Trial of Naltrexone and Dextromethorphan for Gulf War Illness
Condition: Gulf War Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments
      with FDA approved generic drugs are being administered to see if they help with the symptoms
      of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and
      thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are
      dextromethorphan and naltrexone.
    

Detailed description: 
      Gulf war veterans' illnesses comprise distinct clusters of symptom-defined illnesses for
      which there are neither diagnostic tests nor effective treatments. Gulf war veterans had
      variable exposures to a number of chemicals, including organophosphate insecticides,
      pyrethrum-related insecticides, DEET, Pyridostigmine bromide, smoke from oil well fires, and
      Sarin gas. Gulf war veterans' illnesses may reflect an inflammatory cycle involving the brain
      which may be a common mechanism of many neurological conditions, whether initiated by toxic
      exposures, infection, or trauma. In this theory, central nervous system inflammation
      initiated by toxic exposures and sometimes exacerbated by subsequent exposures is a component
      of illness hypothesized to explain the neurological manifestations. Substance P release at
      sensory nerve endings is an explanation for the peripheral pain manifestations of illness.

      This theory suggests that novel anti-inflammatory drugs may be of benefit in symptom-defined
      illnesses related to a cycle of inflammation. Dr. J. S. Hong's laboratory at the National
      Institute of Environmental Health Sciences has demonstrated that Morphine-related analogs,
      including Naltrexone and Dextromethorphan, have great potency in anti-inflammation and
      neuroprotective effects. Naltrexone is a safe and readily available generic medication.
      Dextromethorphan is also a safe and readily available generic medication that is available
      without a prescription as a cough medication. Results from several clinical trials showed
      that Naltrexone is effective in several inflammation-related diseases, such as neurogenic
      pain, movement disorders, etc. In addition, there were no obvious side effects in patients
      taking this drug for six months. This project will conduct randomized double-blinded studies
      for treating ill Gulf war veterans with Naltrexone and Dextromethorphan. Laboratory tests for
      markers of inflammation including neurogenic inflammation will be performed pre- and
      post-treatment, to see if these markers are elevated and if so, to see if treatment modulates
      these markers.

      Ill Gulf veterans will be recruited through the media, veterans groups, and individual
      veteran activists. A screening telephone interview will be performed to determine if the
      veterans meet a modified Kansas case definition for inclusion. Those veterans who meet study
      criteria will be invited to participate. Eligible veterans will be invited for an initial
      visit that will consist of obtaining written informed consent, a medical history, physical
      examination, and laboratory testing. Institutional review board approval of the study will be
      in place. The pharmacy staff at the institution will prepare the medications and placebo in
      identical capsules.
    

Intervention name(s): naltrexone; Dextromethorphan
Intervention type(s): Drug; Drug
Intervention description(s): Randomized controlled trial of naltrexone for Gulf War Illness.; Randomized controlled trial of dextromethorphan for Gulf War Illness
Intervention MeSH terms: Naltrexone; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gulf War Illness; treatment; dextromethorphan; naltrexone