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Migraine HeadachePhase 1NCT03341689

Psilocybin for the Treatment of Migraine Headache

A Phase 1 study testing High Dose Psilocybin and Low Dose Psilocybin in people with Migraine Headache, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Migraine Headache
What is being tested?
High Dose Psilocybin and Low Dose Psilocybin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
1 Nov 2017to 31 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of migraine headache per ICHD-3beta criteria
  • Typical pattern of migraine attacks with approximately two migraines or more weekly
  • Attacks are managed by means involving no more than twice weekly triptan use
  • Age 21 to 65

Who cannot join

  • Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
  • Axis I psychotic disorder in first degree relative
  • Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
  • Pregnant, breastfeeding, lack of adequate birth control
  • History of intolerance to psilocybin, LSD, or related compounds
  • Drug or alcohol abuse within the past 3 months (excluding tobacco)
Show all 11Show fewer
  • Urine toxicology positive to drugs of abuse
  • Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
  • Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
  • Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
  • Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Connecticut Healthcare System, West Haven Campus

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.

Read the detailed description

The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.

Being tested
High Dose Psilocybin, Low Dose Psilocybin, Placebo
Keywords
Psilocybin
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose PsilocybinDrug

    0.143 mg/kg psilocybin capsule

  • Low Dose PsilocybinDrug

    0.0143 mg/kg psilocybin capsule

  • PlaceboDrug

    microcrystalline cellulose capsule

Study groups in NCT03341689
Study groupRoleWhat they receive
Placebo/Low Dose PsilocybinExperimentalSubjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Receives: Drug: Low Dose Psilocybin; Drug: Placebo
Placebo/High Dose PsilocybinExperimentalSubjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Receives: Drug: High Dose Psilocybin; Drug: Placebo
Low Dose Psilocybin/PlaceboExperimentalSubjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Receives: Drug: Low Dose Psilocybin; Drug: Placebo
High Dose Psilocybin/PlaceboExperimentalSubjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Receives: Drug: High Dose Psilocybin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in migraine headache days

    Average days (number of days per week)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  2. Change in migraine attack frequency

    Average number (number per week)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  3. Change in migraine attack duration

    Average duration (measured in hours)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  4. Change in pain intensity of migraine attacks

    Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  5. Change in intensity of nausea/vomiting during migraine attacks

    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  6. Change in intensity of photophobia

    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  7. Change in intensity of phonophobia

    Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  8. Change in migraine attack-related functional disability

    Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

Secondary outcomes (8)

  1. Change in the use of abortive/rescue medication

    number of days (number of days per week using a migraine abortive)

    Measured: From two weeks before first session to two weeks after second session using a headache diary

  2. Time to first migraine attack

    Measured in days

    Measured: From the day of each session until two weeks after each test session

  3. Time to second migraine attack

    Measured in days

    Measured: From the day of each session until two weeks after each test session

  4. Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module

    4 questions scored 0 to 30 each; higher numbers indicate worse quality of life.

    (1) pain-related impairment, (2) mood symptoms, (3) anxiety symptoms, and (4) lack of sleep Percent change for each measure as well as total score (range 0 to 120) will be calculated.

    Measured: From two weeks before first session to three months after second session using a headache diary

  5. Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale

    94 questions scored 0 to 100 each; higher numbers indicate greater psychedelic effects Questions address 5 dimensions: (1) Oceanic boundlessness (score range 0-2700), (2) Dread of Ego Dissolution (score range 0-2100), (3) Visionary Restructuralization (score range 0-1800), (4) Auditory Alterations (score range 0-1600), and (5) Vigilance reduction (score range 0-1200) Score for each dimension as well as total score (range 0 to 9400) will be measured.

    Measured: Taken on each test day approximately 6 hours after drug administration

  6. Change in blood pressure

    Maximum change in mean arterial blood pressure from baseline during each test day (mmHg)

    Measured: Measured during each test session prior to drug administration, every 15 minutes in the first hour, every 30 minutes in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

  7. Change in heart rate

    Maximum change from baseline during each test day (beats per minute)

    Measured: Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

  8. Change in peripheral oxygenation

    Maximum change from baseline during each test day (SpO2)

    Measured: Measured during each test session prior to drug administration, every 15 min in the first hour, every 30 min in the second hour, and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start1 Nov 2017
  3. Primary completion30 Apr 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03341689
Sponsor's protocol ID
1607018057.A
Status last verified
Oct 2023
First submitted
9 Nov 2017
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schindler EAD, Sewell RA, Gottschalk CH, Luddy C, Flynn LT, Lindsey H, Pittman BP, Cozzi NV, D'Souza DC. Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin. Neurotherapeutics. 2021 Jan;18(1):534-543. doi: 10.1007/s13311-020-00962-y. Epub 2020 Nov 12.

    PubMed 33184743

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing High Dose Psilocybin and Low Dose Psilocybin in people with Migraine Headache, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in migraine headache days (time frame: From two weeks before first session to two weeks after second session using a headache diary). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03341689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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