An Early Phase 1 interventional study of OxyCODONE 5 mg Oral Tablet and Oxytocin nasal spray in Pain, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by University of Florida · Early Phase 1, Interventional, and Basic science
Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.
The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 45 is below the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion criteria:
Combined effects of oxycodone and oxytocin
Drug: OxyCODONE 5 mg Oral Tablet · Drug: Oxytocin nasal spray
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Drug: OxyCODONE 5 mg Oral Tablet · Other: Placebo oxytocin
Separate effects of oxytocin. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Drug: Oxytocin nasal spray · Other: Placebo Oxycodone
Serves as the control
Other: Placebo Oxycodone · Other: Placebo oxytocin
Combined effects of oxycodone and oxytocin
Drug: Oxytocin nasal spray · Drug: OxyCODONE 2.5 mg Oral Tablet
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Other: Placebo oxytocin · Drug: OxyCODONE 2.5 mg Oral Tablet
Oral oxycodone 5 mg orally
Intranasal oxytocin administration (48 IU)
Oxycodone 0 mg orally
Intranasal placebo administration
Oral oxycodone 2.5 mg orally
Subject-rated abuse liability
Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 4 sessions due to a minimum of a one week washout period in between each session.
Time frame: up to 6 weeks.
Plan to share: No
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