FibromyalgiaPhase 4LDN-in-FMNCT02806440
Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism?
A Phase 4 study testing Low dose naltrexone in people with Fibromyalgia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study. The study takes place at The Multidisciplinary Pain Center in Grindsted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Low dose naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Widespread pain in patients with fibromyalgia (based on the above criteria)
- Enrolled as a patient in one of the multidisciplinary pain clinics involved in the project
- Inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be excluded
- Women must be treated with a contraceptive measure, if not menopausal
Who cannot join
- Cancer
- Treatment with opioids (other analgesic treatments in stabile dose 14 days prior to study start are allowed)
- Change in stabile treatment (p.n. paracetamol is allowed, but must be registered)
- Pregnant/breastfeeding
- Does not speak/understand Danish
- Allergy to the ingredient
Show all 9Show fewer
- Severe liver impairment
- Severe kidney impairment
- Acute hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism? A Randomized, Double-blinded, Placebo-controlled, Crossover Study.
This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study.
The study takes place at The Multidisciplinary Pain Center in Grindsted.
Read the detailed description
Fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. The prevalence is estimated to be 2-8%.
Treatment of pain in patients with fibromyalgia is often based on opioids. However, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted.
Low dose naltrexone (3-5mg) (LDN) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research.
At the typical dose of naltrexone, 50 mg, it is an opioid antagonist. However LDN demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the CNS.
The investigators hypothesize, that LDN has a better pain relieving effect than placebo in in patients with fibromyalgia (FM). The investigators also hypothesize that LDN has a better effect upon experimentally induced pain in FM-patients, compared to placebo. A tentative mechanism is a central facilitation of the endogenous pain inbitory system.
- Conditions
- Fibromyalgia
- Being tested
- Low dose naltrexone, Placebo
- Keywords
- Low dose naltrexone, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose naltrexoneDrug
Also called Naltrexone
Active comparator
PlaceboDrug
Also called Inert substance
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Low dose naltrexone | Active comparator | Low dose naltrexone 4.5 mg/tablet, 1 tablet a day for 21 days Receives: Drug: Low dose naltrexone |
| Placebo | Placebo comparator | Placebo tablet
1 tablet a day for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)
The patient indicates using a questionnaire-based numerical rating scale (0 = no pain; 100 = worst imaginable pain) mean values of pain at rest, pain during household activity and pain during personal hygienic procedures in the preceding 24 hrs. The cumulated pain scores are used in the statistical analyses.
Measured: Baseline: Day -2 to day 1 (baseline before treatment 1); Treatment 1: Day 19 to 21 ; Washout: Day 33 to 35 (baseline before treatment 2); Treatment 2: Day 54 to 56
Secondary outcomes (10)
Fibromyalgia Impact Questionnaire Revised (FIQR)
The FIQR is a fibromyalgia-specific questionnaire containing three domains: function domain, impact domain and symptom domain. The total score of FIQR is calculated by:
- the function domain sum is divided by 3 (upper limit 30)
- the impact domain sum is unchanged (upper limit 20)
- the symptom domain sum is divided by 2 (upper limit 50) The three resulting processed domain scores are summed to obtain the total score of the FIQR (range 0-100)
Measured: Before baseline: Day -3; Treatment 1: Baseline (Day 1) + Day 14 + 21 ; Washout: Before baseline day -3; Treatment 2: Baseline (Day 35) + Day 49 + 56
Daily Sleep Interference Scale (DSIS)
Pain-related sleep interference is evaluated with the DSIS (0 =pain does not interfere with sleep, 10 = pain completely interferes with sleep]).
