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Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

NCT05128162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-16

Study results available
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Summary

The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to treat chronic pain symptoms in patients with FM.

Conditions

  • Fibromyalgia

Interventions

DRUG

Psilocybin

Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart.

BEHAVIORAL

Psychotherapy

1\. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.

Sponsors & Collaborators

  • Kevin Boehnke

    lead OTHER

Principal Investigators

  • Kevin F Boehnke, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2024-06-12
Completion
2024-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05128162 on ClinicalTrials.gov