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

Phase 2

Completed

Conditions: Fibromyalgia

Interventions: Drug: Psilocybin
Behavioral: Psychotherapy

Registration Number: NCT05128162

Lead Sponsor: Kevin Boehnke

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Oral Psilocybin	Psilocybin	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.
Open Label Oral Psilocybin	Psychotherapy	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure (BP) - First Dose (15 mg) - Systolic	Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	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.
Blood Pressure (BP) - Second Dose (25 mg) - Systolic	Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	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.
Blood Pressure (BP) - First Dose (15 mg) - Diastolic	Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	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.
Adverse Events (AE) Incidence	Day 1 through Day 64	Results reflect the total number of all adverse events that occurred during the trial.
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg)	Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg)	Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic	Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Disturbance	Day 1 and Day 64	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.
Chronic Pain Acceptance	Day 1 and Day 64	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).
Patient Global Impression of Change (PGI-C)	Day 64	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".
Change in Pain Interference	Day 1 and Day 64	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.
Chronic Pain Intensity Between Groups in the Study Period	Days 1-7 & Days 57-63	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.