Psilocybin-facilitated Treatment for Chronic Pain (NCT05068791) | Clinical Trial Compass
RecruitingEarly Phase 1
Psilocybin-facilitated Treatment for Chronic Pain
United States30 participantsStarted 2023-11-01
Plain-language summary
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female age 25-65;
. Widespread musculoskeletal pain for ≥12 months;
. Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria;
. Participant completes daily report during baseline period (at least 80% completion rate);
. Able to attend UAB for all scheduled appointments;
. Ability to read/write in English;
. No prior hallucinogen use or it will have been at least 3 years since last use of a hallucinogen;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in daily self-reported pain severity
Timeframe: through study completion, up to 13 weeks
. Availability of a friend or family member into whose care the participant can be released (a key responsibility includes driving participants home) following their drug administration session;
Exclusion criteria
. Males;
. Use of opioid medications in the last 60 days;
. Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen);
. Use of blood thinning medication;
. Use of tricyclic antidepressants, lithium, SSRIs, MAOIs, St. John's Wort, 5-hydroxytryptophan (5-HT), haloperidol, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity;
. Daily consumption of grapefruit juice;
. Febrile illness or use of antibiotics in the 4 weeks before study commencement;
. Planned surgery or procedures during the study period, or operated on in the 4 weeks prior to study commencement;