Dextromethorphan in Fibromyalgia

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Dextromethorphan

Criteria

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.