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.
Topic Pain
Headache Disorders
Compound Placebo
Psilocybin
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
11 January 2017
End date
01 June 2023
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
24
Sex
All
Age
21- 65
Therapy
No
Trial Details
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.NCT Number NCT03341689
Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.
Papers
Exploratory Controlled Study of the Migraine-Suppressing Effects of PsilocybinThis double-blind, placebo-controlled, cross-over study (n=10) finds that a medium dose of psilocybin (10mg/70kg) significantly reduced migraines (headaches) in the two weeks after dosing.
Measures Used
5-Dimensional Altered States of Consciousness QuestionnaireThe 5D-ASC scale measures altered states of consciousness and contains 94 items (visual analog scales).