Effects of Low Dose Naltrexone in Fibromyalgia - Full Text View

Purpose

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
Fibromyalgia Persian Gulf Syndrome	Drug: Naltrexone

MedlinePlus related topics:

Fibromyalgia

ChemIDplus related topics:

Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Effects of Low Dose Naltrexone in Fibromyalgia

Further study details as provided by Stanford University:

Primary Outcome Measures:

Pain
Fatigue
Sleep quality

Secondary Outcome Measures:

Mechanical Pain Sensitivity
Thermal Pain Sensitivity

Estimated Enrollment:	60
Study Start Date:	June 2007

Detailed Description:

This study will be a placebo-controlled, single-blind, pre-post drug trial. 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.

Eligibility

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

Criteria

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

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

Locations


United States, California
	Stanford University School of Medicine	Recruiting
	Stanford, California, United States, 94305
	Contact: Jarred Younger LDN_Younger@stanford.edu
	Principal Investigator: Sean Mackey
	Sub-Investigator: Jarred Younger

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Sean Mackey	Stanford University

More Information

Study ID Numbers:	SU-10232007-756, 8948
First Received:	December 4, 2007
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00568555
Health Authority:	USA:Office of Human Research Protection

Study placed in the following topic categories:

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Naltrexone

Disorders of Environmental Origin

Occupational Diseases

Pain

Rheumatic Diseases

Persian Gulf Syndrome

Additional relevant MeSH terms:

Pathologic Processes

Disease

Sensory System Agents

Therapeutic Uses

Syndrome

Physiological Effects of Drugs

Narcotic Antagonists

Nervous System Diseases

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00568555