Psilocybin for Migraine

VA Connecticut Healthcare System, West Haven, CT

Psilocybin +1 morePhase 1RecruitingResearch Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of migraine headache per ICHD-3 criteria

Typical pattern of migraine attacks with approximately two migraines or more weekly

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom two weeks before the first session to two months after second session using a headache diary

Awards & highlights

Study Summary

This trial will study the effects of psilocybin on migraine headaches, specifically looking at neuroinflammatory markers.

Eligible Conditions

Migraine

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have been diagnosed with migraine headaches according to specific criteria set by medical experts.

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You experience frequent migraines, having at least two or more per week.

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You have been diagnosed with migraine headache based on specific medical criteria.

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You have migraines happening about twice or more a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from two weeks before the first session to two months after second session using a headache diary

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from two weeks before the first session to two months after second session using a headache diary

This trial's timeline: 3 weeks for screening, Varies for treatment, and from two weeks before the first session to two months after second session using a headache diary for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average intensity of nausea/vomiting

Change in duration of migraine attacks

Change in functional disability

+4 more

Secondary outcome measures

Change in blood pressure- Diastolic

Change in blood pressure- Systolic

Change in heart rate

+8 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Thrombocytosis

Constipation

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Dizziness

Hypoesthesia

Migraine

Sedation

Anger

Anxiety

Cough

Rhinorrhea

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Vomiting

Influenza like Illness

Gingivitis

Restlessness

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

4Treatment groups

Experimental Treatment

Group I: Psilocybin/PsilocybinExperimental Treatment1 Intervention

Subjects will receive a dose of psilocybin, followed by a dose of psilocybin approximately 7 days later.

Group II: Psilocybin/PlaceboExperimental Treatment2 Interventions

Subjects will receive a dose of psilocybin, followed by a dose of placebo approximately 7 days later.

Group III: Placebo/PsilocybinExperimental Treatment2 Interventions

Subjects will receive a dose of placebo, followed by a dose of psilocybin approximately 7 days later.

Group IV: Placebo/PlaceboExperimental Treatment1 Intervention

Subjects will receive a dose of placebo, followed by a dose of placebo approximately 7 days later.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

Wallace Research FoundationUNKNOWN

1 Previous Clinical Trials

3 Total Patients Enrolled

Yale UniversityLead Sponsor

1,760 Previous Clinical Trials

2,689,427 Total Patients Enrolled

1 Trials studying Migraine

14 Patients Enrolled for Migraine

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04218539 — Phase 1

Migraine Research Study Groups: Placebo/Placebo, Placebo/Psilocybin, Psilocybin/Placebo, Psilocybin/Psilocybin

Migraine Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04218539 — Phase 1

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218539 — Phase 1

Migraine Patient Testimony for trial: Trial Name: NCT04218539 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an age requirement and, if so, does it include persons over 50?

"This medical experiment is enrolling adults aged between 21 and 65."

Answered by AI

Has recruitment begun for this particular trial yet?

"Clinicaltrials.gov suggests that patient recruitment for this medical trial is ongoing, with the initial posting on August 10th 2021 and the latest update occurring on September 2nd 2022."

Answered by AI

How many volunteers are currently engaged in the research project?

"Affirmative, according to clinicaltrials.gov this study is actively searching for enrollees. This trial was initially posted on August 10th 2021 and the most recent update came on September 2nd 2022, with a goal of recruiting 24 patients from one medical centre."

Answered by AI

What is the fundamental aim of this medical trial?

"The core purpose of this medical experiment, which will measure results over a period beginning two weeks before the first session and ending two months after the second one via headache diaries, is to observe any shifts in migraine frequency. Secondary objectives include transitions in peripheral oxygenation (maximum change from baseline during each test day), number of days until initial onset of migraines, and amount of 24-hour consecutive or nonconsecutive intervals free from headaches."

Answered by AI

Has the FDA sanctioned Psilocybin for use in clinical treatments?

"As this is still in the early stages of investigation, Power's team has assigned a conservative rating of 1 to Psolocybin based on their assessment of current data relating to safety and efficacy."

Answered by AI

What prior experiments have been done using Psilocybin as a drug?

"Currently, there are 33 studies involving psilocybin that remain active and none of them have reached phase 3. Most of these medical trials occur in Vancouver, Washington but a total of 36 sites across the USA are participating."

Answered by AI

What requirements must be met to qualify for this trial?

"This clinical trial is open to 24 subjects aged 21-65 with migraine. To be considered, participants should not take more than two triptan medications per week for their migraines."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

Texas

Connecticut

Other

How old are they?

65+

18 - 65

What site did they apply to?

VA Connecticut Healthcare System

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have recurring migraines and other inflammation-related conditions. I'm wondering if psilocybin could help me.

Patient

I have some experience with psilocybin and have had very positive after effects or reduced migraines and a clarity that is immediately evident, lasting for weeks afterward.

Patient