Status:
RECRUITING
Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain
Lead Sponsor:
Memorial University of Newfoundland
Collaborating Sponsors:
University of Calgary
University of British Columbia
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 li...
Detailed Description
Background and Importance: Chronic pain affects 1 in 5 Canadians and is associated with considerable burden, both individual (disability, reduced physical and emotional function) and economic ($43 bil...
Eligibility Criteria
Inclusion
- Inter-Site
- Adult (\> 18 years) men and premenopausal women;
- On stable medication for pain management for 3 months or more with no anticipated changes during the 10-weeks of this trial;
- Moderate pain at baseline (i.e., a score of 4-8 on a 10-point numeric rating scale) to prevent floor and ceiling effects.
- Can commit the use of two forms of effective contraception (e.g., barrier methods), or one highly effective method, including abstinence, intrauterine device, intrauterine system (IUS), vasectomy, tubal ligation, or hormonal contraceptive (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants)
- Intra-Site
- 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).
- Calgary, AB: Women with chronic (intermittent or constant) pelvic musculoskeletal pain (i.e., located primarily in the pelvic region and reproducible on palpation of the pelvic floor) who have not received a hysterectomy will be eligible. Women with a primary diagnosis of endometriosis, dysmenorrhea, functional bowel disorder, interstitial cystitis, fibromyalgia or sacroiliac instability as defined by European Guidelines, will be excluded.
- Carbonear NL: Men and women with primary musculoskeletal pain of back, neck, or shoulder origin will be eligible. Pain will be assessed using the BPI-SF and confirmed through physical examination.
Exclusion
- Positive urine pregnancy test or contemplating pregnancy;
- Concurrent use of another nasal spray;
- Nasal pathology (e.g., ears, nose, and throat diagnosis);
- Diabetes insipidus;
- Current diagnosis or history of cancer
- Significant unmanaged psychopathology (e.g., severe depression as indicated by a score ≥ 15 on the Patient Health Questionnaire -9) due to its inverse association with patient adherence to procedures; and
- Receiving hormone treatment for gender-related motivations.
- documented cardiovascular event (e.g., myocardial infarction)
- known prolongation of the QTc interval; 10) known hypersensitivity to oxytocin
- known latex allergy
- known or suspected renal impairment.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT04903002
Start Date
April 1 2022
End Date
March 31 2026
Last Update
November 20 2024
Active Locations (3)
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1
Calgary Chronic Pain Centre
Calgary, Alberta, Canada, T2T 5C7
2
Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC)
Surrey, British Columbia, Canada, V3T0G9
3
Carbonear General Hospital
Carbonear, Newfoundland and Labrador, Canada, A1Y 1A4