NCT04218409

Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	OxyCODONE 5 mg Oral Tablet	Oral oxycodone 5 mg orally
DRUG	Oxytocin nasal spray	Intranasal oxytocin administration (48 IU)
OTHER	Placebo Oxycodone	Oxycodone 0 mg orally
OTHER	Placebo oxytocin	Intranasal placebo administration
DRUG	OxyCODONE 2.5 mg Oral Tablet	Oral oxycodone 2.5 mg orally

Timeline

• Start date: 2021-09-02
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-01-06
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study