Clinical trial NCT04450316: Low-dose Naltrexone for Bladder Pain Syndrome
Official title: Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Bladder Pain Syndrome
Interstitial Cystitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled pilot study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Will compare pre-intervention to week 8.
Secondary outcomes:
measure: Change in Brief Pain Inventory Score
timeFrame: At pre-intervention to week 8.
measure: Change in average frequency and nocturia during a 5-day voiding diary
timeFrame: At pre-intervention to week 8.
measure: Change in Bladder Pain/Interstitial Cystitis Symptom Score
timeFrame: At pre-intervention to week 8
measure: Change in O'Leary Sant symptom scores
timeFrame: At pre-intervention to week 8
measure: Change in O'Leary Sant Problem Indices scores
timeFrame: At pre-intervention to week 8
measure: Change in Global response assessment scale score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS pain behavior score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS physical function score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS sleep dysfunction score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS Sleep-Related Impairment
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS pain interference score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS fatigue score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS anxiety score
timeFrame: At pre-intervention to week 8
measure: Change in PROMIS depression score
timeFrame: At pre-intervention to week 8
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Craig V Comiter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Phil Hanno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jennifer M Hah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.