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Opioid Antagonist

Low-dose naltrexone for Interstitial Cystitis

Phase 2
Waitlist Available
Led By Phil Hanno, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-intervention to week 8
Awards & highlights

Study Summary

This trial will test if low-dose naltrexone improves pain and urinary symptoms in patients with interstitial cystitis/bladder pain syndrome.

Eligible Conditions
  • Interstitial Cystitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been experiencing pain, pressure, or discomfort in your bladder area for more than 6 weeks and no infection or other identifiable cause has been found.
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You have severe pain in your bladder or pelvic area, need to urinate frequently during the day, wake up to urinate at least twice a night, and your BPIC-SS score is 19 or higher.
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You cannot take opioids during the study.
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Both men and women with a certain type of bladder condition called non-Hunner and Hunner lesion disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-intervention to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-intervention to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 Bladder Pain/Interstitial Cystitis Symptom Score
Change in Brief Pain Inventory Score
Change in Global response assessment scale score
+11 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Low-dose naltrexoneActive Control1 Intervention
4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,319 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
12 Patients Enrolled for Interstitial Cystitis
Jacqueline M Speed, MDStudy DirectorStanford University
Phil Hanno, MDPrincipal InvestigatorStanford University

Media Library

Naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04450316 — Phase 2
Interstitial Cystitis Research Study Groups: Placebo, Low-dose naltrexone
Interstitial Cystitis Clinical Trial 2023: Naltrexone Highlights & Side Effects. Trial Name: NCT04450316 — Phase 2
Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04450316 — Phase 2
Interstitial Cystitis Patient Testimony for trial: Trial Name: NCT04450316 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients does this trial have space for?

"That is correct. The clinical trial was posted on October 8th, 2020 and is currently enrolling 40 patients at 1 location, according to the data available on clinicaltrials.gov"

Answered by AI

Are we currently looking for participants in this research?

"That is correct. The information available on clinicaltrials.gov verifies that this trial, which was originally advertised on October 8th 2020, currently has open enrolment slots. Up to 40 patients can be accepted from a single site."

Answered by AI

Can you explain the benefits of Low-dose naltrexone?

"Low-dose naltrexone has been successful in treating chronic weight management, increased physical activity, and pain."

Answered by AI

What are the risks associated with Low-dose naltrexone?

"Power team rates the safety of Low-dose naltrexone as being a 2. In clinical research, Phase 2 trials support the safety of a medication but not its efficacy."

Answered by AI

Could you please compare and contrast this clinical trial to others that have been completed with Low-dose naltrexone?

"Currently, there are 52 different ongoing clinical trials related to Low-dose naltrexone. Of these, 16 have reached Phase 3. Many of the trials for Low-dose naltrexone are based in New york; however, there are a total of 175 locations running similar studies."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have had IC since 2007. I believe this to be an embedded infection, but have had limited relired.
PatientReceived no prior treatments
~3 spots leftby Jul 2024