Measured: Diary (Treatment 1: baseline (Day 1) to Day 21; Treatment 2: baseline (Day 35) to Day 56)
Pressure algometry (1 sq.cm probe)
Pressure algometry in pre-specified points:
- right occipital region at insertion of m. subocipitalis
- right m. trapezius at the midpoint of the upper border
- right paraspinal region, 3 cm lateral of the midline at level of mid-scapula
- right second costochondral junction
- right lateral epicondyle
- right knee region, at the medial "fat pad" proximal of the meniscus margin
In addition at following control sites:
- right lower arm, at the dorsal lower third
- right fingernail of first digit
- right third metatarsal bone at midpoint Cut-off point is 400 kPa, rate 10-30 kPa/s
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item questionnaire used to evaluate the subject's level of anxiety and depression; the subjects can rate between 0-21 with a score of eleven as the cutoff point for anxiety or depression
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-report scale to measure pain catastrophizing: each item is rated on a 5-point nominal scale (0 = not at all, 4 = all the time). It is constructed with three subscales being magnification, rumination, and helplessness.
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Adverse effects
Self-reported adverse effects related to the treatment:
CNS: irritability, mood changes, drowsiness, lethargy, sleep dysfunction, dizziness cardiovascular system: palpitations, orthostatic hypotension g.i.-system: dyspepsia, nausea, obstipation, diarrhoea urogenital system: urinary retention, urinary incontinence autonomic system: diaphoresis, shivering
Measured: Diary + Treatment 1: Baseline (day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Quantitative Sensory Testing (QST)
Cold pressor test (1min, 10C) - Pressure tolerance threshold before and after Cold Water.
Heat/Capsaicin test - 5min, 45C heat, followed by 30min capsaicin cream 0.075%, Measurement of allodynic (brush, Somedic) and hyperalgesic (Pinprick stimulator 128nm) areas.
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Plasma concentrations of naltrexone and β-Naltrexon
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Pain DETECT
Measurement of neuropathic component
Measured: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Brief Pain Inventory - Short Form (BPI-SF) questionnaire
BPI-SF allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.
BPI-SF is a widely used Measurement Tool for assessing clinical pain.
Measured: Before baseline: Day -3 to -1; Washout: Before baseline Day 32 to 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion1 Dec 2019
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Werner, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten M Bested, MD, Principal investigator, Multidisciplinary Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806440
- Sponsor's protocol ID
- 2015-002972-26
- Other IDs
- 2015
- Acronym
- LDN-in-FM
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2016
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized IPD will be made available in a public research database as part of the final publication.
Publications
Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
PubMed 22607834Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
PubMed 24737367Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Gilron I, Jensen TS, Dickenson AH. Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurol. 2013 Nov;12(11):1084-95. doi: 10.1016/S1474-4422(13)70193-5. Epub 2013 Sep 25.
PubMed 24074723Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.
PubMed 24526250Younger JW, Zautra AJ, Cummins ET. Effects of naltrexone on pain sensitivity and mood in fibromyalgia: no evidence for endogenous opioid pathophysiology. PLoS One. 2009;4(4):e5180. doi: 10.1371/journal.pone.0005180. Epub 2009 Apr 13.
PubMed 19365548Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.
PubMed 23359310
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism? A Randomized, Double-blinded, Placebo-controlled, Crossover Study.
- ClinicalTrials.gov ID
- NCT02806440
- Acronym / sponsor ID
- LDN-in-FM / 2015-002972-26
- Conditions
- Fibromyalgia
- Keywords
- Low dose naltrexone, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study.
The study takes place at The Multidisciplinary Pain Center in Grindsted.
Detailed description
Fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. The prevalence is estimated to be 2-8%.
Treatment of pain in patients with fibromyalgia is often based on opioids. However, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted.
Low dose naltrexone (3-5mg) (LDN) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research.
At the typical dose of naltrexone, 50 mg, it is an opioid antagonist. However LDN demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the CNS.
