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Dextromethorphan in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring Fibromyalgia

Eligibility Criteria

23 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dextromethorphan

Placebo

Arm Description

Participant will take one dextromethorphan 10mg capsule in the morning and at night.

Participants will take one placebo capsule in the morning and at night.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 19, 2018
Last Updated
August 3, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03538054
Brief Title
Dextromethorphan in Fibromyalgia
Official Title
Dextromethorphan in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
The participant will not know when they are taking placebo or the study medication.
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextromethorphan
Arm Type
Experimental
Arm Description
Participant will take one dextromethorphan 10mg capsule in the morning and at night.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take one placebo capsule in the morning and at night.
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
(1)10 mg, by mouth, twice daily every 12 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule, by mouth, twice daily every 12 hours.
Primary Outcome Measure Information:
Title
Daily Self-reported Pain Severity
Description
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.
Time Frame
Daily over 4 weeks
Secondary Outcome Measure Information:
Title
Daily Self-reported Physical Activity
Description
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.
Time Frame
Daily over 4 weeks
Title
Patient Global Impression of Change
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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; 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarred W Younger, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama of Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dextromethorphan in Fibromyalgia

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