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Psilocybin-facilitated Treatment for Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05068791
Recruitment Status : Not yet recruiting
First Posted : October 6, 2021
Last Update Posted : October 3, 2022
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 Early Phase 1

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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psilocybin-facilitated Treatment for Chronic Pain
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024


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. 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 (a key responsibility includes driving participants home) following their drug administration session;
  9. A current average daily pain score of at least 5 on a 0-10 scale;
  10. Discontinuation of exclusionary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day.

Exclusion Criteria:

  1. Males;
  2. Use of opioid medications in the last 60 days;
  3. Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen);
  4. Use of blood thinning medication;
  5. 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;
  6. Daily consumption of grapefruit juice;
  7. Febrile illness or use of antibiotics in the 4 weeks before study commencement;
  8. Planned surgery or procedures during the study period, or operated on in the 4 weeks prior to study commencement;
  9. Planning to move from the Birmingham area in the next 6 months;
  10. Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement;
  11. Current participation in another treatment trial;
  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 (i.e., presence of a current, clinically significant, untreated or unstable psychiatric condition) and/or a baseline HADS depression subscale score of ≥16;
  14. Current or past history of any psychotic disorders;
  15. Current or past history of bipolar I or II disorder;
  16. First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders;
  17. Current suicidal or homicidal ideation (assessed using Columbia-Suicide Severity Rating Scale at each visit);
  18. Diagnosed rheumatologic or auto-immune condition;
  19. Blood or clotting disorder;
  20. Current hypertension (exceeding 140 systolic or 90 diastolic at resting); resting heart rate>90
  21. Acute infection (oral temperature >100°F);
  22. High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L;
  23. Erythrocyte sedimentation rate (ESR) > 60 mm/hr;
  24. Positive rheumatoid factor;
  25. Positive anti-nuclear antibody (ANA);
  26. Levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs reference values;
  27. Use of UGT1A9, UGT1A10 and aldehyde or alcohol dehydrogenase enzyme inhibitors;
  28. Dependent on any psychoactive drugs other than nicotine and caffeine;
  29. Use of the antiviral drug efavirenz;
  30. Use of PDE-5-Inhibitors, soluble guanylate cyclase (sGC) stimulators;
  31. Severe anemia;
  32. Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, and mucus with cough or slowed breathing
  33. Use of any medication containing dextromethorphan (e.g., cough suppressants);
  34. Pain due to other conditions or diseases that would complicate study participation or pain reporting.
  35. Use of strong or moderate inhibitors of Cytochrome P450 2D6 (CYP2D6)
  36. Poor metabolizers of CYP2D6 based on genotype

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.A. 205-2862157 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 3, 2022
Last Verified: September 2022

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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