Completed

LDN-IMLow Dose Naltrexone (LDN) Immune Monitoring

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Low Dose Naltrexone

Drug
Who is being recruted

Fibromyalgia+3

+ Muscular Diseases

+ Musculoskeletal Diseases

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: March 2014
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleLow Dose Naltrexone (LDN) Immune Monitoring
NCT02107014
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesRheumatic Diseases

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
13 exclusion criteria prevent from participating
Opioid use
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
Location prohibits travel to Stanford
Blood or clotting disorder
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford University School of Medicine

Palo Alto, United StatesOpen Stanford University School of Medicine in Google Maps
CompletedOne Study Center