Oxytocin Nasal Spray for Chronic Pain

Recruiting at 2 trial locations

Overseen By David Flusk

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Memorial University of Newfoundland

Must be taking: Pain management

Must not be taking: Nasal sprays

Disqualifiers: Pregnancy, Cancer, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a nasal spray containing oxytocin, a natural hormone, to determine its effectiveness in managing chronic pain. Participants use the nasal spray twice daily, with varying doses of oxytocin tested alongside a placebo (a spray with no active ingredient). The goal is to assess whether oxytocin can reduce pain and improve daily functioning. Eligible participants should have long-term nerve, muscle, or pelvic pain and must have been on stable pain medication for at least three months. The trial takes place in Vancouver, Calgary, and St. John's, aiming to offer new options for managing chronic pain effectively. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of new pain management options.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you have been on stable medication for pain management for at least 3 months and that there are no anticipated changes during the 10 weeks of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using oxytocin as a nasal spray is generally safe. In earlier studies, older men who used a 24-IU dose found it safe and experienced no serious side effects. These findings encourage further research with diverse groups.

While less information exists about the 48-IU dose, it is under study to determine its safety and effectiveness in managing pain. Since the body naturally produces oxytocin, this contributes to its safety profile.

Overall, current research suggests that oxytocin nasal spray could be a promising method for managing chronic pain with minimal safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Oxytocin nasal spray is unique because it explores a new way to manage chronic pain by leveraging oxytocin, a hormone better known for its role in social bonding and childbirth. Unlike conventional pain treatments like opioids, which can have significant side effects and addiction risks, oxytocin offers a potentially safer option with a different mechanism, possibly affecting pain perception through emotional and social pathways. Additionally, its nasal spray delivery method provides a non-invasive and easy-to-use alternative, which could lead to more convenient and immediate pain relief. Researchers are excited about this approach because it could offer a novel, less addictive way to treat chronic pain, addressing a critical need in pain management.

What evidence suggests that oxytocin nasal spray might be an effective treatment for chronic pain?

Research shows that oxytocin, a hormone naturally produced in the body, might help manage chronic pain. Studies have found that oxytocin can reduce pain sensitivity in conditions like chronic back pain and headaches. Although a review of some studies did not find a significant decrease in pain intensity with oxytocin, research continues. In this trial, participants will receive nasal spray treatments with either 24-IU or 48-IU doses of oxytocin, or a placebo. The goal is to determine if these oxytocin doses provide relief compared to the placebo (a substance with no active drug). ^{2 4 6 7 8}

Who Is on the Research Team?

Joshua Rash, PhD

Principal Investigator

Memorial University of Newfoundland

Are You a Good Fit for This Trial?

Adult men and premenopausal women with chronic pain in muscles, nerves, or the pelvic region can join this trial. They must have moderate pain levels and be on stable pain medication for at least 3 months. Participants should not be pregnant, planning pregnancy, or have significant depression or certain medical conditions like heart issues or nasal pathology.

Inclusion Criteria

My pain level is moderate, between 4 and 8 on a scale of 10.

I have been on a stable pain medication plan for 3+ months with no changes expected.

I have primary pain in my back, neck, or shoulder.

Exclusion Criteria

I have diabetes insipidus.

You are allergic to oxytocin.

I have or had cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three 2-week interventions using intranasal oxytocin or placebo, with a 2-week wash-out period between each intervention

10 weeks

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 24-IU oxytocin
• 48-IU oxytocin
• Placebo

Trial Overview The study tests if a nasal spray containing oxytocin can improve chronic pain management compared to a placebo. Participants will use two different doses of oxytocin sprays and one placebo spray across three sessions without knowing which they're receiving. Their daily pain and function ratings will help determine the effectiveness of oxytocin.

How Is the Trial Designed?

Group I: Crossover sequence 2: placebo first Experimental Treatment 3 Interventions

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

Group II: Crossover sequence 1: Oxytocin first Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Memorial University of Newfoundland

Lead Sponsor

Trials

73

Recruited

1,836,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A study involving 108 patients with severe postepisiotomy pain found that both 25 mg and 50 mg doses of ketoprofen were effective in providing pain relief, showing similar efficacy to 500 mg of dipyrone.

All active treatments significantly outperformed placebo, with over 75% of patients in the active groups rating their pain relief as 'good' or 'excellent', and no adverse events were reported, indicating a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of liquid ketoprofen compared to liquid dipyrone and placebo administered orally as drops in postepisiotomy pain. Olson, NZ., Sunshine, A., Zighelboim, I., et al.[2015]

In a pilot study involving 24 gynecological patients, nasal fentanyl spray provided rapid and effective postoperative pain relief comparable to intravenous fentanyl, with analgesia onset within 5 minutes.

