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

NCT05128162 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HUM00208367
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Heart Rate Beats Per Minute (BPM) - First Dose (15 mg)

  BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.

  Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

• Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg)

  BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.

  Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

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

  Systolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Systolic BP greater than 200 for more than 15 minutes was considered to be an adverse event.

  Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

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

  BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Systolic BP greater than 200 for more than 15 minutes was considered to be an adverse event.

  Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

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

  Diastolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. BP greater than 110 diastolic for more than 15 minutes was considered to be an adverse event.

  Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

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

  Diastolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. BP greater than 110 diastolic for more than 15 minutes was considered to be an adverse event.

  Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose

• Adverse Events (AE) Incidence

  Results reflect the total number of all adverse events that occurred during the trial.

  Day 1 through Day 64

Secondary Outcomes (5)

• Change in Pain Interference

  Day 1 and Day 64

• Sleep Disturbance

  Day 1 and Day 64

• Chronic Pain Acceptance

  Day 1 and Day 64

• Patient Global Impression of Change (PGI-C)

  Day 64

• Chronic Pain Intensity Between Groups in the Study Period

  Days 1-7 & Days 57-63

Study Arms (1)

Open Label Oral Psilocybin

EXPERIMENTAL

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.

Drug: Psilocybin; Behavioral: Psychotherapy

Interventions

Psilocybin DRUG

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

Open Label Oral Psilocybin

Psychotherapy BEHAVIORAL

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

Open Label Oral Psilocybin

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age
• \- Participant must be 25 to 64 years of age, inclusive, at the time of signing the informed consent form.
• Type of Participant and Disease Characteristics
• Participant must meet "criteria for FM per the 2016 FM survey criteria."
• Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
• Participant must be a non-smoker (tobacco).
• Participant must be medically stable as determined by screening for medical problems via a personal interview and/or, a medical questionnaire, and an ECG, within 1 month of starting active intervention (performed during screening).
• Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea, cola) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the participant does not routinely consume caffeinated beverages, he/she must agree to not do so on psilocybin session days.
• Participant must agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours before and after each psilocybin administration. The exception is caffeine.
• Participant must agree to not take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours before and after each psilocybin administration.
• Participant must agree to not take any pro re nata (PRN) medications on the mornings of psilocybin sessions.
• Participant must agree that for 7 days before each psilocybin session, he/she will refrain from taking any nonprescription medication, cannabis, nutritional supplement, or herbal supplement except when approved by the Principal Investigator. Exceptions will be evaluated by the Principal Investigator and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
• Participant must have at least a high school level of education or equivalent (e.g., General Educational Development \[GED\] Test).
• Sex and Contraceptive/Barrier Requirements

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Participant has had (within the past 1 year) a cardiovascular condition such as coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \> 450 msec), artificial heart valve, or transient ischemic attack.
• Participant has epilepsy with a history of seizures.
• Participant has insulin-dependent diabetes.
• Participant is taking an oral hypoglycemic agent and has a history of hypoglycemia.
• Participant has active auto-immune disease (e.g., lupus, rheumatoid arthritis).
• Participant has a current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I or II disorder measured via SCID-5 and SCID-5-PD.
• Participant has a current or past history (within 1 year) of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, or other drug use disorder (excluding caffeine) measured via relevant questions from the SCID-5.
• Participant has a history of a medically significant suicide attempt.
• Prior/Concomitant Therapy
• Participant is taking psychoactive prescription medication (e.g., opioids, tramadol, benzodiazepines) on a regular basis (i.e., more than 2 times a week).
• Participant is currently taking an antidepressant. Participants will also be required to refrain from using antidepressant medications through the completion of primary outcome assessments. Note: if a participant self-initiates a medication taper with the consent and support of their physician, they can re-screen after the appropriate time period.
• Participant is currently taking bupropion or antidepressants other than selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs).
• Participant is currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.

Sponsors & Collaborators

• Kevin Boehnke: lead

Study Sites (1)

Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• Aday JS, McAfee J, Conroy DA, Hosanagar A, Tarnal V, Weston C, Scott K, Horowitz D, Geller J, Harte SE, Pouyan N, Glynos NG, Baker AK, Guss J, Davis AK, Burgess HJ, Mashour GA, Clauw DJ, Boehnke KF. Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial. Front Pain Res (Lausanne). 2025 Mar 18;6:1527783. doi: 10.3389/fpain.2025.1527783. eCollection 2025.

  PMID: 40171515 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Psilocybin; Psychotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Kevin Boehnke, PhD
• Organization: University of Michigan

kboehnke@med.umich.edu

734-998-6939

Study Officials

• Kevin F Boehnke, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 19, 2021
• Study Start: September 27, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)