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Low-dose Naltrexone for Bladder Pain Syndrome

Primary Purpose

Bladder Pain Syndrome, Interstitial Cystitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low-dose naltrexone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Brief Pain Inventory Score
Change in average frequency and nocturia during a 5-day voiding diary
Change in Bladder Pain/Interstitial Cystitis Symptom Score
Change in O'Leary Sant symptom scores
Change in O'Leary Sant Problem Indices scores
Change in Global response assessment scale score
Change in PROMIS pain behavior score
Change in PROMIS physical function score
Change in PROMIS sleep dysfunction score
Change in PROMIS Sleep-Related Impairment
Change in PROMIS pain interference score
Change in PROMIS fatigue score
Change in PROMIS anxiety score
Change in PROMIS depression score

Full Information

First Posted
June 24, 2020
Last Updated
July 7, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04450316
Brief Title
Low-dose Naltrexone for Bladder Pain Syndrome
Official Title
Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Pain Syndrome, Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled pilot study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-dose naltrexone
Arm Type
Active Comparator
Arm Description
4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
4.5mg tab (low-dose) nightly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tab nightly
Primary Outcome Measure Information:
Title
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.
Time Frame
Will compare pre-intervention to week 8.
Secondary Outcome Measure Information:
Title
Change in Brief Pain Inventory Score
Time Frame
At pre-intervention to week 8.
Title
Change in average frequency and nocturia during a 5-day voiding diary
Time Frame
At pre-intervention to week 8.
Title
Change in Bladder Pain/Interstitial Cystitis Symptom Score
Time Frame
At pre-intervention to week 8
Title
Change in O'Leary Sant symptom scores
Time Frame
At pre-intervention to week 8
Title
Change in O'Leary Sant Problem Indices scores
Time Frame
At pre-intervention to week 8
Title
Change in Global response assessment scale score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS pain behavior score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS physical function score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS sleep dysfunction score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS Sleep-Related Impairment
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS pain interference score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS fatigue score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS anxiety score
Time Frame
At pre-intervention to week 8
Title
Change in PROMIS depression score
Time Frame
At pre-intervention to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabrielle Hettie
Phone
650-724-2091
Email
bhettie@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig V Comiter, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phil Hanno, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer M Hah, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Hettie
Phone
650-724-2091
Email
bhettie@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Should the study result be positive or promising, we would undertake a larger trial at which point we can reassess the sharing of IPD.
Citations:
PubMed Identifier
24526250
Citation
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.
Results Reference
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Low-dose Naltrexone for Bladder Pain Syndrome

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