Fibromyalgia Clinical Trial
Official title:
Dextromethorphan in Fibromyalgia
Verified date | August 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia (FM) pain. DXM is a drug found in several over-the-counter products, including cough suppressants. The drug may reduce FM pain by suppressing inflammation in the central nervous system. The investigators will be observing the effects of DXM on daily self-reported pain measures in people with FM. If DXM reduces FM pain, it will provide important information about the nature of FM pathophysiology.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 18, 2020 |
Est. primary completion date | March 18, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 23 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Severe chronic fatigue =6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue; 2. Daily self-reported pain of at least 4 out of 10; 3. Meets American College of Rheumatology 2016 case definition criteria for FM; 4. Able to attend UAB for all scheduled appointments; 5. Can complete daily self-reports of pain and other symptoms for duration of project. Exclusion Criteria: 1. Blood draw contraindicated or otherwise not able to be performed; 2. High-sensitivity C-reactive protein (HS-CRP) = 10 mg/L; 3. Erythrocyte sedimentation rate (ESR) >60 mm/hr; 4. Positive rheumatoid factor; 5. Positive anti-nuclear antibody (ANA); 6. Abnormal thyroid stimulating hormone or free thyroxine; 7. Diagnosed rheumatologic or auto-immune condition; 8. Blood or clotting disorder; 9. Use of blood thinning medication; 10. Current use of MAOI 11. Daily consumption of grapefruit juice 12. Oral temperature >100°F at baseline; 13. Febrile illness or use of antibiotics in the 4 weeks before study commencement; 14. Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement; 15. Pregnant or planning on becoming pregnant within 6 months, or currently breastfeeding 16. Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen); 17. Baseline HADS (Hospital Anxiety and Depression Scale) depression subscale score of =16; 18. Current litigation or worker's compensation claim; 19. Current participation in another treatment trial; 20. Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama of Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily Self-reported Pain Severity | Daily self-reported widespread pain severity, rated on a 0 - 100 scale (0 = no pain and 100 = worst pain possible). Participants' daily scores from the last 4 weeks of each condition (placebo and dextromethorphan) were summed and then averaged across the 4-week time period. | Daily over 4 weeks | |
Secondary | Daily Self-reported Physical Activity | Self-reported daily activity, rated from 0 - 100 where 0 is less daily activity and 100 is the most amount of daily activity. Participants' daily scores from the last 4 weeks of each condition (placebo and dextromethorphan) were summed and then averaged across the 4-week time period. | Daily over 4 weeks | |
Secondary | Patient Global Impression of Change | Patient global impression of change (PGIC) measured on a seven point likert scale (1 = "no change" to 7 = "a great deal better"). PGIC's were not administered to participants. The PGIC was inadvertently left out of the lab visit packet. Since the PGIC was not administered, data was not collected for both arms/groups. | 20 weeks |
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