NCT05761860

The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 45 Years – 85 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, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.

Detailed description

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. 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 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	Oxycodone 5mg oral administration
DRUG	OxyCODONE 2.5 mg Oral Tablet	Oxycodone 2.5mg oral administration
OTHER	Placebo oxyCODONE Oral Tablet	Oxycodone 0mg (placebo) oral administration
DRUG	Oxytocin Nasal Spray (48 IU)	Intranasal oxytocin administration (48 IU)
OTHER	Placebo Oxytocin Nasal Spray	Intranasal oxytocin placebo administration

Timeline

• Start date: 2023-09-12
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2023-03-09
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study