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Low-dose Naltrexone for Bladder Pain Syndrome

NCT ID: NCT04450316

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Pain Syndrome Interstitial Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Low-dose naltrexone

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

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

4.5mg tab (low-dose) nightly

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tab nightly

Interventions

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Naltrexone

4.5mg tab (low-dose) nightly

Intervention Type DRUG

Placebo

1 tab nightly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig V Comiter, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Phil Hanno, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jennifer M Hah, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24526250 (View on PubMed)

Other Identifiers

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57305

Identifier Type: -

Identifier Source: org_study_id