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

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.

Condition Intervention
Persian Gulf Syndrome
Drug: Low Dose Naltrexone
Drug: Placebo - sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Low Dose Naltrexone in Fibromyalgia

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Naltrexone Drug: Low Dose Naltrexone
3-4.5mg Naltrexone once daily
Placebo Comparator: Placebo - sugar pill Drug: Placebo - sugar pill
Placebo pill once daily

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00568555

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
American Fibromyalgia Syndrome Association
Sub-Investigator: Jarred Younger Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sean Mackey, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00568555     History of Changes
Other Study ID Numbers: SU-10232007-756, 8948
Study First Received: December 4, 2007
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Persian Gulf Syndrome
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Occupational Diseases
Rheumatic Diseases
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 08, 2015