IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
Condition: Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome; Low Dose Naltrexone; Low-dose Naltrexone; Naltrexone
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with
      symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain,
      without evidence of urinary tract infection or other identifiable causes. IC/PBS often
      coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue
      syndrome, and fibromyalgia.

      Several treatments exist for IC/PBS; some are not effective, others are time consuming for
      patients to receive, some can take weeks to months before they become effective, and many
      have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of
      symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone.
      Some adverse effects have been reported with LDN, the most common are vivid dreams,
      nightmares, and insomnia.

      The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined
      by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline
      when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain
      literature. This improvement has been seen in prior studies where LDN was used to treat pain
      syndromes.

      This will be a randomized double-blinded placebo-controlled prospective trial. Patients
      meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will
      be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study
      participants will sign a consent, complete several questionnaires, give a blood sample to
      measure liver function tests, and once at home, complete a 24-hour bladder diary.

      Participants will be randomized to receive either placebo or study medication. Participants
      will be instructed to take one capsule nightly for two weeks, then increase to two capsules
      nightly for four weeks. They will be given a log to record the date and time they take the
      medication. All study participants will also receive first-line behavioral therapy for IC/PBS
      of a bladder diet and bladder drills.

      After six weeks, participants will complete a second bladder diary. They will then complete
      the exit study questionnaires, have a second liver function test, return any unused
      medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.
    


Intervention name(s): low-dose naltrexone; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks; 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment