that in the judgement of the investigators pose too great potential for side effects.
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- Weight < 45kg
- Participation in another clinical trial (currently or within the last 30 days)
- Participants taking higher steroid doses (>10mg/d) over a longer time period (>2 weeks), as this would require tapering
- Use of immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
- Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Basel, 4031
About this study
Official title: Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study
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.
Read more
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.
- Conditions
- Cluster Headache
- Being tested
- Lysergic Acid Diethylamide, Placebo
- Keywords
- lysergic acid diethylamide (LSD), serotonin, hallucinogen, cluster headache
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysergic Acid DiethylamideDrug
Also called LSD
100 µg, per os, 3 times within 3 weeks
PlaceboDrug
placebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| LSD, Placebo | Other | Lysergic acid diethylamide (3 x 100 µg LSD in three weeks, per os) followed by Placebo Receives: Drug: Lysergic Acid Diethylamide; Drug: Placebo |
| Placebo, LSD | Other | Placebo (3 x 1 vial looking like LSD in three weeks, per os) followed by Lysergic acid diethylamide Receives: Drug: Lysergic Acid Diethylamide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of the cluster headache attacks
assessed with a standardized headache diary, within-subjects analysis
Measured: 8 weeks before and after pulse regimen
Change in intensity of the cluster headache attacks
assessed with a standardized headache diary, within-subjects analysis
Measured: 8 weeks before and after pulse regimen
Secondary outcomes (29)
Episode abortion
assessed with a standardized headache diary
Measured: through study completion, an average of 1 year
Change in duration of attacks
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Time to first attack after completion of pulse regimen
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Cumulative time with headache
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Change in cluster period duration and interval between cluster periods
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Number of attacks requiring abortive medication
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Number of Attack-associated autonomic symptoms
assessed with a standardized headache diary
Measured: 8 weeks after pulse regimen
Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36)
assessment with the validated 36-item short-form health survey (SF-36), which measures health-related quality of life
Measured: through study completion, an average of 1 year
Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L)
assessment with the 5-level EuroQoL-5D (EQ-5D-5L), which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life
Measured: through study completion, an average of 1 year
Quality of life assessed by questionnaires: Headache Impact Test (HIT-6)
assessment with the Headache Impact Test (HIT-6), which measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress.
Measured: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: State-trait anxiety inventory (STAI)
assessment with the State-trait anxiety inventory (STAI), which measures anxiety
Measured: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Generalized anxiety disorder-7 (GAD-7)
assessment with the Generalized anxiety disorder (GAD-7), which measures anxiety
Measured: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Hospital Anxiety and Depression Scale (HADS)
assessment with the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression severity
Measured: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Beck Depression Inventory (BDI)
assessment with the Beck Depression Inventory (BDI), which measures depression
Measured: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Patient health questionnaire-9 (PHQ-9)
assessment with the Patient health questionnaire-9 (PHQ-9), which measures depression
Measured: through study completion, an average of 1 year
Acute autonomic effects assessed by blood pressure
systolic and diastolic blood pressure in mmHg
Measured: 10 hours after drug administration
Acute autonomic effects assessed by heart rate
heart rate in beats per minute
Measured: 10 hours after drug administration
Acute autonomic effects assessed by body temperature
body temperature in °Celsius
Measured: 10 hours after drug administration
Adverse Events
adverse events will be recorded
Measured: through study completion, an average of 1 year
Acute psychological effects assessed by questionnaire Visual analogue scales (VAS)
assessment of subjective effects using visual analogue scales
Measured: 10 hours after drug administration
Acute psychological effects assessed by SCQ
assessed with the states of consciousness questionnaire (SCQ)
Measured: 10 hours after drug administration
Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness
assessed with the 5-dimensions of altered states of consciousness questionnaire (5D-ASC)
Measured: 10 hours after drug administration
Persisting effects attributed to the LSD experience
assessment of persisting effects with the persisting effects questionnaire (PEQ) which assesses changes in attitude, mood, behavior and spiritual experience. The questionnaire will be completed at the beginning, after pulse regimens, and at the end of the study.
