Low-dose Naltrexone for Bladder Pain Syndrome

Interstitial Cystitis Clinical Trial

Official title:

Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04450316
• Other study ID #: 57305
• Status: Suspended
• Phase: Phase 2
• Start date: October 8, 2020
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

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