Low-dose Naltrexone for Bladder Pain Syndrome

NCT04450316 | Suspended Phase 2 FDA Drug

• 1 other identifier: 57305
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Pain Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Will compare pre-intervention to week 8.

Secondary Outcomes (14)

• Change in Brief Pain Inventory Score

  At pre-intervention to week 8.

• Change in average frequency and nocturia during a 5-day voiding diary

  At pre-intervention to week 8.

• Change in Bladder Pain/Interstitial Cystitis Symptom Score

  At pre-intervention to week 8

• Change in O'Leary Sant symptom scores

  At pre-intervention to week 8

• Change in O'Leary Sant Problem Indices scores

  At pre-intervention to week 8

Study Arms (2)

Low-dose naltrexone

ACTIVE COMPARATOR

4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.

Drug: Placebo

Interventions

Naltrexone DRUG

4.5mg tab (low-dose) nightly

Low-dose naltrexone

Placebo DRUG

1 tab nightly

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 24526250 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Craig V Comiter, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Phil Hanno, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jennifer M Hah, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized on a 1:1 ratio to either LDN or placebo. The randomization sequence will be logged by the study coordinator in a REDCap randomization log blinded to other research staff and clinical team and outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized placebo-controlled pilot study

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: October 8, 2020
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)