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Opioid Antagonist

low-dose naltrexone for Interstitial Cystitis

Phase 4
Waitlist Available
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights

Study Summary

This trial is testing whether low-dose naltrexone improves symptoms in people with interstitial cystitis/painful bladder syndrome.

Eligible Conditions
  • Interstitial Cystitis
  • Low Dose Naltrexone
  • Naltrexone

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interstitial Cystitis Symptom Index
Visual analog scale
Secondary outcome measures
Adverse effects
Change in pain medications
Interstitial Cystitis Problem Index
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-dose naltrexoneExperimental Treatment1 Intervention
2mg low-dose naltrexone capsules
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
low-dose naltrexone
2021
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,858 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
83 Patients Enrolled for Interstitial Cystitis

Frequently Asked Questions

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

What indications does low-dose naltrexone commonly address?

"Low-dose naltrexone is usually used to manage chronic weight, but it can also be applied therapeutically to increase physical activity, reduce pain and support a reduced calorie diet."

Answered by AI

What potential adverse effects might patients encounter when taking low-dose naltrexone?

"There is ample evidence that low-dose naltrexone has been approved for use, thus receiving a score of 3 on the safety scale."

Answered by AI

How many participants is the study recruiting?

"Indeed, the clinicaltrials.gov portal indicates that this research trial is actively collecting patients for their study. It was published on September 7th 2021 and last reviewed on April 4th 2022. In total, 44 subjects are needed from one site."

Answered by AI

What is the primary goal of this research endeavor?

"The primary metric of this six-week clinical trial is the Visual Analogue Scale. Secondary outcomes encompass the Pelvic Pain and Urgency/Frequency Patient Symptom Scale (ranging from 0 to 23, with higher scores indicating more severe IC/PBS symptoms), a survey of patient Quality of Life via SF-36 (from 0 to 100, where better health status is indicated by greater values) as well as urinary frequency observed through 24 hour bladder diaries."

Answered by AI

Am I eligible to join this clinical experiment?

"This clinical trial seeks 44 participants aged 18 to 110 who suffer from bladder-related discomfort. In addition, candidates must have not been treated for the condition in the last four weeks, be able to communicate fluently in English and provide a blood sample for liver enzyme evaluation. Furthermore, they should have had cystoscopy within 6 months prior to study commencement and possess a functioning telephone number."

Answered by AI

Are there any other research endeavors that have examined the effects of minimal dosages of naltrexone?

"Currently, there are 46 clinical trials centred around low-dose naltrexone. Of those studies, 12 have advanced to Phase 3. Despite the majority of these investigations being based in New york City, there are 161 different sites running related research globally."

Answered by AI

Are geriatric individuals being accepted in this experiment?

"The boundaries for this trial are set at 18 to 110 years of age. For those outside the range, 454 studies are available for participants under 18 and 1284 clinical trials exist that cater to individuals aged 65 or older."

Answered by AI

Are there still opportunities to become involved in this clinical investigation?

"Affirmative. Clinicaltrials.gov exhibits that this clinical trial is still enrolling participants, with the first post on September 7th 2021 and a recent update on April 4th 2022. The research team need to recruit 44 individuals from 1 medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Wisconsin
Tennessee
How old are they?
18 - 65
What site did they apply to?
Center for Pelvic Health at the NorthShore University HealthSystem
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~1 spots leftby Apr 2025