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Trial record 10 of 104 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Dextromethorphan in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03538054
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jarred Younger, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Dextromethorphan Drug: Placebo Phase 2

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 : Interventional
Estimated Enrollment : 15 participants
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
Official Title: Dextromethorphan in Fibromyalgia
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Dextromethorphan
Participant will take one dextromethorphan 10mg capsule in the morning and at night.
Drug: Dextromethorphan
(1)10 mg, by mouth, twice daily every 12 hours.

Placebo Comparator: Placebo
Participants will take one placebo capsule in the morning and at night.
Drug: Placebo
1 capsule, by mouth, twice daily every 12 hours.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538054


Contacts
Contact: Kate M Wesson Sides, BS 12566001662 cfs@uab.edu
Contact: Tammie Quinn, BS 2059755907 youngerlab@uab.edu

Locations
United States, Alabama
University of Alabama of Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kate M Wesson Sides, BS    205-975-5850    cfs@Uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jarred W Younger, PhD University of Alabama at Birmingham

Responsible Party: Jarred Younger, Associate Professor; Director of the Neuroinflammation, Pain and Fatigue Laboratory, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03538054     History of Changes
Other Study ID Numbers: F161018005
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jarred Younger, University of Alabama at Birmingham:
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs