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New treatment option for Cluster Headache
Official title Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
ClinicalTrials.gov ID: NCT03781128
What this study is testing
What is Lysergic Acid Diethylamide?
Lysergic Acid Diethylamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cluster headache.
Also referred to as LSD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 75
You may be able to join if
- 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...
- Attacks respond to oxygen
- Sufficient understanding of the study procedures and risks associated with the study
You likely can't join if
- Other forms of headache attacks (migraine, paroxysmal hemicranias, shortlasting unilateral neuralgiform headache attacks with conjunctival injection...
- 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...
- Past or present diagnosis of a primary psychotic disorder. people 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...
See the full eligibility criteria
- 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
- 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...
- 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...
- Participants must be willing not to drive a traffic vehicle or to operate machines within 24 hours after LSD/placebo administration.
- 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...
- 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. people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.