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Psilocybin for the Treatment of Cluster Headache

NCT02981173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Cluster Headache

Interventions

DRUG

0.143 mg/kg Psilocybin or 10 mg Psilocybin

0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)

DRUG

0.0143 mg/kg Psilocybin or 1 mg Psilocybin

0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)

DRUG

Placebo

Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)

Sponsors & Collaborators

  • Heffter Research Institute

    collaborator OTHER

  • Ceruvia Lifesciences

    collaborator UNKNOWN

  • CH TAC LLC

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2022-06-30
Completion
2022-10-21

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 NCT02981173 on ClinicalTrials.gov