Low Dose Naltrexone (LDN) Immune Monitoring (LDN-IM)

The University of Alabama at Birmingham

Status: Completed

Conditions: Fibromyalgia

Treatments: Drug: Low Dose Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT02107014

29911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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 design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 1 patient group

Low Dose Naltrexone (LDN)

Other group

Description:

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.

Treatment:

Drug: Low Dose Naltrexone