Effects of Low Dose Naltrexone in Fibromyalgia

This study has been completed.
American Fibromyalgia Syndrome Association
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
First received: December 4, 2007
Last updated: June 21, 2012
Last verified: June 2012

December 4, 2007
June 21, 2012
June 2007
January 2010   (final data collection date for primary outcome measure)
  • Pain [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
  • Pain
  • Fatigue
  • Sleep quality
Complete list of historical versions of study NCT00568555 on ClinicalTrials.gov Archive Site
  • Mechanical Pain [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
  • Thermal Pain Sensitivity [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
  • 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.

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
    Intervention: Drug: Low Dose Naltrexone
  • Placebo Comparator: Placebo - sugar pill
    Intervention: 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.
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.

18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
SU-10232007-756, 8948
Not Provided
Sean Mackey, Stanford University
Stanford University
American Fibromyalgia Syndrome Association
Sub-Investigator: Jarred Younger Stanford University
Stanford University
June 2012

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