Both formulations of nasal fentanyl were generally well-tolerated, with no significant differences in side effects compared to intravenous administration, although a majority of patients still preferred the intravenous route.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new formulation of nasal fentanyl spray for postoperative analgesia: a pilot study. Paech, MJ., Lim, CB., Banks, SL., et al.[2019]

The FDA has approved a new nasal spray formulation of fentanyl, called Lazanda-Archimedes, specifically for managing breakthrough pain in adult cancer patients who are already tolerant to opioid therapy.

This approval adds to the existing forms of fentanyl available in the US, which include intravenous, intrathecal, epidural, transdermal, and oral transmucosal options, providing more flexibility in pain management for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fentanyl nasal spray (Lazanda) for pain. [2013]

Fentanyl-TTS (transdermal system) effectively manages postoperative pain, providing continuous analgesic release for 72 hours, although patients may require additional analgesics during the first 12 hours due to a lag in effect.

While fentanyl-TTS shows efficacy, it carries a risk of respiratory depression in up to 9% of patients, along with other side effects like nausea (62%) and local skin reactions (39%), highlighting the need for careful monitoring during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fentanyl-TTS for postoperative pain therapy. A new alternative?]. Donner, B., Zenz, M., Tryba, M., et al.[2013]

Transnasal butorphanol (TB) significantly improved pain relief measures, such as the visual analogue scale (VAS) and Clinical Global Impression scores, in patients after uvulopalatopharyngoplasty (UPPP) for obstructive sleep apnea, indicating its efficacy for postoperative pain management.

The study demonstrated that TB is safe for use in patients undergoing oropharyngeal surgery, with no major complications reported during the trial involving 12 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal butorphanol for pain relief after uvulopalatopharyngoplasty - a hospital-based,randomized study. Huang, HC., Lee, LA., Fang, TJ., et al.[2013]

Intranasal fentanyl is rapidly absorbed and offers a promising method for pain management, particularly for breakthrough pain in cancer patients, with advantages over oral forms such as faster onset and easier administration.

New formulations of fentanyl nasal sprays, like PecFent and Instanyl, are designed to minimize runoff and improve absorption, making them more effective while also requiring lower volumes for effective dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal delivery of fentanyl. Watts, P., Smith, A., Perelman, M.[2018]

Intranasal ketorolac has been shown to significantly reduce pain in adult patients, with one phase III study reporting a mean pain intensity difference score of 83.3 compared to 37.2 for placebo, indicating its efficacy as a non-opioid analgesic.

The drug is well-tolerated, with most adverse events related to the administration route, and it has a rapid absorption time of 0.50-0.75 hours, making it a viable option for short-term pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of intranasal ketorolac tromethamine for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. He, A., Hersh, EV.[2013]

Intranasal fentanyl spray (INFS) provided significantly faster 'meaningful' pain relief for cancer-related breakthrough pain compared to oral transmucosal fentanyl citrate (OTFC), with a median onset time of 11 minutes for INFS versus 16 minutes for OTFC.

Patients preferred INFS over OTFC due to its ease of use and effectiveness, achieving greater pain intensity reductions at earlier time points, while both treatments were well tolerated with nausea being the most common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Mercadante, S., Radbruch, L., Davies, A., et al.[2014]

Using Merocele nasal packs soaked with levobupivacaine significantly reduced postoperative pain levels in patients after septoplasty compared to saline-soaked packs, as measured by visual analogue scale (VAS) scores at multiple time points up to 12 hours post-surgery.

Patients receiving levobupivacaine required less supplemental analgesia, indicating that this method not only alleviates pain effectively but also enhances overall patient comfort after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. Yilmaz, S., Kocaman Akbay, B., Yildizbaş, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04903002

Evaluating the Efficacy of Intranasal Oxytocin on Chronic ... Goals / Research Aim: To evaluate the efficacy of intranasal OT as an adjuvant treatment to improve pain and function among men and women with chronic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187080/

Evaluating the efficacy of oxytocin for pain management Meta-analysis of three studies indicated that exogenous oxytocin administration did not result in a significant reduction in pain intensity ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34556520/

Evaluating the efficacy of intranasal oxytocin on pain and ... The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04903002/evaluating-the-efficacy-of-intranasal-oxytocin-on-chronic-pain

Evaluating the Efficacy of Intranasal Oxytocin on Chronic ... 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.

5. bmjopen.bmj.com bmjopen.bmj.com/content/7/4/e014909

Protocol for a placebo-controlled, within-participants ... Thus far, oxytocin administration has been reported to lower pain sensitivity among patients experiencing chronic back pain,19 headache,20 constipation21 and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8115997/

Safety and tolerability of chronic intranasal oxytocin in older men Chronic intranasal OT appears safe and well-tolerated in generally healthy older men. These findings provide support for continued human research.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10398562241291335

Oxytocin in old age psychiatry: A systematic review of the ... 24 IU intranasal oxytocin, twice daily, for 4 weeks, Study data supported that the chronic OT administration was safe and well-tolerated in ...

8. nature.com nature.com/articles/s41380-020-00864-7

Advances in the field of intranasal oxytocin research In this review we outline recent advances from human and animal research that provide converging evidence for functionally relevant effects of the intranasal ...