Using oxytocin to reduce pain and opioid abuse in older adults
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
This study is testing if giving oxytocin with oxycodone can help older adults feel less pain and reduce the risk of misusing the opioid.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05761860 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oxytocin when administered alongside oxycodone to determine if it can lower the abuse potential of the opioid while enhancing pain relief. Participants will self-administer intranasal oxytocin or a placebo shortly after taking oral oxycodone or a placebo in a controlled laboratory setting. The study will involve six sessions where the effects on pain, subjective experiences, and decision-making will be evaluated. The research aims to provide insights into the safety and efficacy of combining these substances in a non-residential, double-blind, randomized format.
Who should consider this trial
Good fit: Ideal candidates are older adults who have previously used opioids but are not currently experiencing chronic pain.
Not a fit: Patients with significant physical diseases, major psychiatric disorders, or those currently interested in drug abuse treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer pain management strategies for older adults, reducing the risk of opioid abuse.
How similar studies have performed: While the combination of oxytocin and opioids is a novel approach, preliminary research suggests potential benefits, though this specific methodology has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals fluent in English will participate. * Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime). * 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 (uncontrolled) psychiatric disorder. * No self-reported current interest in drug abuse treatment. * Women who are pregnant or nursing. * Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Meredith S Berry, PhD — University of Florida
- Study coordinator: Lauren E Nieder, MSPH
- 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.