Low Dose Naltrexone (LDN) Immune Monitoring

NCT ID: NCT02107014

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Low Dose Naltrexone (LDN)

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.

Group Type: OTHER

Low Dose Naltrexone

Intervention Type: DRUG

Naltrexone 4.5 mg p.o. nocte

Interventions

Low Dose Naltrexone

Naltrexone 4.5 mg p.o. nocte

Intervention Type: DRUG

Other Intervention Names

LDN; Naltrexone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jarred W. Younger

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jarred Younger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

29911

Identifier Type: -

Identifier Source: org_study_id