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Psilocybin-facilitated Treatment for Chronic Pain

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ClinicalTrials.gov Identifier: NCT05068791
Recruitment Status : Not yet recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Peter Hendricks, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia, Primary Drug: Psilocybin Drug: Dextromethorphan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a double-blind, placebo- controlled clinical trial.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Psilocybin-facilitated Treatment for Chronic Pain
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin
Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.
Drug: Psilocybin
0.36 mg/kg will be administered orally to participants

Active Comparator: Active Placebo
Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).
Drug: Dextromethorphan
2.6 mg/kg of active placebo will be administered orally to participants




Primary Outcome Measures :
  1. Change in daily self-reported pain severity [ Time Frame: through study completion, up to 13 weeks ]
    Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) [ Time Frame: through study completion, up to 13 weeks ]
    The PGIC is a single-item Likert scale with seven response options from 1 ('very much improved') to 7 ('very much worse').

  2. Change in self-reported pain severity (Brief Pain Inventory [BPI]) [ Time Frame: through study completion, up to 13 weeks ]
    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

  3. Change in self-reported pain interference (Brief Pain Inventory [BPI]) [ Time Frame: through study completion, up to 13 weeks ]
    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.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 25-65, inclusive;
  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 the last use of a hallucinogen
  8. 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.

Exclusion Criteria:

  1. Males;
  2. Opioid use;
  3. 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
  4. Regular use of any anti-inflammatory medication (e.g. aspirin, ibuprofen, naproxen,)
  5. Use of blood-thinning medications
  6. Daily consumption of grapefruit juice
  7. Febrile illness or use of antibiotics in the 4 weeks before study commencement;
  8. Vaccinated in the 4 weeks before study
  9. Current participation in another treatment trial
  10. Planned vaccination during the study period
  11. Planning to move from Birmingham area in the next 6 months
  12. Pregnant or planning to become pregnant within 6 months or currently breastfeeding
  13. Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of greater than or equal to 16
  14. First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders;
  15. Current suicidal or homicidal ideation; current or past history of any psychotic disorders; current or past history of bipolar I or II disorder
  16. Diagnosed rheumatologic or auto-immune condition;
  17. Blood or clotting disorder;
  18. Current hypertension (exceeding 140 systolic and 90 diastolic at resting);
  19. Acute infection (oral temperature >100°F);
  20. High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L;
  21. Eryhtrocyte sedimentation rate (ESR) >60 mm/hr
  22. Positive rheumatoid factor
  23. Positive anti-nuclear antibody (ANA) test
  24. levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs Reference values

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068791


Contacts
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Contact: Peter Hendricks, Ph.D. 205-202-1387 phendricks@uab.edu
Contact: Kathleen Hodgin, M.S. 205-934-8723 kathleenhodgin@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Peter Hendricks, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05068791    
Other Study ID Numbers: IRB-300006769
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Hendricks, University of Alabama at Birmingham:
psilocybin
fibromyalgia
pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Dextromethorphan
Psilocybin
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs