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Psilocybin for the Treatment of Migraine Headache

NCT03341689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-10-12

No results posted yet for this study

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. 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.

Conditions

  • Migraine Headache

Interventions

DRUG

High Dose Psilocybin

0.143 mg/kg psilocybin capsule

DRUG

Low Dose Psilocybin

0.0143 mg/kg psilocybin capsule

DRUG

Placebo

microcrystalline cellulose capsule

Sponsors & Collaborators

  • Ceruvia Lifesciences

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-04-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03341689 on ClinicalTrials.gov