Evaluating the effects of oxytocin on pain relief and opioid use
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
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 |
| Enrollment | 45 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04218409 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals who have reported recreational use of opioids and are not currently experiencing chronic pain.
Not a fit: Patients with significant physical diseases, major psychiatric disorders, or current chronic pain conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.