Effects of Low Dose Naltrexone in Fibromyalgia

Stanford University

Status: Completed

Conditions: Fibromyalgia; Persian Gulf Syndrome

Treatments: Drug: Low Dose Naltrexone; Drug: Placebo - sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT00568555

8948

SU-10232007-756

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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53 participants in 2 patient groups, including a placebo group

Low Dose Naltrexone first

Experimental group

Description:

LDN first, then placebo.

Treatment:

Drug: Low Dose Naltrexone

Drug: Placebo - sugar pill

Placebo - sugar pill first

Placebo Comparator group

Description:

Placebo first, then LDN.

Treatment:

Drug: Low Dose Naltrexone

Drug: Placebo - sugar pill