RECRUITING

Psilocybin-facilitated Treatment for Chronic Pain

Conditions

Fibromyalgia, Primary psilocybin fibromyalgia pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Psilocybin-facilitated Treatment for Chronic Pain

Quick Facts

Study Start:2023-11-01

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05068791

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Peter Hendricks, Ph.D.

CONTACT

205-202-1387

phendricks@uab.edu

Study Locations (Sites)

UAB Beacon Tower

Birmingham, Alabama, 35209

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

psilocybin
fibromyalgia
pain

Additional Relevant MeSH Terms

Fibromyalgia, Primary