NCT04450316

Low-dose Naltrexone for Bladder Pain Syndrome

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Naltrexone	4.5mg tab (low-dose) nightly
DRUG	Placebo	1 tab nightly

Timeline

• Start date: 2020-10-08
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2020-06-29
• Last updated: 2023-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study