Effects of Low Dose Naltrexone in Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
American Fibromyalgia Syndrome Association
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00568555
First received: December 4, 2007
Last updated: September 21, 2015
Last verified: September 2015

December 4, 2007
September 21, 2015
June 2007
January 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]

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.

  • Pain
  • Fatigue
  • Sleep quality
Complete list of historical versions of study NCT00568555 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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.

  • 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) ] [ Designated as safety issue: No ]

    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.

  • 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) ] [ Designated as safety issue: No ]
    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.
  • 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) ] [ Designated as safety issue: No ]
    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.
  • Mechanical Pain Sensitivity
  • Thermal pain sensitivity
Not Provided
Not Provided
 
Effects of Low Dose Naltrexone in Fibromyalgia
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fibromyalgia
  • Persian Gulf Syndrome
  • Drug: Low Dose Naltrexone
    3-4.5mg Naltrexone once daily
  • Drug: Placebo - sugar pill
    Placebo pill once daily
  • Experimental: Low Dose Naltrexone first
    LDN first, then placebo.
    Interventions:
    • Drug: Low Dose Naltrexone
    • Drug: Placebo - sugar pill
  • Placebo Comparator: Placebo - sugar pill first
    Placebo first, then LDN.
    Interventions:
    • Drug: Low Dose Naltrexone
    • Drug: Placebo - sugar pill
Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2010
January 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00568555
SU-10232007-756, 8948
Not Provided
Not Provided
Not Provided
Sean Mackey, Stanford University
Stanford University
American Fibromyalgia Syndrome Association
Sub-Investigator: Jarred Younger Stanford University
Stanford University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP