Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II

ID
Name
1607018057.B
Description
The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.
Trial arms
Trial start
2019-03-28
Estimated PCD
2023-06-27
Trial end
2023-06-27
Status
Terminated
Phase
Early phase I
Treatment
Placebo oral capsule
microcrystalline cellulose capsule
Arms:
High Dose Psilocybin/Placebo, Low Dose Psilocybin/Placebo, Placebo/High Dose Psilocybin, Placebo/Low Dose Psilocybin
Low Dose Psilocybin
0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)
Arms:
High Dose Psilocybin/Low Dose Psilocybin, Low Dose Psilocybin/High Dose Psilocybin, Low Dose Psilocybin/Placebo, Placebo/Low Dose Psilocybin
High Dose Psilocybin
0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)
Arms:
High Dose Psilocybin/Low Dose Psilocybin, High Dose Psilocybin/Placebo, Low Dose Psilocybin/High Dose Psilocybin, Placebo/High Dose Psilocybin
Size
12
Primary endpoint
Acute change in pain intensity
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in nausea/vomiting
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in photophobia
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in phonophobia
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Acute change in functional disability
Measured at 0, 1, 2, 4, and 24 hours after drug administration
Time to first headache attack
Two weeks following each test session
Time to last headache attack
Two weeks following each test session
Change in headache attack frequency
From two weeks before first session to two weeks after second session using a headache diary
Change in headache attack duration
From two weeks before first session to two weeks after second session using a headache diary
Change in pain intensity of headache attacks
From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of nausea/vomiting during headache attacks
From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of photophobia during headache attacks
From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of phonophobia during headache attacks
From two weeks before first session to two weeks after second session using a headache diary
Change in intensity of functional disability during headache attacks
From two weeks before first session to two weeks after second session using a headache diary
Eligibility criteria
Inclusion Criteria: * Diagnosis of post-traumatic headache * Typical pattern of headache attacks with approximately two attacks or more weekly * Attacks are managed by means involving no more than twice weekly triptan use 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2023-10-12

1 organization

2 products

1 indication

Organization
Yale University
Product
Placebo
Indication
Post-Traumatic Headache
Product
Psilocybin