Trial Outcomes & Findings for Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia (NCT NCT05128162)

Last Updated: 2025-04-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

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

Results posted on

2025-04-16

Participant Flow

17 participants were consented for this trial, 10 of whom were screen fails. Of the 7 remaining participants, 5 received the intervention and completed the trial.

Participant milestones

Participant milestones
Measure	Open Label Dosing Arm (15mg and 25mg) 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Overall Study STARTED	7
Overall Study Received 15 mg Dose (Day 22)	5
Overall Study Received Second 15 mg Dose (Day 36)	1
Overall Study Received 25 mg Dose (Day 36)	4
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Dosing Arm (15mg and 25mg) 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Overall Study Concerns about participant ability to follow study procedures	1
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Dosing Arm (15mg and 25mg) n=17 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Age, Continuous	45.06 years STANDARD_DEVIATION 14.41 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

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

Population: Results reflect the participants who completed the trial.

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

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) Baseline (before capsule administration)	76 Heart beats per minute Interval 64.0 to 85.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 30 minutes after capsule administration	67 Heart beats per minute Interval 59.0 to 81.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 60 minutes after capsule administration	67 Heart beats per minute Interval 61.0 to 83.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 90 minutes after capsule administration	68 Heart beats per minute Interval 61.0 to 88.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 120 minutes after capsule administration	74 Heart beats per minute Interval 65.0 to 87.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 180 minutes after capsule administration	83 Heart beats per minute Interval 63.0 to 87.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 240 minutes after capsule administration	79 Heart beats per minute Interval 67.0 to 94.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 300 minutes after capsule administration	82 Heart beats per minute Interval 75.0 to 88.0
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg) 360 minutes after capsule administration	72 Heart beats per minute Interval 71.0 to 87.0

PRIMARY outcome

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

Population: Results reflect the participants who completed the trial. 1 participant elected to take a second 15 mg dose rather than the 25 mg dose. That participant's data was included in the results for this outcome.

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

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) Baseline (before capsule administration)	75 Heart beats per minute Interval 70.0 to 95.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 30 minutes after capsule administration	85 Heart beats per minute Interval 57.0 to 88.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 60 minutes after capsule administration	82 Heart beats per minute Interval 57.0 to 90.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 90 minutes after capsule administration	80 Heart beats per minute Interval 56.0 to 86.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 120 minutes after capsule administration	80 Heart beats per minute Interval 56.0 to 88.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 180 minutes after capsule administration	75 Heart beats per minute Interval 60.0 to 101.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 240 minutes after capsule administration	80 Heart beats per minute Interval 62.0 to 106.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 300 minutes after capsule administration	86 Heart beats per minute Interval 64.0 to 115.0
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg) 360 minutes after capsule administration	76 Heart beats per minute Interval 61.0 to 106.0

PRIMARY outcome

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

Population: Results reflect the participants who completed the trial.

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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Blood Pressure (BP) - First Dose (15 mg) - Systolic Baseline (before capsule administration)	133 mm Hg Interval 122.0 to 141.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 30 minutes after capsule administration	126 mm Hg Interval 110.0 to 139.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 60 minutes after capsule administration	131 mm Hg Interval 124.0 to 159.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 90 minutes after capsule administration	137 mm Hg Interval 124.0 to 145.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 120 minutes after capsule administration	131 mm Hg Interval 121.0 to 181.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 180 minutes after capsule administration	141 mm Hg Interval 120.0 to 147.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 240 minutes after capsule administration	130 mm Hg Interval 119.0 to 143.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 300 minutes after capsule administration	128 mm Hg Interval 113.0 to 166.0
Blood Pressure (BP) - First Dose (15 mg) - Systolic 360 minutes after capsule administration	135 mm Hg Interval 125.0 to 154.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Blood Pressure (BP) - Second Dose (25 mg) - Systolic Baseline (before capsule administration)	135 mm Hg Interval 114.0 to 147.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 30 minutes after capsule administration	123 mm Hg Interval 112.0 to 167.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 60 minutes after capsule administration	140 mm Hg Interval 117.0 to 183.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 90 minutes after capsule administration	141 mm Hg Interval 106.0 to 180.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 120 minutes after capsule administration	127 mm Hg Interval 114.0 to 171.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 180 minutes after capsule administration	142 mm Hg Interval 126.0 to 178.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 240 minutes after capsule administration	134 mm Hg Interval 116.0 to 151.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 300 minutes after capsule administration	134 mm Hg Interval 128.0 to 141.0
Blood Pressure (BP) - Second Dose (25 mg) - Systolic 360 minutes after capsule administration	141 mm Hg Interval 108.0 to 151.0

PRIMARY outcome

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

Population: Results reflect the participants who completed the trial.