Measured: through study completion, an average of 1 year
Change of attack frequency at the end of the study compared with baseline
pre-post study comparison in all subjects, assessed with a standardized headache diary
Measured: through study completion, an average of 1 year
Change of attack intensity at the end of the study compared with baseline
pre-post study comparison in all subjects, assessed with a standardized headache diary
Measured: through study completion, an average of 1 year
Change in attack frequency before and after pulse regimen
between-subjects analysis before cross-over, assessed with a standardized headache diary
Measured: 8 weeks after first pulse regimen
Change in attack intensity before and after pulse regimen
between-subjects analysis before cross-over, assessed with a standardized headache diary
Measured: 8 weeks after first pulse regimen
Blinding
patients and investigators will be asked at the end of a study day and and the end of the study visit to guess the drug treatment
Measured: after study days and at the end of study visit
Expectancy
a modified 2-item version of the Credibility / Expectancy Questionnaire (CEQ) will be used
Measured: at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start2 Jan 2019
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, placebo-controlled two-phase cross-over study design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Liechti, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781128
- Sponsor's protocol ID
- BASEC 2018-01082
- Acronym
- LCH
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2018
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study
- ClinicalTrials.gov ID
- NCT03781128
- Acronym / sponsor ID
- LCH / BASEC 2018-01082
- Conditions
- Cluster Headache
- Keywords
- lysergic acid diethylamide (LSD), serotonin, hallucinogen, cluster headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled two-phase cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| LSD, Placebo | Other | Drug: Lysergic Acid Diethylamide, Drug: PlaceboLysergic acid diethylamide (3 x 100 µg LSD in three weeks, per os) followed by Placebo |
| Placebo, LSD | Other | Drug: Lysergic Acid Diethylamide, Drug: PlaceboPlacebo (3 x 1 vial looking like LSD in three weeks, per os) followed by Lysergic acid diethylamide |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 25 and ≤ 75 years
- Chronic cluster headache (according to the International Headache Society (IHS) criteria) OR
- Episodic cluster headache (according to the IHS criteria) with recurrent predictable episodes lasting approximately 2 months and expected ongoing cluster period for at least one month beyond the inclusion
- Attacks respond to oxygen
- Sufficient understanding of the study procedures and risks associated with the study
Key exclusion criteria (11 listed)
- Other forms of headache attacks (migraine, paroxysmal hemicranias, shortlasting unilateral neuralgiform headache attacks with conjunctival injection, tearing, sweating and rhinorrhea (SUNCT) or with cranial autonomic symptoms (SUNA))
- Women who are pregnant, nursing or of child-bearing potential and are not practicing an effective means of birth control (double-barrier method, i.e. pill/intrauterine device and preservative/diaphragm)
- Past or present diagnosis of a primary psychotic disorder. Subjects with a first degree relative with psychotic disorders are also excluded.
- Past or present bipolar disorder (DSM-IV).
- Current substance use disorder (within the last 2 months, DSM-V, except nicotine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysergic Acid DiethylamideAlso: LSD100 µg, per os, 3 times within 3 weeks | Drug | LSD, Placebo, Placebo, LSD |
| Placeboplacebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks | Drug | LSD, Placebo, Placebo, LSD |
Primary outcome
Change in frequency of the cluster headache attacks
Time frame: 8 weeks before and after pulse regimen
assessed with a standardized headache diary, within-subjects analysis
Change in intensity of the cluster headache attacks
Time frame: 8 weeks before and after pulse regimen
assessed with a standardized headache diary, within-subjects analysis
29 secondary outcomes
Episode abortion
Time frame: through study completion, an average of 1 year
Change in duration of attacks
Time frame: 8 weeks after pulse regimen
Time to first attack after completion of pulse regimen
Time frame: 8 weeks after pulse regimen
Cumulative time with headache
Time frame: 8 weeks after pulse regimen
Change in cluster period duration and interval between cluster periods
Time frame: 8 weeks after pulse regimen
Number of attacks requiring abortive medication
Time frame: 8 weeks after pulse regimen
Number of Attack-associated autonomic symptoms
Time frame: 8 weeks after pulse regimen
Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36)
Time frame: through study completion, an average of 1 year
Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L)
Time frame: through study completion, an average of 1 year
Quality of life assessed by questionnaires: Headache Impact Test (HIT-6)
Time frame: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: State-trait anxiety inventory (STAI)
Time frame: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Generalized anxiety disorder-7 (GAD-7)
Time frame: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Hospital Anxiety and Depression Scale (HADS)
Time frame: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Beck Depression Inventory (BDI)
Time frame: through study completion, an average of 1 year
Effects on depressive /anxious symptoms assessed by questionnaires: Patient health questionnaire-9 (PHQ-9)
Time frame: through study completion, an average of 1 year
Acute autonomic effects assessed by blood pressure
Time frame: 10 hours after drug administration
Acute autonomic effects assessed by heart rate
Time frame: 10 hours after drug administration
Acute autonomic effects assessed by body temperature
Time frame: 10 hours after drug administration
Adverse Events
Time frame: through study completion, an average of 1 year
Acute psychological effects assessed by questionnaire Visual analogue scales (VAS)
Time frame: 10 hours after drug administration
Acute psychological effects assessed by SCQ
Time frame: 10 hours after drug administration
Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness
Time frame: 10 hours after drug administration
Persisting effects attributed to the LSD experience
Time frame: through study completion, an average of 1 year
Change of attack frequency at the end of the study compared with baseline
Time frame: through study completion, an average of 1 year
Change of attack intensity at the end of the study compared with baseline
Time frame: through study completion, an average of 1 year
Change in attack frequency before and after pulse regimen
Time frame: 8 weeks after first pulse regimen
Change in attack intensity before and after pulse regimen
Time frame: 8 weeks after first pulse regimen
Blinding
Time frame: after study days and at the end of study visit
Expectancy
Time frame: at screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Liechti principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lysergic Acid Diethylamide in people with Cluster Headache, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of the cluster headache attacks (time frame: 8 weeks before and after pulse regimen). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.