- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341689
Psilocybin for the Treatment of Migraine Headache
October 10, 2023 updated by: Deepak C. D'Souza, Yale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System, West Haven Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
|
0.0143 mg/kg psilocybin capsule
microcrystalline cellulose capsule
|
Experimental: Placebo/High Dose Psilocybin
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
|
microcrystalline cellulose capsule
0.143 mg/kg psilocybin capsule
|
Experimental: Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
|
0.0143 mg/kg psilocybin capsule
microcrystalline cellulose capsule
|
Experimental: High Dose Psilocybin/Placebo
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
|
microcrystalline cellulose capsule
0.143 mg/kg psilocybin capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in migraine headache days
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average days (number of days per week)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in migraine attack frequency
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average number (number per week)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in migraine attack duration
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average duration (measured in hours)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in pain intensity of migraine attacks
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average pain intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in intensity of nausea/vomiting during migraine attacks
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in intensity of photophobia
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in intensity of phonophobia
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average intensity (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Change in migraine attack-related functional disability
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
Average disability (4-tiered pain score; 0=none, 1=mild, 2=moderate, 3=severe)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the use of abortive/rescue medication
Time Frame: From two weeks before first session to two weeks after second session using a headache diary
|
number of days (number of days per week using a migraine abortive)
|
From two weeks before first session to two weeks after second session using a headache diary
|
Time to first migraine attack
Time Frame: From the day of each session until two weeks after each test session
|
Measured in days
|
From the day of each session until two weeks after each test session
|
Time to second migraine attack
Time Frame: From the day of each session until two weeks after each test session
|
Measured in days
|
From the day of each session until two weeks after each test session
|
Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module
Time Frame: From two weeks before first session to three months after second session using a headache diary
|
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. |
From two weeks before first session to three months after second session using a headache diary
|
Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale
Time Frame: Taken on each test day approximately 6 hours after drug administration
|
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.
|
Taken on each test day approximately 6 hours after drug administration
|
Change in blood pressure
Time Frame: 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)
|
Maximum change in mean arterial blood pressure from baseline during each test day (mmHg)
|
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)
|
Change in heart rate
Time Frame: 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)
|
Maximum change from baseline during each test day (beats per minute)
|
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)
|
Change in peripheral oxygenation
Time Frame: 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)
|
Maximum change from baseline during each test day (SpO2)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 9, 2017
First Posted (Actual)
November 14, 2017
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1607018057.A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine Headache
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
-
Ariston Pharmaceuticals, Inc.UnknownMigraine | Migraine Disorders | Migraine Headache | Migraine Without Aura | Migraine With AuraFinland, Netherlands, United Kingdom
-
Click Therapeutics, Inc.Active, not recruitingMigraine | Headache | Headache, Migraine | Episodic MigraineUnited States
-
Click Therapeutics, Inc.Active, not recruitingMigraine | Headache | Headache, Migraine | Episodic MigraineUnited States
-
Danish Headache CenterCompletedHeadache, Migraine | AuraDenmark
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Nanfang Hospital, Southern Medical UniversityBrainClos Co., LTD.; Zhuhai Fudan Innovation InstituteNot yet recruitingCluster Headache | Migraine in Children | Tension Headache | Migraine in Adolescence | Primary HeadacheChina
-
Danish Headache CenterCompletedMigraine Headache | Migraine Without AuraDenmark
-
Behar, Caren, M.D.UnknownMigraine | Migraine Disorders | Migraine Headache | Acute MigraineUnited States
-
Children's Hospital Medical Center, CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMigraine | Migraine Disorders | Headache | Headache Disorders | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Low Dose Psilocybin
-
Yale UniversityHeffter Research InstituteActive, not recruitingMajor Depressive DisorderUnited States
-
Yale UniversityTerminated
-
Brugmann University HospitalNot yet recruitingSevere Alcohol Use Disorder
-
University of Colorado, DenverNot yet recruitingAnhedonia | Major Depressive Disorder | Treatment Resistant DepressionUnited States
-
Johns Hopkins UniversityCompletedHealthyUnited States
-
University of Texas at AustinNot yet recruitingDepression | Major Depressive Disorder | Treatment Resistant Depression | MDD | Recurrent DepressionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedPneumonia | Coronavirus Infection in 2019 (COVID-19) | Severe Acute Respiratory Syndrome (SARS) PneumoniaUnited States
-
MedImmune LLCCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)United States, Puerto Rico
-
Beijing Northland Biotech. Co., Ltd.CompletedSafety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionAcute Myocardial InfarctionChina