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Hormone Therapy

Oxytocin Nasal Spray for Chronic Pain

Phase 2 & 3
Recruiting
Led By Joshua Rash, PhD
Research Sponsored by Memorial University of Newfoundland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On stable medication for pain management for 3 months or more with no anticipated changes during the 10-weeks of this trial
Surrey, BC: Men and women with primary neuropathic pain - pain arising as a direct consequence of a lesion or disease affecting the central or peripheral nervous system - will be eligible. Neuropathic pain will be screened for using a score of 3+ on the Douleur Neuropathique 4 Interview, and confirmed through investigation (e.g., electromyography)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 1 to day 14 of nasal spray administration.
Awards & highlights

Study Summary

This trial is testing whether a nasal spray containing oxytocin can help improve pain management for people with chronic pain.

Who is the study for?
Adult men and premenopausal women with chronic pain in muscles, nerves, or the pelvic region can join this trial. They must have moderate pain levels and be on stable pain medication for at least 3 months. Participants should not be pregnant, planning pregnancy, or have significant depression or certain medical conditions like heart issues or nasal pathology.Check my eligibility
What is being tested?
The study tests if a nasal spray containing oxytocin can improve chronic pain management compared to a placebo. Participants will use two different doses of oxytocin sprays and one placebo spray across three sessions without knowing which they're receiving. Their daily pain and function ratings will help determine the effectiveness of oxytocin.See study design
What are the potential side effects?
Oxytocin may cause side effects such as possible allergic reactions for those sensitive to its components. Since it's administered nasally, some participants might experience local irritation or discomfort in their nose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable pain medication plan for 3+ months with no changes expected.
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I have nerve pain due to damage in my nervous system, confirmed by tests.
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I can commit to using two forms of contraception or one highly effective method.
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I am an adult over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 1 to day 14 of nasal spray administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 1 to day 14 of nasal spray administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain intensity
Pain-related interference
Secondary outcome measures
Emotional function
Global Impression of Change
Sleep Disturbance

Trial Design

2Treatment groups
Experimental Treatment
Group I: Crossover sequence 2: placebo firstExperimental Treatment3 Interventions
Patients receive 2-weeks courses of placebo, 24-IU oxytocin, 48-IU oxytocin.
Group II: Crossover sequence 1: Oxytocin firstExperimental Treatment3 Interventions
Patients receive 2-weeks courses of 24-IU oxytocin, placebo, 48-IU oxytocin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER
1,418 Previous Clinical Trials
2,466,782 Total Patients Enrolled
8 Trials studying Chronic Pain
336 Patients Enrolled for Chronic Pain
Memorial University of NewfoundlandLead Sponsor
68 Previous Clinical Trials
1,831,686 Total Patients Enrolled
2 Trials studying Chronic Pain
105 Patients Enrolled for Chronic Pain
University of CalgaryOTHER
792 Previous Clinical Trials
868,818 Total Patients Enrolled
6 Trials studying Chronic Pain
300 Patients Enrolled for Chronic Pain

Media Library

24-IU oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04903002 — Phase 2 & 3
Chronic Pain Research Study Groups: Crossover sequence 1: Oxytocin first, Crossover sequence 2: placebo first
Chronic Pain Clinical Trial 2023: 24-IU oxytocin Highlights & Side Effects. Trial Name: NCT04903002 — Phase 2 & 3
24-IU oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903002 — Phase 2 & 3
Chronic Pain Patient Testimony for trial: Trial Name: NCT04903002 — Phase 2 & 3

Frequently Asked Questions

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

What are the other common maladies that this line of medicine is used to target?

"This intervention can be used to stop or prevent hemorrhage, aid in childbirth, and help with uterine contractions."

Answered by AI

Are people with the necessary qualifications currently able to participate in this research project?

"That is correct. The information available on clinicaltrials.gov states that the trial is still looking for participants. The study was first advertised on April 1st, 2022 and the most recent update was on September 7th, 2022. There are plans to enroll 336 patients from 3 different locations."

Answered by AI

Are there any other examples in which this therapy has been tested in a clinical setting?

"This treatment was first researched in 2011 at the Hadassah University Medical Organization. As of now, there have been 18,476 completed clinical trials. 57 studies are still ongoing, with a large presence in Carbonear, Newfoundland and Labrador."

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
What site did they apply to?
Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

I currently take duluxotene, fosomax, Ritalin and kadian. If chosen do I have to stop my meds?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have had chronic pain 35+ years. I don’t sleep well any relief would be great.
PatientReceived no prior treatments
I have had chronic pain with chronic depression 30+ years I am willing to try anything new that would make my life a bit better.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC): < 24 hours
Typically responds via
Email
Recent research and studies
BMJ OpenJournal
Evaluating the Efficacy of Intranasal Oxytocin on Pain and Function Among Individuals Who Experience Chronic Pain: A Protocol for a Multisite, Placebo-controlled, Blinded, Sequential, Within-subjects Crossover Trial
Rash, Joshua A., Tavis S. Campbell, Lynn Cooper, David Flusk, Aaron MacInnes, Maryam Nasr-Esfahani, Anastasia A. Mekhael, Patricia A. Poulin, Magali Robert, and Yanqing Yi. 2021. “Evaluating the Efficacy of Intranasal Oxytocin on Pain and Function Among Individuals Who Experience Chronic Pain: A Protocol for a Multisite, Placebo-controlled, Blinded, Sequential, Within-subjects Crossover Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-055039.
clinicaltrials.govStudy
Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain
2022. "Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903002.
All > American Chronic Pain > Oxytocin
~13 spots leftby Jun 2024
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