Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    0.36 mg/kg will be administered orally to participants

  • Dextromethorphan

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PsilocybinExperimental treatment 1 intervention
Group B: Active PlaceboActive comparator 1 intervention

Trial outcomes

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')

Time frame
through study completion, up to 13 weeks

Secondary outcomes

1

Patient Global Impression of Change (PGIC)

The PGIC is a single-item Likert scale with seven response options from 1 ('very much improved') to 7 ('very much worse').

Time frame
through study completion, up to 13 weeks
2

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

Pain severity scores will be calculated as a composite of the four pain severity items scored from 0 ('no pain') to 10 ('pain as bad as you can imagine') on the BPI

Time frame
through study completion, up to 13 weeks
3

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

Pain interference scores will be calculated as the mean of the seven pain interference items scored from 0 ('does not interfere') to 10 ('completely interferes') on the BPI.

Time frame
through study completion, up to 13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov
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