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Dextromethorphan in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03538054
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Jarred Younger, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE June 26, 2018
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Daily self-reported pain severity [ Time Frame: For the primary test of efficacy, average pain over the final 4 weeks of DXM condition contrasted with final 4 weeks of placebo condition. ]
The primary outcome will be daily self-reported widespread pain severity, rated on a 0 - 100 scale (100 = worst pain possible).
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Daily self-reported pain severity [ Time Frame: The goal for completion would be within 1 year after the study has ended. ]
The primary outcome will be daily self-reported widespread pain severity, rated on a 0 - 100 scale (100 = worst pain possible). For the primary test of efficacy, average pain over the final 4 weeks of DXM condition contrasted with final 4 weeks of placebo condition.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Daily self-reported physical activity [ Time Frame: Test of efficacy will use average activity over the final 4 weeks of the DXM condition contrasted with final 4 weeks of placebo condition. ]
    Secondary outcome #1 is self-reported daily activity, rated from 0 - 100.
  • Patient global impression of change [ Time Frame: Over the 20-week placebo and DXM periods, we will contrast PGIC rating provided at the end of the placebo condition with PGIC rating provided at the end of the DXM condition. ]
    Secondary outcome #2 is the patient global impression of change (PGIC) measured in a seven point likert scale (from no change to a great deal better).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Daily self-reported activity [ Time Frame: The goal for completion would be within 1 year after the study has ended. ]
    Secondary outcome #1 is self-reported daily activity, rated from 0 - 100. Test of efficacy will use average activity over the final 4 weeks of the DXM condition contrasted with final 4 weeks of placebo condition.
  • Patient global impression of change of quality of life and symptoms [ Time Frame: The goal for completion would be within 1 year after the study has ended. ]
    Secondary outcome #2 is the patient global impression of change (PGIC) measured in a seven point likert scale (from no change to a great deal better) in the final visit of the DXM condition contrasted with the final visit of the placebo condition.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dextromethorphan in Fibromyalgia
Official Title  ICMJE Dextromethorphan in Fibromyalgia
Brief 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.
Detailed Description

Fibromyalgia (FM) is a chronic, widespread pain syndrome. Individuals with FM frequently report body pain, fatigue, sleep issues, cognitive impairment, headaches, and other symptoms. The disease affects approximately 5% of women in the United States. Many of those patients suffer with decreased quality of life and loss of employment.

The precise pathological mechanism of FM is not yet understood, and there is no targeted treatment for the condition. One hypothesis of FM with prior scientific support is that pain is caused by abnormal inflammation of the brain. When microglia cells in the brain adopt an inflammatory state, they release chemicals that can cause neurons to increase the transmission of pain signals.

DXM has been used in previous research and demonstrated to suppress pain symptoms. When given at higher dosages (above 200mg), the medication acts as a dissociative agent. This dosage can reduce pain, but produces side-effects that can limit daily functioning. At lower dosages, however, DXM may reduce inflammatory aspects of chronic pain while not causing dissociative side effects.

In animal models, central inflammation can be reduced with intraperitoneal dosages of DXM of 0.1mg/kg. In an average U.S. woman, this dosage would translate to approximately 8mg. Because an oral versus intraperitoneal dosing route will be used, the dose will be raised to 10mg, administered twice a day (once in the morning and once at night). The investigator will examine the impact of 20mg total daily DXM on self-reported FM pain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description:
The participant will not know when they are taking placebo or the study medication.
Primary Purpose: Other
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Dextromethorphan
    (1)10 mg, by mouth, twice daily every 12 hours.
  • Drug: Placebo
    1 capsule, by mouth, twice daily every 12 hours.
Study Arms  ICMJE
  • Experimental: Dextromethorphan
    Participant will take one dextromethorphan 10mg capsule in the morning and at night.
    Intervention: Drug: Dextromethorphan
  • Placebo Comparator: Placebo
    Participants will take one placebo capsule in the morning and at night.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 23 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538054
Other Study ID Numbers  ICMJE F161018005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jarred Younger, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jarred W Younger, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP