Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain

NCT04903002 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CIHR-PG#426528
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 3

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 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

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain severity index on the Brief Pain Inventory - Short Form (BPI-SF). Mean scores range from 0 to 10 with higher scores indicating greater pain.

  Change from Day 1 to Day 14 of nasal spray administration.

• Pain-related interference

  Pain interference index on the Brief Pain Inventory - Short Form (BPI-SF). Mean scores range from 0 to 10 with higher scores indicating greater pain-related interference.

  Change from Day 1 to Day 14 of nasal spray administration.

Secondary Outcomes (3)

• Emotional function

  Change from Day 1 to Day 14 of nasal spray administration.

• Sleep Disturbance

  Change from Day 1 to Day 14 of nasal spray administration.

• Global Impression of Change

  Rated at Day 14 of nasal spray administration

Study Arms (2)

Crossover sequence 1: Oxytocin first

OTHER

Patients receive 2-weeks courses of 24-IU oxytocin, placebo, 48-IU oxytocin.

Drug: 24-IU oxytocin; Drug: 48-IU oxytocin; Drug: Placebo

Crossover sequence 2: placebo first

OTHER

Patients receive 2-weeks courses of placebo, 24-IU oxytocin, 48-IU oxytocin.

Drug: 24-IU oxytocin; Drug: 48-IU oxytocin; Drug: Placebo

Interventions

24-IU oxytocin DRUG

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).

Crossover sequence 1: Oxytocin first; Crossover sequence 2: placebo first

48-IU oxytocin DRUG

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).

Crossover sequence 1: Oxytocin first; Crossover sequence 2: placebo first

Placebo DRUG

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.

Crossover sequence 1: Oxytocin first; Crossover sequence 2: placebo first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• University of Calgary: collaborator
• University of British Columbia: collaborator

Study Sites (3)

Calgary Chronic Pain Centre

Calgary, Alberta, T2T 5C7, Canada

Location

Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC)

Surrey, British Columbia, V3T0G9, Canada

Location

Carbonear General Hospital

Carbonear, Newfoundland and Labrador, A1Y 1A4, Canada

Location

Related Publications (1)

• Rash JA, Campbell TS, Cooper L, Flusk D, MacInnes A, Nasr-Esfahani M, Mekhael AA, Poulin PA, Robert M, Yi Y. 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. 2021 Sep 23;11(9):e055039. doi: 10.1136/bmjopen-2021-055039.

  PMID: 34556520 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Joshua Rash, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind study. In order to protect against expectation effects and biases, neither site investigators nor patients will know which nasal spray contains oxytocin or which sequence of conditions patients are assigned. The allocation sequence will be concealed from researchers using automated randomization. The bottles containing 24-IU oxytocin, 48-IU oxytocin, and placebo will be identical in appearance, smell, texture and taste, and only identifiable through a color labeling system known to the site pharmacists and study sponsor. Each site's randomization sequence will be accessed by the site pharmacist and bottles prepared accordingly. The RA assessing outcomes will be unaware of condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: April 1, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3-months after final follow-up (anticipated September 2024). Data will remain available for 25-years.

Locations

CA (3)