Skip to main content
OpenTrials
Completed

NCT Number: NCT00568555

Effects of Low Dose Naltrexone in Fibromyalgia

Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Occupational Diseases Persian Gulf Syndrome Rheumatic Diseases War-Related Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-65. Not taking any opioid analgesic Not pregnant or planning to become pregnant.

Exclusion criteria

Any known allergy to naltrexone or naloxone. Actual or planned pregnancy.

Treatment and study plan

Low Dose Naltrexone

Drug

3-4.5mg Naltrexone once daily

Placebo - sugar pill

Drug

Placebo pill once daily

Primary outcomes

  1. Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.

    Time frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

    Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.

    Baseline pain calculated averaging daily pain scores over the 2 week baseline period.

    Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.

    Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100.

Secondary outcomes

  1. Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.

    Time frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

    Visual Analogue Scale for sleep quality, 0 to 100, where 0 = "did not sleep well at all" and 100 = "slept extremely well".

    Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.

    Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.

    Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100.

  2. Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.

    Time frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

    Visual Analogue Scale for fatigue, 0 to 100, where 0 = "no fatigue at all" and 100 = "severe fatigue".

    Baseline fatigue calculated averaging daily scores over the 2 week baseline period.

    Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.

    Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100.

  3. Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.

    Time frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

    An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.

  4. Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.

    Time frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

    A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Fibromyalgia Syndrome Association

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 6, 2007
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.