Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Intervention: Placebo; Sodium Oxybate
Intervention description: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.; Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic; fatigue; pain; sleep; xyrem; must have chronic fatigue syndrome; no hypertension; no sleep apnea

Summary:

      Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As
      a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having
      slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce
      the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to
      produce the rapid onset of deep sleep is a reason it became a street drug, but its
      availability is currently limited via distribution through a single centralized pharmacy.
      Xyrem has been successfully used based on results from a study on patients with fibromyalgia
      (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no
      information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from
      this study just which patient may be helped. I have prescribed Xyrem for patients who have
      both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I
      propose testing the drug's efficacy on patients with CFS alone - that is, they do not have
      fibromyalgia.

      Volunteers for this study will complete paper and pencil questionnaires about their symptoms
      as well as a computerized test to assess their degree of brain fog. They will then be
      randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group
      they are in until the end of the study. Only the drug group will receive the medication. The
      placebo group will receive a substance that looks identical to the real medicine but with no
      active ingredients. The medication comes as a liquid and patients will start taking an
      initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5
      hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told
      to skip taking the second dose. We will call patients weekly to see how they are doing on the
      "drug." If they have tolerable side effects or report significant improvement, we will
      maintain the dose. But if patients report no effect of treatment, the dosage will be
      incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is
      reached.
    

Eligibility criteria:

        Inclusion Criteria:

        • I have CFS

        Exclusion Criteria:

          -  I do not meet the above criteria

          -  I have a lifelong history of fatigue

          -  I have Fibromyalgia

          -  I have hypertension

          -  I am pregnant or breastfeeding