Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain

What Was Tested

The trial (phase 2, phase 3) is built around Oxytocin for chronic pain: fibromyalgia & crps.

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.

It had two arms (groups): Crossover sequence 1: Oxytocin first (other) and Crossover sequence 2: placebo first (other).

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

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

The registry classes the interventions as drug.

More on the Plan

Outcomes: As recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, the primary outcome is change in pain-intensity assessed using the Brief Pain Inventory obtained from daily diaries.

Conditions: Experimental 1: 2-week course of 24-IU intranasal OT administered twice daily.

Experimental 2: 2-week course of 48-IU intranasal OT administered twice daily.

Control: 2-week course of intranasal placebo.

Who Took Part

Enrollment: 336 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;. 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.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: positive urine pregnancy test or contemplating pregnancy;; concurrent use of another nasal spray;; nasal pathology (e.g., ears, nose, and throat diagnosis);.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-04-01 with completion listed for 2026-03-31.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pain intensity (time frame: Change from Day 1 to Day 14 of nasal spray administration). Pain-related interference (time frame: Change from Day 1 to Day 14 of nasal spray administration).

It also tracked 3 secondary outcomes, for example Emotional function, Sleep Disturbance and Global Impression of Change.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 336 people with chronic pain: fibromyalgia & crps.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Chronic pain: fibromyalgia & CRPS research.