Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain

NCT04903002 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-02-18

No results posted yet for this study

Summary

One in five Canadians live with chronic pain, defined as pain that lasts longer than 3-months. Living with chronic pain has a detrimental impact on physical health, emotional health, and quality of life. Current treatments rarely result in pain relief and often do not meaningfully improve physical or emotional function. Further, medication used to treat pain often causes unwanted symptoms. There is a need to develop new treatments to help manage chronic pain. The use of a nasal spray containing manufactured oxytocin may improve pain management. Oxytocin is produced in the human body and has been shown to impact the pain pathway in animals. Our project tests whether the use of a nasal spray containing oxytocin will improve pain and function in men and women who live with chronic pain. Men and women with chronic nerve, muscle, or pelvic pain will be recruited in Vancouver, Calgary, and St. John's. Each person will be assigned to complete three interventions in a random order. Each intervention involves using a nasal spray twice per day over a 2-week period. The nasal spray will contain a small dose of oxytocin during one intervention and a medium dose during the second intervention. The nasal spray during the final intervention will have no oxytocin. This final intervention is a control intervention that will allow us to measure the effect of simply taking a nasal spray (i.e., the impact of expectation). Participants and researchers will not know which interventions involve the use of oxytocin. Participants will rate their pain and function each day throughout each task. The investigators will calculate each person's score on pain and function. The investigators will test whether participants report less pain and better function when they use oxytocin compared to the control. The results of this project may improve pain, function, and quality of life among those who live with chronic pain.

Conditions

Interventions

DRUG

24-IU oxytocin

Patients will self-administer a 2-week course of 24-IU intranasal oxytocin \[4-IU per puff (12-IU delivered to each nostril); Syntocinon, Novartis, Switzerland\], twice per day (once in the morning and once in the evening).

DRUG

48-IU oxytocin

Patients will self-administer a 2-week course of 48-IU intranasal oxytocin \[4-IU per puff (24-IU delivered to each nostril); Syntocinon, Novartis, Switzerland\], twice per day (once in the morning and once in the evening).

DRUG

Placebo

Patients will receive an intranasal placebo containing the same ingredients as the oxytocin nasal spray with the exception of active oxytocin. Administration schedule and procedure will be identical to that described in 24-IU oxytocin.

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • Memorial University of Newfoundland

    lead OTHER

Principal Investigators

  • Joshua Rash, PhD · Memorial University of Newfoundland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04903002 on ClinicalTrials.gov