Low-dose Naltrexone for Bladder Pain Syndrome

Overview

Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions.

The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.

Full Title of Study: “Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2021

Interventions

  • Drug: Naltrexone
    • 4.5mg tab (low-dose) nightly
  • Drug: Placebo
    • 1 tab nightly

Arms, Groups and Cohorts

  • Active Comparator: Low-dose naltrexone
    • 4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.
  • Placebo Comparator: Placebo
    • Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in 7-day average of worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment.
    • Time Frame: Will compare pre-intervention to week 8.

Secondary Measures

  • Change in Brief Pain Inventory Score
    • Time Frame: At pre-intervention to week 8.
  • Change in average frequency and nocturia during a 5-day voiding diary
    • Time Frame: At pre-intervention to week 8.
  • Change in Bladder Pain/Interstitial Cystitis Symptom Score
    • Time Frame: At pre-intervention to week 8
  • Change in O’Leary Sant symptom scores
    • Time Frame: At pre-intervention to week 8
  • Change in O’Leary Sant Problem Indices scores
    • Time Frame: At pre-intervention to week 8
  • Change in Global response assessment scale score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS pain behavior score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS physical function score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS sleep dysfunction score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS Sleep-Related Impairment
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS pain interference score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS fatigue score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS anxiety score
    • Time Frame: At pre-intervention to week 8
  • Change in PROMIS depression score
    • Time Frame: At pre-intervention to week 8

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women with non-Hunner and Hunner lesion disease
  • Meeting AUA definition of BPS: An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder associated with lower urinary tract symptoms of greater than 6 weeks duration in the absence of infection or other identifiable cause.
  • Stable treatment for 1 month
  • 7-day maximum of pain scores at least 4/10 on the numerical rating scale of pain in the bladder/pelvic area. Urinary frequency 8 or higher while awake. Nocturia 2 or higher. BPIC-SS 19.
  • Agreement to not take opioids through the duration of the trial

Exclusion Criteria

  • Substance Use Disorder Diagnosis including Opioid Use Disorder Diagnosis
  • Known allergy to naltrexone or naloxone
  • Participation in another clinical trial
  • Current or planned pregnancy, or breastfeeding
  • Chronic pain in another location of the body that is more severe than that related to BPS.
  • Any intravesical instillation in last 8 weeks
  • If on Elmiron, stable dose for last 3 months
  • If on amitriptyline, stable dose for last 3 months
  • Any botox within last 6 months
  • Treatment for Hunners in the last 6 months
  • Any new Interstim settings within last 3 months
  • Any new pelvic floor physical therapy in last 12 weeks
  • Any change in or new OTC meds over last 2 months.
  • Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks)
  • Opioids chronically for IC/BPS in the past unless have been off for 1 year
  • Recent short-term (within one week of enrollment) opioid use for flairs
  • No documented cystoscopy in the last 5 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Hah, Assistant Professor – Stanford University
  • Overall Official(s)
    • Jacqueline M Speed, MD, Study Director, Stanford University
    • Craig V Comiter, MD, Principal Investigator, Stanford University
    • Phil Hanno, MD, Principal Investigator, Stanford University
    • Jennifer M Hah, MD, MS, Principal Investigator, Stanford University
  • Overall Contact(s)
    • Gabrielle Hettie, 650-724-2091, bhettie@stanford.edu

References

Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15. Review.

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