IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
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|ClinicalTrials.gov Identifier: NCT04313972|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : September 20, 2021
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia.
Several treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia.
The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes.
This will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary.
Participants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study participants will also receive first-line behavioral therapy for IC/PBS of a bladder diet and bladder drills.
After six weeks, participants will complete a second bladder diary. They will then complete the exit study questionnaires, have a second liver function test, return any unused medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Painful Bladder Syndrome Bladder Pain Syndrome Low Dose Naltrexone Low-dose Naltrexone Naltrexone||Drug: low-dose naltrexone Drug: Placebo oral tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, the Effect of Low Dose Naltrexone on Symptoms and Pain of Patients With Interstitial Cystitis/Painful Bladder Syndrome a Randomized Placebo-controlled Prospective Trial|
|Actual Study Start Date :||September 7, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Low-dose naltrexone
2mg low-dose naltrexone capsules
Drug: low-dose naltrexone
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
Placebo Comparator: Placebo
Drug: Placebo oral tablet
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
- Interstitial Cystitis Symptom Index [ Time Frame: six weeks ]The effect of LDN in decreasing symptoms associated with IC/PBS when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.
- Visual analog scale [ Time Frame: six weeks ]The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 100, with lower scores indicating less pain.
- Interstitial Cystitis Problem Index [ Time Frame: six weeks ]The decrease in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS.
- Urinary frequency [ Time Frame: six weeks ]The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
- Nocturia [ Time Frame: six weeks ]The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
- pelvic pain and urgency/frequency symptoms [ Time Frame: six weeks ]The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS.
- pelvic pain and urgency/frequency bother [ Time Frame: six weeks ]The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms.
- Patient perceived changes in quality of life: SF-36 [ Time Frame: six weeks ]Patient perceived changes in quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.
- Adverse effects [ Time Frame: 6 weeks ]The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.
- Medication tolerability [ Time Frame: 6 weeks ]Patient tolerability of low-dose naltrexone using a tolerability survey, as well as instructing the patient to return any remaining medication at the end of the 6 week study period
- Change in pain medications [ Time Frame: 6 weeks ]The decrease in use of pain medications while using LDN as determined by a pain medication diary
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 ClinicalTrials.gov identifier (NCT number): NCT04313972
|Contact: Nani P Moss, MD, MPHemail@example.com|
|Contact: Roger P Goldberg, MD, MPHfirstname.lastname@example.org|
|United States, Illinois|
|Center for Pelvic Health at the NorthShore University HealthSystem||Recruiting|
|Skokie, Illinois, United States, 60076|
|Contact: Nani Moss, MD MPH 224-251-2374|