Phase 2
N=19
Dextromethorphan in Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT03538054 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Daily Self-reported Pain Severity — 41.09; 45.55 score/day — p=0.146
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dextromethorphan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Self-reported Pain Severity |
41.09; 45.55 | 0.146 |
| SECONDARY Daily Self-reported Physical Activity |
46.92; 50.10 | 0.052 |
| SECONDARY Patient Global Impression of Change |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
- Daily self-reported pain of at least 4 out of 10;
- Meets American College of Rheumatology 2016 case definition criteria for FM;
- Able to attend UAB for all scheduled appointments;
- Can complete daily self-reports of pain and other symptoms for duration of project.
Exclusion Criteria
- Blood draw contraindicated or otherwise not able to be performed;
- High-sensitivity C-reactive protein (HS-CRP) ≥ 10 mg/L;
- Erythrocyte sedimentation rate (ESR) >60 mm/hr;
- Positive rheumatoid factor;
- Positive anti-nuclear antibody (ANA);
- Abnormal thyroid stimulating hormone or free thyroxine;
- Diagnosed rheumatologic or auto-immune condition;
- Blood or clotting disorder;
- Use of blood thinning medication;
- Current use of MAOI
- Daily consumption of grapefruit juice
- Oral temperature >100˚F at baseline;
- Febrile illness or use of antibiotics in the 4 weeks before study commencement;
- Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement;
- Pregnant or planning on becoming pregnant within 6 months, or currently breastfeeding
- Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen);
- Baseline HADS (Hospital Anxiety and Depression Scale) depression subscale score of ≥16;
- Current litigation or worker's compensation claim;
- Current participation in another treatment trial;
- Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement.
Data sourced from ClinicalTrials.gov (NCT03538054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.