Oxytocin for Acute Pain

Overseen By James C Eisenach, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must not be taking: Benzodiazepines, Pain medications, SSRIs, others

Disqualifiers: Nasal surgery, Diabetes, Pregnancy, 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: 4

Duration: 2 visits

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well oxytocin, known for its role in childbirth, can reduce pain when administered through an IV or nasal spray. Researchers aim to compare different forms of oxytocin and determine whether factors like age, weight, or sex affect its effectiveness. Participants will experience controlled heat on their skin and rate their pain levels before and after treatment. The trial seeks generally healthy individuals who do not have chronic pain, have not had recent nasal surgery, and are not using certain medications regularly. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are taking certain medications like benzodiazepines, pain medications, or specific drugs like SSRIs, MAOIs, or diuretics, you may not be eligible to participate in the trial. The protocol does not specify a washout period, but you should discuss your current medications with the study team to see if they affect your eligibility.

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

Research has shown that oxytocin might be safe for humans, particularly for pain management. In one study, inhaling oxytocin reduced post-surgery pain without causing harmful effects or altering blood pressure. Another study found that using oxytocin as a nasal spray helped lower pain sensitivity.

While these results are encouraging, this trial remains in the early stages. Researchers are closely monitoring how well participants tolerate the treatment and whether any side effects occur. Oxytocin has been used in other medical contexts, which is reassuring, but each new trial provides further insight into its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about oxytocin for acute pain because it offers a unique approach compared to standard pain treatments like NSAIDs and opioids. Unlike these common pain relievers that mostly target inflammation and pain receptors, oxytocin is a hormone that may influence pain pathways by affecting emotional and social bonding centers in the brain. This could mean not only managing pain differently but potentially reducing the need for traditional pain medications, which often come with significant side effects and addiction risks. Moreover, oxytocin is administered intranasally, providing a non-invasive and potentially quicker way to access its effects. This novel mechanism and delivery method set oxytocin apart as a promising alternative in pain management.

What evidence suggests that oxytocin might be an effective treatment for acute pain?

This trial will compare the effects of oxytocin administered intravenously and intranasally. Research has shown mixed results regarding oxytocin's effectiveness for pain relief. Some studies suggest that inhaling oxytocin can reduce post-surgery pain and lessen the need for painkillers like opioids. Other research indicates that oxytocin might lower sensitivity to pain, particularly for back and stomach pain. However, a review of three studies found no significant decrease in pain levels with oxytocin. Overall, its potential as a pain reliever remains under investigation, with some hopeful signs but no clear consensus yet. ^{1 3 6 7 8}

Who Is on the Research Team?

James C Eisenach, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55 with a BMI under 40. It's not for those allergic to oxytocin or latex, pregnant or nursing women, anyone with certain heart conditions, at risk of low sodium levels, recent nasal surgery patients, chronic pain sufferers, diabetics, or daily users of benzodiazepines/pain meds.

Inclusion Criteria

Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3.

I am between 18 and 55 years old with a BMI under 40.

Exclusion Criteria

Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection)

Latex allergy

I have had low sodium levels or am at risk due to certain medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Training

Participants are trained to consistently rate pain from an FDA-approved device to test heat pain

1 visit

1 visit (in-person)

Treatment

Participants receive intravenous and intranasal administration of oxytocin or placebo and undergo heat testing

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin

Trial Overview The study tests how well oxytocin reduces pain when given as an IV and nasal spray. Participants will rate their pain after exposure to heat on the skin before and after receiving treatments across two visits. The effect of age, weight, and sex on the drug's efficacy will also be evaluated.

How Is the Trial Designed?

Group I: Intravenous (IV) placebo and intranasal (IN) oxytocin first Experimental Treatment 4 Interventions

On Visit 2 participant will receive IV infusion of placebo. At the beginning of the IV infusion, the participants will self-administer IN oxytocin. On Visit 3 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo.

Group II: Intravenous (IV) oxytocin and intranasal (IN) placebo first Experimental Treatment 4 Interventions

On Visit 2 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo. On Visit 3 participants will receive IV infusion of placebo. At the beginning of the IV infusion, the participant will self-administer IN oxytocin..

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405603025000342

Efficacy of perioperative inhalational oxytocin on ... Inhalational oxytocin effectively reduced postoperative pain and opioid requirements without affecting hemodynamic stability or causing adverse events.

3. tandfonline.com tandfonline.com/doi/abs/10.1080/24740527.2023.2191114

Evaluating the efficacy of oxytocin for pain management Narrative review provided encouraging evidence that exogenous oxytocin administration reduced pain sensitivity among individuals with back pain, abdominal pain, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4276444/

Oxytocin – A Multifunctional Analgesic for Chronic Deep ... For example, one study found that intrathecal OXY administration resulted in a dose-dependent reduction of pain in a placebo-controlled evaluation of men and ...

5. hhp.ufl.edu hhp.ufl.edu/cuddle-hormone-oxytocin-may-provide-pain-relief-and-help-curb-harmful-opioid-use/

Cuddle hormone oxytocin may provide pain relief and help ... A two-year interdisciplinary study at UF examines synthetic oxytocin's potential as an alternate pain management option for older adults. by Alisha Katz, APR.

6. tandfonline.com tandfonline.com/doi/full/10.1080/24740527.2023.2191114

Evaluating the efficacy of oxytocin for pain management The authors concluded that the use of oxytocin as an analgesic for acute pain in animals was supported. Moreover, preliminary research suggested that oxytocin ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02550093

The Effect of Intranasal Oxytocin on Pain Sensitivity and ... The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain. Few studies have demonstrated an association between ...

8. mdpi.com mdpi.com/2076-3425/13/12/1689

Intranasal Oxytocin and Pain Reduction: Testing a Social ... Following oxytocin administration, participants reported increased prosocial cognition and decision-making. Pain perception appeared to be adaptive, with ...