FibromyalgiaLDN-IMNCT02107014

Low Dose Naltrexone (LDN) Immune Monitoring

A study testing Low Dose Naltrexone in people with Fibromyalgia, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Fibromyalgia
What is being tested?: Low Dose Naltrexone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Jul 2014
Phase: Interventional
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 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Females age 18-65
Meets criteria for 1990 ACR criteria for fibromyalgia
Able to receive venous blood draw twice a week for 16 weeks
Sufficient symptom variability during baseline report
Patient completes daily report during 2 week baseline period at least 80% completion rate.

Who cannot join

Opioid use
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
Location prohibits travel to Stanford
Blood or clotting disorder
Rheumatologic or autoimmune disease
Acute infection

Show all 13Show fewer

Baseline blood ESR >60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA
Use of blood thinning medication
Pregnant or currently planning to become pregnant
Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.
Known allergy to Naltrexone or Naloxone
Currently participating in another treatment-based research study
Self-reported inability to refrain from alcohol for the duration of the study period

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Palo Alto, California, 94304

Other trials in United States

About this study

Read the detailed description

Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

Conditions: Fibromyalgia
Being tested: Low Dose Naltrexone
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low Dose NaltrexoneDrug
Also called LDN, Naltrexone
Naltrexone 4.5 mg p.o. nocte

Study groups in NCT02107014
Study group	Role	What they receive
Low Dose Naltrexone (LDN)	Other	Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period. Receives: Drug: Low Dose Naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in IL-1α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1Ra From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-2 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-4 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-5 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-6 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-7 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-8 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-9 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-10 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p40 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p70 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-13 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-15 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17A From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17F From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-18 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-21 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-23 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-31 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-27 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in LIF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in G-CSF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GM-CSF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SDF-1α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IP-10 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Eotaxin From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in RANTES From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-1 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-3 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIG From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TRAIL From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in CD40L From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-γ From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-α From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PIGF-1 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SCF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in HGF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF-D From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in NGF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in EGF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FGF-β From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in M-CSF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in BDNF From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ICAM-1 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VCAM-1 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ENA-78 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PDGF-BB From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PAI-1 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Leptin From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Resistin From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GROa From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FaSL From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-22 From Baseline.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Pain From Baseline.
Visual analog scale (0-100) anchored at "no pain" at 0 and "worst possible pain" at 100. Improvement in pain would be indicated by a decrease in the score.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Overall Fibromyalgia Symptoms From Baseline.
Visual analog scale (0-100) anchored at "no symptoms" at 0 and "worst possible symptoms" at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score.
Measured: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jul 2014

First posted8 Apr 2014 (estimated)
Study startMar 2014
Primary completionJul 2014
Study completionJul 2014

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 N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107014
Sponsor's protocol ID: 29911
Acronym: LDN-IM
Status last verified: Feb 2017
First submitted: 1 Apr 2014
Last updated: 11 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Dose Naltrexone (LDN) Immune Monitoring
ClinicalTrials.gov ID: NCT02107014
Acronym / sponsor ID: LDN-IM / 29911
Conditions: Fibromyalgia
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Stanford University
Study start: Mar 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
Low Dose Naltrexone (LDN)	Other	Drug: Low Dose NaltrexoneFollowing a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Females age 18-65
Meets criteria for 1990 ACR criteria for fibromyalgia
Able to receive venous blood draw twice a week for 16 weeks
Sufficient symptom variability during baseline report
Patient completes daily report during 2 week baseline period at least 80% completion rate.

Key exclusion criteria (13 listed)

Opioid use
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
Location prohibits travel to Stanford
Blood or clotting disorder
Rheumatologic or autoimmune disease

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: LDN, NaltrexoneNaltrexone 4.5 mg p.o. nocte	Drug	Low Dose Naltrexone (LDN)

Primary outcome

Change in IL-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-1Ra From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-2 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-4 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-5 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-6 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-7 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-8 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-9 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-10 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p40 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-12p70 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-13 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-15 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17A From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-17F From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-18 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-21 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-23 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-31 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-27 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in LIF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in G-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GM-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SDF-1α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IP-10 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Eotaxin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in RANTES From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIP-1β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MCP-3 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in MIG From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TRAIL From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in CD40L From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TGF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IFN-γ From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-α From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in TNF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PIGF-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in SCF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in HGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF-D From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VEGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in NGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in EGF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FGF-β From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in M-CSF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in BDNF From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ICAM-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in VCAM-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in ENA-78 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PDGF-BB From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in PAI-1 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Leptin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Resistin From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in GROa From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in FaSL From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in IL-22 From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Change in Pain From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Visual analog scale (0-100) anchored at "no pain" at 0 and "worst possible pain" at 100. Improvement in pain would be indicated by a decrease in the score.
Change in Overall Fibromyalgia Symptoms From Baseline.
Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Visual analog scale (0-100) anchored at "no symptoms" at 0 and "worst possible symptoms" at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score.

Results and safety

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Naltrexone (LDN)	9	8

Primary outcome: Change in IL-1α From Baseline.

Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].. Median (95% Confidence Interval). Unit: pg/mL

Measure	Low Dose Naltrexone (LDN) n = 8
IL-1α baseline 2-weeks	3.56 (3.52 to 4.43)
IL-1α last 2-weeks	3.88 (3.79 to 4.74)

Low Dose Naltrexone (LDN): p = .576, Mixed Models Analysis

Primary outcome: Change in IL-1β From Baseline.

Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].. Median (95% Confidence Interval). Unit: pg/mL

Measure	Low Dose Naltrexone (LDN) n = 8
IL-1β baseline 2-weeks	0.33 (0.16 to 14.98)
IL-1β last 2-weeks	0.26 (.04 to 10.88)

Low Dose Naltrexone (LDN): p = 0.010, Mixed Models Analysis

Primary outcome: Change in IL-1Ra From Baseline.

Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].. Median (95% Confidence Interval). Unit: pg/mL

Measure	Low Dose Naltrexone (LDN) n = 8
IL-1Ra baseline 2-weeks	2433.11 (2406.25 to 2500.26)
IL-1Ra last 2-weeks	2004.48 (1846.09 to 2164.39)

Low Dose Naltrexone (LDN): p = .008, Mixed Models Analysis

Primary outcome: Change in IL-2 From Baseline.

Time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].. Median (95% Confidence Interval). Unit: pg/mL

Measure	Low Dose Naltrexone (LDN) n = 8
IL-2 baseline 2-weeks	23.21 (4.98 to 105.98)
IL-2 last 2-weeks	21.32 (4.98 to 83.43)

Low Dose Naltrexone (LDN): p = .015, Mixed Models Analysis

Adverse events

Time frame: 8 week drug administration period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Naltrexone (LDN)	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): No placebo control drug used - participants were only advised that placebo may be used during the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 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 study testing Low Dose Naltrexone 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 13 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 11 Apr 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2017). 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?

Change in IL-1α From Baseline. (time frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].). The study lists 65 primary outcomes in all. 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 NCT02107014.

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 11 Apr 2017.