Psilocybin-facilitated Treatment for Chronic Pain
ConditionFibromyalgia, Primary
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Psilocybin
- Dextromethorphan
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
1UAB Beacon Tower35209, BirminghamAlabama, United States
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Source ClinicalTrials.gov