Psilocybin-facilitated Treatment for Chronic Pain

Who is this study for? Patients with Fibromyalgia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• 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;

• 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;

• A current average daily pain score of at least 5 on a 0-10 scale;

⁃ Discontinuation of exclusionary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day.

Locations
United States
Alabama
UAB Beacon Tower
RECRUITING
Birmingham
Contact Information
Primary
Peter Hendricks, Ph.D.
phendricks@uab.edu
205-202-1387
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 30
Treatments
Experimental: Psilocybin
Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.
Active_comparator: Active Placebo
Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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