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Low-dose Naltrexone for Bladder Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04450316
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : July 11, 2022
Information provided by (Responsible Party):
Jennifer Hah, Stanford University

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.

Condition or disease Intervention/treatment Phase
Bladder Pain Syndrome Interstitial Cystitis Drug: Naltrexone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo-controlled pilot study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low-dose naltrexone
4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.
Drug: Naltrexone
4.5mg tab (low-dose) nightly

Placebo Comparator: Placebo
Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.
Drug: Placebo
1 tab nightly

Primary Outcome Measures :
  1. 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 Measures :
  1. Change in Brief Pain Inventory Score [ Time Frame: At pre-intervention to week 8. ]
  2. Change in average frequency and nocturia during a 5-day voiding diary [ Time Frame: At pre-intervention to week 8. ]
  3. Change in Bladder Pain/Interstitial Cystitis Symptom Score [ Time Frame: At pre-intervention to week 8 ]
  4. Change in O'Leary Sant symptom scores [ Time Frame: At pre-intervention to week 8 ]
  5. Change in O'Leary Sant Problem Indices scores [ Time Frame: At pre-intervention to week 8 ]
  6. Change in Global response assessment scale score [ Time Frame: At pre-intervention to week 8 ]
  7. Change in PROMIS pain behavior score [ Time Frame: At pre-intervention to week 8 ]
  8. Change in PROMIS physical function score [ Time Frame: At pre-intervention to week 8 ]
  9. Change in PROMIS sleep dysfunction score [ Time Frame: At pre-intervention to week 8 ]
  10. Change in PROMIS Sleep-Related Impairment [ Time Frame: At pre-intervention to week 8 ]
  11. Change in PROMIS pain interference score [ Time Frame: At pre-intervention to week 8 ]
  12. Change in PROMIS fatigue score [ Time Frame: At pre-intervention to week 8 ]
  13. Change in PROMIS anxiety score [ Time Frame: At pre-intervention to week 8 ]
  14. Change in PROMIS depression score [ Time Frame: At pre-intervention to week 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04450316

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Contact: Gabrielle Hettie 650-724-2091

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United States, California
Stanford Health Care Recruiting
Stanford, California, United States, 94304
Contact: Gabrielle Hettie    650-724-2091   
Sponsors and Collaborators
Stanford University
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Principal Investigator: Craig V Comiter, MD Stanford University
Principal Investigator: Phil Hanno, MD Stanford University
Principal Investigator: Jennifer M Hah, MD, MS Stanford University
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Responsible Party: Jennifer Hah, Assistant Professor, Stanford University Identifier: NCT04450316    
Other Study ID Numbers: 57305
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Additional relevant MeSH terms:
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Cystitis, Interstitial
Somatoform Disorders
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents