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Study Summary
This trial will study the effects of psilocybin on migraine headaches, specifically looking at neuroinflammatory markers.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT02061293Trial Design
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- 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.
- Group 1: Placebo/Placebo
- Group 2: Placebo/Psilocybin
- Group 3: Psilocybin/Placebo
- Group 4: Psilocybin/Psilocybin
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- VA Connecticut Healthcare System: < 24 hours
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