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New treatment option for Migraine
Official title Mechanistic Studies of Psilocybin in Headache Disorders
ClinicalTrials.gov ID: NCT06464367
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine.
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
- In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age 21 to 70 (inclusive)
- Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient Exclusion criterion
- Unstable medical condition or serious nervous system pathology
- Pregnant, breastfeeding, lack of adequate birth control
- Psychotic or manic disorder
See the full eligibility criteria
- Age 21 to 70 (inclusive)
- Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient Exclusion criterion
- Unstable medical condition or serious nervous system pathology
- Pregnant, breastfeeding, lack of adequate birth control
- Psychotic or manic disorder
- Substance abuse in the prior 3 months
- Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months
- Use of cannabis or other THC products in the prior 2 weeks
- Urine toxicology positive to drugs of abuse
- The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
- Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks
- Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks...
- History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).
- Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
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, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States. 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.