The investigators hypothesize, that LDN has a better pain relieving effect than placebo in in patients with fibromyalgia (FM). The investigators also hypothesize that LDN has a better effect upon experimentally induced pain in FM-patients, compared to placebo. A tentative mechanism is a central facilitation of the endogenous pain inbitory system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose naltrexone | Active comparator | Drug: Low dose naltrexoneLow dose naltrexone 4.5 mg/tablet, 1 tablet a day for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet 1 tablet a day for 21 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Widespread pain in patients with fibromyalgia (based on the above criteria)
- Enrolled as a patient in one of the multidisciplinary pain clinics involved in the project
- Inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be excluded
- Women must be treated with a contraceptive measure, if not menopausal
Key exclusion criteria (9 listed)
- Cancer
- Treatment with opioids (other analgesic treatments in stabile dose 14 days prior to study start are allowed)
- Change in stabile treatment (p.n. paracetamol is allowed, but must be registered)
- Pregnant/breastfeeding
- Does not speak/understand Danish
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 |
|---|---|---|
| Low dose naltrexoneAlso: NaltrexoneActive comparator | Drug | Low dose naltrexone |
| PlaceboAlso: Inert substancePlacebo comparator | Drug | Placebo |
Primary outcome
Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)
Time frame: Baseline: Day -2 to day 1 (baseline before treatment 1); Treatment 1: Day 19 to 21 ; Washout: Day 33 to 35 (baseline before treatment 2); Treatment 2: Day 54 to 56
The patient indicates using a questionnaire-based numerical rating scale (0 = no pain; 100 = worst imaginable pain) mean values of pain at rest, pain during household activity and pain during personal hygienic procedures in the preceding 24 hrs. The cumulated pain scores are used in the statistical analyses.
10 secondary outcomes
Fibromyalgia Impact Questionnaire Revised (FIQR)
Time frame: Before baseline: Day -3; Treatment 1: Baseline (Day 1) + Day 14 + 21 ; Washout: Before baseline day -3; Treatment 2: Baseline (Day 35) + Day 49 + 56
Daily Sleep Interference Scale (DSIS)
Time frame: Diary (Treatment 1: baseline (Day 1) to Day 21; Treatment 2: baseline (Day 35) to Day 56)
Pressure algometry (1 sq.cm probe)
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Hospital Anxiety and Depression Scale (HADS)
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Pain Catastrophizing Scale (PCS)
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Adverse effects
Time frame: Diary + Treatment 1: Baseline (day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Quantitative Sensory Testing (QST)
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Plasma concentrations of naltrexone and β-Naltrexon
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Pain DETECT
Time frame: Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56
Brief Pain Inventory - Short Form (BPI-SF) questionnaire
Time frame: Before baseline: Day -3 to -1; Washout: Before baseline Day 32 to 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 22607834Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
- Background: PubMed 24737367Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
- Background: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Background: PubMed 24074723Gilron I, Jensen TS, Dickenson AH. Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurol. 2013 Nov;12(11):1084-95. doi: 10.1016/S1474-4422(13)70193-5. Epub 2013 Sep 25.
- Background: PubMed 24526250Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.
- Results publication: PubMed 19365548Younger JW, Zautra AJ, Cummins ET. Effects of naltrexone on pain sensitivity and mood in fibromyalgia: no evidence for endogenous opioid pathophysiology. PLoS One. 2009;4(4):e5180. doi: 10.1371/journal.pone.0005180. Epub 2009 Apr 13.
- Results publication: PubMed 23359310Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.
- Individual participant dataSharing planned: Yes. Anonymized IPD will be made available in a public research database as part of the final publication.
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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.
Kirsten M Bested, MD principal investigator
Multidisciplinary Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose naltrexone in people with Fibromyalgia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 9 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 23 Feb 2024. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain scores (during rest, during household activity, during personal daily hygienic procedures) (time frame: Baseline: Day -2 to day 1 (baseline before treatment 1); Treatment 1: Day 19 to 21 ; Washout: Day 33 to 35 (baseline before treatment 2); Treatment 2: Day 54 to 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806440, which also lists 7 linked publications.
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 23 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.