Evaluating the effects of oxytocin on pain relief and opioid use
Official title: Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
Run by University of Florida · NCT04218409 · Data updated 2026-11-12
This study is testing if oxytocin can make oxycodone work better for pain relief and help reduce the chances of misuse for people who need pain management.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | September 2, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT04218409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy individuals who have reported recreational use of opioids and are not currently experiencing chronic pain.
✕Probably not a fit
Patients with significant physical diseases, major psychiatric disorders, or current chronic pain conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the potential of oxytocin to enhance the pain-reducing effects of oxycodone while potentially lowering its abuse liability. Participants will engage in a series of laboratory sessions where they will self-administer intranasal oxytocin or a placebo shortly after taking oral oxycodone or a placebo. The study employs a double-blind, randomized, placebo-controlled design to assess the effects on experimentally-induced pain, subjective experiences, and neural activation. The research aims to uncover the neurobehavioral mechanisms that contribute to individual differences in response to these substances.
Why it matters
Potential benefit: If successful, this study could lead to safer pain management strategies that reduce reliance on opioids.
How similar studies have gone: While the combination of oxytocin and opioids is a novel approach, previous studies have suggested potential benefits of oxytocin in pain management, indicating a promising area of exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals fluent in English will participate. * Must report recreational use of opioids. * Be within 20% of their ideal body weight. * Are not currently experiencing chronic pain (pain on most days during the past 3 months) * Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute. * Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications. Exclusion criteria: * Significant current physical disease or major psychiatric disorder. * No self-reported current interest in drug abuse treatment. * Women who are pregnant or nursing. * Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine. * Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.
Where it's running
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University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Meredith Berry, PhD — University of Florida
- Study coordinator: Lauren Nieder
- Email: lauren.nieder@ufl.edu
- Phone: 352-294-1067
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.