Psilocybin for the Treatment of Cluster Headache

Yale University

Status and phase: Completed; Phase 1

Conditions: Cluster Headache

Treatments: Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin; Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02981173

1607018057

Details and patient eligibility

About

The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.

Enrollment: 25 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic cluster headache with at least one attack daily
• Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
• Attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)

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, lysergic acid diethylamide (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 five half-lives of test days
• Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
• Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) in the past 6 weeks
• Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 3 patient groups, including a placebo group

Psilocybin High Dose

Active Comparator group

Treatment:

Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin

Psilocybin Low Dose

Active Comparator group

Treatment:

Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo