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Could a Low-Dose opioid blocker ease bladder pain?

NCT ID NCT04450316

Symptom relief Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This pilot trial investigates whether low-dose naltrexone (LDN) can reduce pain and urinary symptoms in people with bladder pain syndrome or interstitial cystitis. Participants receive either LDN or a placebo nightly for 8 weeks. The study measures pain scores, urinary frequency, and side effects to see if LDN offers a safe, effective treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone (low-dose)
What this could lead to
If it works, this could offer a new, low-side-effect option for managing chronic bladder pain and urinary symptoms.
What could go wrong
This is a small, early pilot trial with only 29 participants, so results may not apply broadly. The drug may not outperform placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Oct 2020

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

interstitial cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder pain syndrome Interstitial cystitis

Contacts and locations

Locations

  • Stanford Health Care

    Stanford, California, 94304, United States

More trials for these conditions

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