Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain

Living with long-term pain can be really tough, affecting how you feel and what you can do each day. Current treatments don't always work well and can have side effects. This study is testing a new approach: a nasal spray containing oxytocin, a natural substance already in your body. We believe it might help manage various types of long-term pain, like nerve, muscle, or pelvic pain. Participants will try different doses of the oxytocin spray and a dummy spray, without knowing which is which. The goal is to see if oxytocin can significantly reduce pain and improve daily function compared to the dummy spray, offering a new, non-addictive treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Memorial University of Newfoundland

Enrolment target

336

Start

01 Apr 2022

Estimated completion

31 Mar 2026

Chronic Pain

What is this study about?

Many people in the UK live with long-term pain, which means pain that has lasted for more than three months. This kind of pain can really impact your physical health, your mood, and your overall quality of life. Often, current treatments don't fully relieve the pain and can sometimes come with unwanted side effects. Because of this, there's a real need to find new and better ways to help people manage their pain.

This research project is looking into whether a nasal spray containing something called oxytocin could be helpful. Oxytocin is a natural chemical made in your body, and early research in animals suggests it might play a role in how pain signals are processed. This study aims to find out if using an oxytocin nasal spray can make a real difference for men and women experiencing long-term pain.

We're testing different amounts of oxytocin in the nasal spray to see which dose might be most effective. Participants will use either a small dose of oxytocin, a medium dose, or a spray with no active medicine (often called a 'placebo' or 'dummy' spray). This helps us understand if any improvements are genuinely due to the oxytocin or simply the act of using a spray. Neither the participants nor the researchers will know who is getting which spray at the time, which helps keep the results fair. We hope that this research will lead to new ways to improve the lives of people with long-term pain.

Key takeaways

The study explores a new nasal spray for long-term pain.
It uses oxytocin, a natural body chemical, in different doses.
Participants will use a spray twice daily for two weeks, followed by a break.
The study aims to improve pain and daily function.
Results could offer a new, non-addictive pain management option.
You'll keep a daily diary to track your pain and activity levels.

Who may be eligible?

This study is looking for men and women over 18 years old who are experiencing long-term pain. You'll need to have been on the same pain medication for at least three months, with no plans to change it during the study. Your pain level should be moderate, scoring between 4 and 8 on a scale of 0 to 10.

Importantly, the study is focusing on specific types of pain for different locations: those with nerve pain (neuropathic pain) from the Vancouver area, women with chronic pelvic muscle pain from Calgary (who haven't had a hysterectomy and don't have certain other pain conditions like endometriosis or fibromyalgia), and men and women with long-term back, neck, or shoulder pain from Carbonear.

There are also some reasons why you wouldn't be able to join. For instance, if you are pregnant or planning to be, currently use another nasal spray, have a nose condition, have diabetes insipidus, a history of cancer, or ongoing serious mental health issues that aren't managed well.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Has your pain lasted more than 3 months and is it moderate (4-8 out of 10)?
Have you been on stable pain medication for at least 3 months?
Do you have nerve pain, pelvic muscle pain (women only, specific criteria), or back, neck, or shoulder pain (depending on location)?
Are you not pregnant or planning to be, and not using another nasal spray?
Do you not have a history of cancer or serious uncontrolled mental health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll go through three separate study periods, each lasting two weeks. During each two-week period, you'll use a nasal spray twice a day. The three types of sprays will include a small dose of oxytocin, a medium dose, and a spray with no active medicine (a placebo). You won't know which spray you're using at any given time, and neither will the study team, to keep things fair.

After each two-week spray period, there will be a two-week break where you don't use the study spray. This break, called a 'washout' period, allows any effects of the previous spray to wear off before you start the next one. During the study, you'll be asked to keep a daily diary, rating your pain and how well you're able to do your usual activities. The total duration of your active involvement in the study, including the spray periods and the washout periods, will be around 10 weeks.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You might experience less pain and an improvement in your daily activities if the oxytocin nasal spray works for you. You'll also be contributing to important research that could lead to new treatments for long-term pain, potentially helping many others in the future. As with any medication, there's always a chance of side effects, but oxytocin is a natural body chemical, and the doses being tested are carefully considered. We don't expect major risks, but any potential side effects will be fully explained to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Calgary Chronic Pain Centre
Verified postcode
Calgary, Canada
Jim Pattison Outpatient Care & Surgical Centre Pain Clinic (JPOCSC-PC)
Verified postcode
Surrey, Canada
Carbonear General Hospital
Verified postcode
Carbonear, Canada

Common questions

What is oxytocin?

Oxytocin is a hormone naturally made in your body that plays a role in feelings and some body functions. This study is exploring if it can also help with pain.

What is a 'placebo' or 'dummy spray'?

A placebo spray looks and feels like the real thing but contains no active medicine. It helps us see if any changes are truly due to the oxytocin.

Will I know if I'm getting the actual treatment?

No, neither you nor the study team will know which spray you are using at any time. This is called 'blinding' and helps keep the study fair and results accurate.

How long will I be in the study?

Your active participation, including spray periods and breaks, will last about 10 weeks in total.

Can I stop participating if I want to?

Yes, you are free to leave the study at any point, and it won't affect your ongoing medical care.