Effects of Low Dose Naltrexone in Fibromyalgia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fibromyalgia Persian Gulf Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low Dose Naltrexone first

LDN first, then placebo.

Group Type EXPERIMENTAL

Low Dose Naltrexone

Intervention Type DRUG

3-4.5mg Naltrexone once daily

Placebo - sugar pill

Intervention Type DRUG

Placebo pill once daily

Placebo - sugar pill first

Placebo first, then LDN.

Group Type PLACEBO_COMPARATOR

Low Dose Naltrexone

Intervention Type DRUG

3-4.5mg Naltrexone once daily

Placebo - sugar pill

Intervention Type DRUG

Placebo pill once daily

Interventions

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Low Dose Naltrexone

3-4.5mg Naltrexone once daily

Intervention Type DRUG

Placebo - sugar pill

Placebo pill once daily

Intervention Type DRUG

Eligibility Criteria

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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.