← Back to Search

Psychedelic

Psilocybin + Psychotherapy for Fibromyalgia

Phase 2

Recruiting

Led By Kevin F Boehnke, PhD

Research Sponsored by Kevin Boehnke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 25 to 64 years of age, inclusive, at the time of signing the informed consent form.

Females of reproductive potential must use effective birth control for the duration of active intervention.

Must not have

Participant is currently taking an antidepressant.

Participant is taking an oral hypoglycemic agent and has a history of hypoglycemia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 64

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether psilocybin therapy can help relieve fibromyalgia symptoms when used in combination with psychotherapy.

Who is the study for?

Adults aged 25-64 with fibromyalgia for at least 3 months, stable in psychotherapy, non-smokers, and not using certain medications can join. They must avoid psychoactive substances before sessions and women of childbearing potential need effective birth control.

What is being tested?

The trial tests the combination of oral psilocybin (a psychedelic compound) with psychotherapy to see if it helps reduce chronic pain in fibromyalgia patients. Participants will take psilocybin under controlled conditions alongside their ongoing therapy.

What are the potential side effects?

Psilocybin may cause temporary changes in perception, mood swings, dizziness, nausea or headaches. Psychotherapy has minimal side effects but can sometimes bring up uncomfortable emotions as part of the therapeutic process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 64 years old.

Select...

I am using effective birth control and will continue to do so during the treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on antidepressant medication.

Select...

I am taking diabetes medication and have had low blood sugar episodes.

Select...

I have epilepsy and a history of seizures.

Select...

I have diabetes that requires insulin treatment.

Select...

I have been diagnosed with severe depression.

Select...

I am sexually active and not using effective birth control.

Select...

I have a close relative with schizophrenia, bipolar disorder, or another psychotic disorder.

Select...

I regularly take prescribed medication for my mental health.

Select...

I am currently taking medication that affects serotonin in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AE) Incidence

Blood Pressure (BP) - First Dose (15 mg)

Blood Pressure (BP) - Second Dose (25 mg)

+2 more

Secondary study objectives

Chronic Pain Acceptance

Chronic pain intensity between groups in the study period

Pain interference

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open Label Oral PsilocybinExperimental Treatment2 Interventions

This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychotherapy

2014

Completed Phase 3

~3440

Psilocybin

2021

Completed Phase 2

~530