Low-dose Naltrexone for Bladder Pain Syndrome

Stanford University

Status and phase: Suspended; Phase 2

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Drug: Placebo; Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT04450316

57305

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Low-dose naltrexone

Active Comparator group

Description:

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

Treatment:

Drug: Naltrexone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo