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FibromyalgiaPhase 2NCT05128162

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

A Phase 2 study testing Psilocybin and Psychotherapy in people with Fibromyalgia, run by Kevin Boehnke at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 64 years
Conditions the study is for
Fibromyalgia
What is being tested?
Psilocybin and Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
27 Sep 2023to 12 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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
  • Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Females of reproductive potential must agree to use effective birth control for the duration of active intervention (defined as the time from the Baseline [deep phenotyping] visit until the EOT [deep phenotyping] visit).
  • Sexually active male participants and/or their female partners must agree to use effective birth control for the duration of active intervention (defined as the time from the Baseline [deep phenotyping] visit until the EOT [deep phenotyping] visit) of the male participant. Male participants must also agree not to donate sperm for the duration of active intervention.
  • Informed Consent
  • Participant has provided informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • 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.
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  • 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.
  • Participant tests above 0.02% blood alcohol content on breath alcohol testing and/or positive for cocaine, methamphetamine, or opioids on urine drug testing.
  • Participant has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
  • Prior/Concurrent Clinical Study Experience
  • Participant is currently in another clinical trial.
  • Diagnostic assessments
  • Participant has a significant suicide risk as defined by:
  • suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year at Screening or at Baseline; or
  • suicidal behaviors within the past year; or
  • clinical assessment of significant suicidal risk during participant interviews
  • Participant has severe depression as measured through PHQ-8 at Screening.
  • Other Exclusions
  • Participant is pregnant (as indicated by a positive urine pregnancy test assessed at Screening and before each psilocybin session) or nursing.
  • Participant is a WOCBP and sexually active, or a man and sexually active, and not practicing an effective means of birth control.
  • Participant has a confirmed first- or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I or II disorder.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chronic Pain and Fatigue Research Center

    Ann Arbor, Michigan, 48106

Other trials in United States

About this study

Official title: A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia

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.

Read the detailed description

Fibromyalgia is a chronic syndrome of widespread musculoskeletal pain that often manifests with a cluster of co-occurring symptoms, including sleep disturbances, fatigue, cognitive dysfunction, and mood problems including anxiety and depression. Recent studies have provided evidence of altered central pain pathways. Current management of FM typically takes a multidimensional approach including behavioral therapy, exercise, and medication. However, current medications provide only modest benefit and carry significant side effect burden, leading many people with FM to seek other alternatives.

Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM. Indeed, psilocybin therapy has shown positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. The United States Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for psilocybin in treatment-resistant depression and major depressive disorder. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. While no clinical studies have explored psychedelic effects among people with FM, a recent review outlined potential mechanisms through which psychedelics could alleviate chronic pain symptoms.

Conditions
Fibromyalgia
Being tested
Psilocybin, Psychotherapy
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

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

  • PsychotherapyBehavioural

    1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Study groups in NCT05128162
Study groupRoleWhat they receive
Open Label Oral PsilocybinExperimentalThis 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.
Receives: Drug: Psilocybin; Behavioral: Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. Adverse Events (AE) Incidence

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

    Measured: Day 1 through Day 64

Secondary outcomes (5)

  1. Change in Pain Interference

    Pain interference is the degree to which pain affects important aspects of an individual's life, such as social, cognitive, and physical activities. Pain interference was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference scale from the PROMIS-29+2 Profile v2.1 (PROPr). The raw scores were converted to standardized T-scores, with 50 as the population mean with a standard deviation of 10, and higher scores indicating worse pain interference.

    Measured: Day 1 and Day 64

  2. Sleep Disturbance

    Sleep disturbance included assessment of sleep quality, perceived ability to fall and stay asleep, satisfaction of sleep, and depth of sleep. Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. The raw scores were converted to standardized T-scores, with 50 as the population mean with a standard deviation of 10, and higher scores indicating worse sleep disturbance.

    Measured: Day 1 and Day 64

  3. Chronic Pain Acceptance

    Chronic Pain Acceptance was measured using that Chronic Pain Acceptance Questionnaire-8 (CPAQ-8) that assessed activity engagement and pain willingness (e.g., recognizing that trying to avoid or control pain may be maladaptive for chronic pain). The lowest possible score was 0 (full chronic pain acceptance) and the highest possible score was 48 (no chronic pain acceptance).

    Measured: Day 1 and Day 64

  4. Patient Global Impression of Change (PGI-C)

    The PGI-C was a questionnaire that gauged the participant's response to medical interventions using a 7-point Likert scale ranging from 1 to 7 with 1 being "very much improved" and 7 being "very much worse".

    Measured: Day 64

  5. Chronic Pain Intensity Between Groups in the Study Period

    Aggregated worst pain intensity scale from 0 (no pain) to 10 (highest pain possible) during 7-day epochs from day 1 through day 64. Participants' scores from Days 1-7 and Days 57-63 were compared.

    Measured: Days 1-7 & Days 57-63

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start27 Sep 2023
  3. Primary completion12 Jun 2024
  4. Study completion12 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128162
Sponsor's protocol ID
HUM00208367
Status last verified
Mar 2025
First submitted
14 Oct 2021
Last updated
16 Apr 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40171515

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin and Psychotherapy in people with Fibromyalgia, run by Kevin Boehnke at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) (time frame: Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128162, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

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