Psilocybin-facilitated Treatment for Chronic Pain

NCT05068791 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300006769UAB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia, Primary

Keywords

psilocybin; fibromyalgia; pain

Outcome Measures

Primary Outcomes (1)

• Change in daily self-reported pain severity

  Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')

  through study completion, up to 13 weeks

Secondary Outcomes (3)

• Patient Global Impression of Change (PGIC)

  through study completion, up to 13 weeks

• Change in self-reported pain severity (Brief Pain Inventory [BPI])

  through study completion, up to 13 weeks

• Change in self-reported pain interference (Brief Pain Inventory [BPI])

  through study completion, up to 13 weeks

Study Arms (2)

Psilocybin

EXPERIMENTAL

Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.

Drug: Psilocybin

Active Placebo

ACTIVE COMPARATOR

Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).

Drug: Dextromethorphan

Interventions

Psilocybin DRUG

0.36 mg/kg will be administered orally to participants

Psilocybin

Dextromethorphan DRUG

2.6 mg/kg of active placebo will be administered orally to participants

Active Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Planning to move from the Birmingham area in the next 6 months;
• Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement;
• Current participation in another treatment trial;
• Pregnant or planning to become pregnant within 6 months, or currently breastfeeding;
• Significant psychological comorbidity that in the discretion of the investigator compromises study integrity (i.e., presence of a current, clinically significant, untreated or unstable psychiatric condition) and/or a baseline HADS depression subscale score of ≥16;
• Current or past history of any psychotic disorders;
• Current or past history of bipolar I or II disorder;

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Beacon Tower

Birmingham, Alabama, 35209, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Psilocybin; Dextromethorphan

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Peter Hendricks, Ph.D.

CONTACT

205-202-1387; phendricks@uab.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a double-blind, placebo- controlled clinical trial.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 6, 2021
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)