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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 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.
Who is the study for?
This trial is for individuals who have been diagnosed with migraine headaches according to ICHD-3 criteria and experience about two or more migraines weekly. Participants should not be using triptans more than twice a week. People with psychotic disorders, severe medical conditions, pregnant or breastfeeding women, those intolerant to psilocybin/LSD, recent drug abusers, heavy alcohol users, and those on certain medications are excluded.Check my eligibility
What is being tested?
The study is testing the effect of single and repeated doses of Psilocybin compared to a placebo in reducing the burden of migraine headaches. It will also measure neuroinflammatory markers to explore how Psilocybin might affect migraines.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from Psilocybin may include nausea, sensory alteration (like seeing bright colors), mood changes (feeling extremely happy or sad), anxiety or panic reactions especially if one has had negative experiences with similar substances before.
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
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 moreSecondary outcome measures
Change in blood pressure- Diastolic
Change in blood pressure- Systolic
Change in heart rate
+8 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
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
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
Find a Location
Who is running the clinical trial?
Wallace Research FoundationUNKNOWN
2 Previous Clinical Trials
19 Total Patients Enrolled
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,650 Total Patients Enrolled
1 Trials studying Migraine
14 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with migraine headaches according to specific criteria.You have frequent migraines, about two or more every week.You have a severe mental illness like schizophrenia or bipolar disorder.A close family member has a serious mental health condition like schizophrenia or bipolar disorder.You have tested positive for drugs in a urine test.You have taken certain types of antidepressant medications in the last 6 weeks.You have had a bad reaction to psilocybin, LSD, or similar substances in the past.You have used illegal drugs, except for tobacco, in the last 3 months.You drink more than 21 drinks per week if you're a male, or more than 14 drinks per week if you're a female, according to NIAAA guidelines.You have taken certain medications that narrow blood vessels within a specific timeframe before the test days.You have used Botox or certain medications for migraine in the past month, or the effects of those medications are still active in your body.You have consumed alcohol within the week before the first test day.You have taken certain anti-nausea medications, like ondansetron, in the last 2 weeks.You use triptans for treating attacks no more than twice a week.You have taken steroids or certain other immune system-modifying drugs in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Placebo
- Group 2: Placebo/Psilocybin
- Group 3: Psilocybin/Placebo
- Group 4: Psilocybin/Psilocybin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
2
3+
0
What questions have other patients asked about this trial?
Are you still recruiting ?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have recurring migraines and other inflammation-related conditions. I'm wondering if psilocybin could help me.
PatientReceived 2+ prior treatments
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.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- VA Connecticut Healthcare System: < 24 hours
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