FibromyalgiaPhase 2NCT03538054
Dextromethorphan in Fibromyalgia
A Phase 2 study testing Dextromethorphan in people with Fibromyalgia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 18 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama of Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Dextromethorphan, Placebo
- Keywords
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
(1)10 mg, by mouth, twice daily every 12 hours.
PlaceboDrug
1 capsule, by mouth, twice daily every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan | Experimental | Participant will take one dextromethorphan 10mg capsule in the morning and at night. Receives: Drug: Dextromethorphan |
| Placebo | Placebo comparator | Participants will take one placebo capsule in the morning and at night. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily over 4 weeks
Secondary outcomes (2)
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.
Measured: Daily over 4 weeks
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start26 Jun 2018
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarred Younger, University of Alabama at Birmingham
- Investigators
- Jarred W Younger, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538054
- Sponsor's protocol ID
- F161018005
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2018
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextromethorphan in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03538054
- Acronym / sponsor ID
- F161018005
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 26 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan | Experimental | Drug: DextromethorphanParticipant will take one dextromethorphan 10mg capsule in the morning and at night. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take one placebo capsule in the morning and at night. |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan(1)10 mg, by mouth, twice daily every 12 hours. | Drug | Dextromethorphan |
| Placebo1 capsule, by mouth, twice daily every 12 hours. | Drug | Placebo |
Primary outcome
Daily Self-reported Pain Severity
Time frame: Daily over 4 weeks
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.
2 secondary outcomes
Daily Self-reported Physical Activity
Time frame: Daily over 4 weeks
Patient Global Impression of Change
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarred W Younger, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextromethorphan in people with Fibromyalgia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Self-reported Pain Severity (time frame: Daily over 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.