Using a nasal spray of oxytocin to help manage chronic pain

Evaluating the Efficacy of Intranasal Oxytocin on Pain and Function Among Individuals Who Experience Chronic Pain: a Multisite, Placebo-controlled, Blinded, Sequential, Within-subjects Crossover Trial

This study tests if a nasal spray of oxytocin can help people with chronic pain feel better and improve their daily activities.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial University of Newfoundland (Academic / other)
• Locations: 3 sites (Calgary, Alberta and 2 other locations)
• Trial ID: NCT04903002 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of intranasal oxytocin as a treatment for chronic pain, which affects a significant portion of the population. The study involves a multi-site, placebo-controlled design where participants will receive different doses of oxytocin or a placebo in a randomized order. The aim is to determine if oxytocin can improve pain relief and overall function in individuals suffering from chronic nerve, muscle, or pelvic pain. Participants will be closely monitored over a 10-week period while maintaining their current pain management medications.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with moderate chronic pain who have been on stable pain management medication for at least three months.

Not a fit: Patients who are not experiencing moderate pain or those who are not on stable pain management medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-addictive option for managing chronic pain, improving patients' quality of life.

How similar studies have performed: While there is limited rigorous research on oxytocin's effects on human pain management, animal studies have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

Inter-Site Inclusion Criteria:

1. Adult (\> 18 years) men and premenopausal women;
2. On stable medication for pain management for 3 months or more with no anticipated changes during the 10-weeks of this trial;
3. Moderate pain at baseline (i.e., a score of 4-8 on a 10-point numeric rating scale) to prevent floor and ceiling effects.
4. 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 Inclusion Criteria:

1. 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).
2. 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.
3. 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 Criteria:

1. Positive urine pregnancy test or contemplating pregnancy;
2. Concurrent use of another nasal spray;
3. Nasal pathology (e.g., ears, nose, and throat diagnosis);
4. Diabetes insipidus;
5. Current diagnosis or history of cancer
6. 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
7. Receiving hormone treatment for gender-related motivations.
8. documented cardiovascular event (e.g., myocardial infarction)
9. known prolongation of the QTc interval; 10) known hypersensitivity to oxytocin
10. known latex allergy
11. known or suspected renal impairment.

Where this trial is running

Calgary, Alberta and 2 other locations

• Calgary Chronic Pain Centre — Calgary, Alberta, Canada (Recruiting)
• Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC) — Surrey, British Columbia, Canada (Recruiting)
• Carbonear General Hospital — Carbonear, Newfoundland and Labrador, Canada (Recruiting)

Study contacts

• Principal investigator: Joshua Rash, PhD — Memorial University of Newfoundland
• Study coordinator: Joshua Rash, PhD

Conditions Chronic Pain