Psilocybin-facilitated Treatment for Chronic Pain
University of Alabama at Birmingham
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.
Description
Participants will be randomized to two groups: Psilocybin or Active Placebo. Those in the Psilocybin condition will receive .36 mg/kg of psilocybin. Based on previous research, .36 mg/kg of psilocybin is expected to balance the intention to increase the probability of having a full mystical-type experience against the odds of having a subjectively challenging psychological experience. Those in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). DXM was selected as the placebo drug in the current study because its subjective and behavioral effects at higher doses can…
Eligibility
- Age range
- 25–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Female age 25-65; 2. Widespread musculoskeletal pain for ≥12 months; 3. Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria; 4. Participant completes daily report during baseline period (at least 80% completion rate); 5. Able to attend UAB for all scheduled appointments; 6. Ability to read/write in English; 7. No prior hallucinogen use or it will have been at least 3 years since last use of a hallucinogen; 8. Availability of a friend or family member into whose care the participant can be released…
Interventions
- DrugPsilocybin
0.36 mg/kg will be administered orally to participants
- DrugDextromethorphan
2.6 mg/kg of active placebo will be administered orally to participants
Location
- UAB Beacon TowerBirmingham, Alabama