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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Blood Pressure (BP) - First Dose (15 mg) - Diastolic Baseline (before capsule administration)	81 mm Hg Interval 64.0 to 85.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 30 minutes after capsule administration	76 mm Hg Interval 68.0 to 78.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 60 minutes after capsule administration	74 mm Hg Interval 64.0 to 79.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 90 minutes after capsule administration	75 mm Hg Interval 68.0 to 87.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 120 minutes after capsule administration	75 mm Hg Interval 67.0 to 86.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 180 minutes after capsule administration	78 mm Hg Interval 67.0 to 80.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 240 minutes after capsule administration	64 mm Hg Interval 62.0 to 81.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 300 minutes after capsule administration	67 mm Hg Interval 61.0 to 80.0
Blood Pressure (BP) - First Dose (15 mg) - Diastolic 360 minutes after capsule administration	84 mm Hg Interval 72.0 to 86.0

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic Baseline (before capsule administration)	82 mm Hg Interval 70.0 to 95.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 30 minutes after capsule administration	65 mm Hg Interval 64.0 to 79.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 60 minutes after capsule administration	74 mm Hg Interval 61.0 to 87.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 90 minutes after capsule administration	74 mm Hg Interval 59.0 to 82.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 120 minutes after capsule administration	70 mm Hg Interval 56.0 to 83.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 180 minutes after capsule administration	78 mm Hg Interval 64.0 to 83.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 240 minutes after capsule administration	80 mm Hg Interval 70.0 to 81.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 300 minutes after capsule administration	69 mm Hg Interval 63.0 to 88.0
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic 360 minutes after capsule administration	80 mm Hg Interval 55.0 to 92.0

PRIMARY outcome

Timeframe: Day 1 through Day 64

Population: Results reflect the participants who completed the trial.

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

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Adverse Events (AE) Incidence	20 Adverse Events

SECONDARY outcome

Timeframe: Day 1 and Day 64

Population: Results reflect the participants who completed the trial.

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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Change in Pain Interference Pre capsule administration (Day 1)	62.5 t-score Interval 57.1 to 66.6
Change in Pain Interference Post capsule administration (Day 64)	53.1 t-score Interval 41.6 to 57.1

SECONDARY outcome

Timeframe: Day 1 and Day 64

Population: Results reflect the participants who completed the trial.

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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Sleep Disturbance Pre capsule administration (Day 1)	58.2 t-score Interval 50.1 to 62.6
Sleep Disturbance Post capsule administration (Day 64)	51.1 t-score Interval 47.9 to 55.3

SECONDARY outcome

Timeframe: Day 1 and Day 64

Population: Results reflect the participants who completed the trial.

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).

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Chronic Pain Acceptance Pre capsule administration (Day 1)	28.4 score on a scale Interval 23.0 to 31.0
Chronic Pain Acceptance Post capsule administration (Day 64)	30.4 score on a scale Interval 26.0 to 35.0

SECONDARY outcome

Timeframe: Day 64

Population: Results reflect the participants who completed the trial.

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".

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Patient Global Impression of Change (PGI-C)	2 Score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Days 1-7 & Days 57-63

Population: Results reflect the participants who completed the trial.

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.

Outcome measures

Outcome measures
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 Participants 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. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
Chronic Pain Intensity Between Groups in the Study Period Days 1-7	4.9 score on a scale Interval 3.7 to 5.9
Chronic Pain Intensity Between Groups in the Study Period Days 57-63	2.5 score on a scale Interval 1.1 to 2.7

Adverse Events

Open Label Dosing Arm (15mg and 25mg)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Dosing Arm (15mg and 25mg) n=5 participants at risk Enrolled participants received 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a second dose, which was planned to be 25 mg. 1 participant elected the second dose to be 15 mg instead. The total planned duration of the study for an individual participant from screening through pre-dose preparatory sessions to last follow-up was approximately 8 months. Psilocybin: Two oral doses of psilocybin in a capsule formulation taken approximately 2 weeks apart. Psychotherapy: 1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and 3. Post-dose integration sessions.
Endocrine disorders Fatigue (Pre-Dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Gastrointestinal disorders Diarrhea (following 15 mg dose)	40.0% 2/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Gastrointestinal disorders Diarrhea (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Gastrointestinal disorders Stomach Ache (following 15 mg dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Gastrointestinal disorders Vomiting (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
General disorders Sore Throat (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Back Ache (Pre-Dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Back Ache (following 15 mg dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Body Aches (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Jaw Pain (temporomandibular joint dysfunction [TMJ]) (Pre-dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Leg Throbbing (following 15 mg dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Tight Left Side of Neck (Pre-Dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Musculoskeletal and connective tissue disorders Tight Left Side of Neck (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Chills (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Fever (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Headache (Following 15 mg dose)	60.0% 3/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Headache (Pre-Dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Headache (following 25 mg dose)	75.0% 3/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Nervous system disorders Migraine (following 15 mg dose)	20.0% 1/5 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.
Respiratory, thoracic and mediastinal disorders Sinus Pressure (following 25 mg dose)	25.0% 1/4 • Up to 8 months Results reflect the participants who received the intervention and completed the trial. As shown in the milestones under the Participant Flow, 1 participant did not receive the 25 mg dose and opted to receive a second 15 mg dose. Therefore, that participant is not included in the denominators for AEs involving the 25 mg dose.

Additional Information

Kevin Boehnke, PhD

University of Michigan

Phone: 734-998-6939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place