Conditions: Fibromyalgia Persian Gulf Syndrome
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 53
Healthy volunteers: no

Brief summary:
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.

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.

Arms:
arm 1: LDN first, then placebo. arm 2: Placebo first, then LDN.

Interventions: intervention 1: Low Dose Naltrexone intervention 2: Placebo - sugar pill
Intervention descriptions: intervention 1: 3-4.5mg Naltrexone once daily intervention 2: Placebo pill once daily

Protocol document: