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Psychedelic Therapy

Psilocybin for Headaches

Phase < 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient
Age 21 to 70 (inclusive)
Must not have
Psychotic or manic disorder
The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first mri to the date of second mri, assessed up to 6 months

Summary

"This trial aims to understand why psilocybin can reduce headaches by studying brain activity, synaptic density, inflammation markers, circadian rhythm, and sleep patterns before and after administering psilocybin or

Who is the study for?
This trial is for individuals with headache disorders, specifically migraines. Participants should be healthy otherwise and willing to undergo brain imaging and sleep studies before and after taking psilocybin or a placebo. The exact eligibility criteria are not provided.
What is being tested?
The study tests the effects of psilocybin on headaches by comparing it to a placebo. It measures changes in brain connectivity, synaptic density, inflammation markers, circadian rhythms, and sleep patterns before and one week after administration.
What are the potential side effects?
While specific side effects are not listed here, psilocybin can typically cause sensory alterations, mood changes, nausea, headache post-use (ironically), or psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with migraines according to ICHD-3 or I am a healthy volunteer.
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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a psychotic or manic disorder.
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I use migraine medication like triptans or ditans more than twice a week.
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I do not have any unstable health conditions or serious nervous system issues.
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I have a bleeding disorder or am currently on blood thinners.
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I have not taken chronic serotonergic medications like amitriptyline or fluoxetine in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first mri to the date of second mri, assessed up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first mri to the date of second mri, assessed up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline RSFC
Baseline SV2A PET
Change in SV2A PET after drug administration
+1 more
Secondary study objectives
Adverse events
Change in IL-1beta
Change in IL-6
+10 more
Other study objectives
Acute change in IL-1beta during drug administration
Acute change in IL-6 during drug administration
Acute change in SpO2 during drug administration
+7 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Migraine psilocybinExperimental Treatment1 Intervention
Migraine participants randomized to receive 10 mg psilocybin (oral)
Group II: Healthy control psilocybinExperimental Treatment1 Intervention
Healthy control participants randomized to receive 10 mg psilocybin (oral)
Group III: Migraine placeboPlacebo Group1 Intervention
Migraine participants randomized to receive 2.5 mg THC (oral)
Group IV: Healthy control placeboPlacebo Group1 Intervention
Healthy control participants randomized to receive 2.5 mg THC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,608 Total Patients Enrolled
3 Trials studying Migraine
232 Patients Enrolled for Migraine
Wallace Research FoundationUNKNOWN
3 Previous Clinical Trials
37 Total Patients Enrolled
1 Trials studying Migraine
18 Patients Enrolled for Migraine
~33 spots leftby Dec 2026
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