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

Early Phase 1

Recruiting

• Conditions: Pain
• Interventions: Drug: OxyCODONE 2.5 mg Oral Tablet; Drug: OxyCODONE 5 mg Oral Tablet; Other: Placebo oxyCODONE Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU); Other: Placebo Oxytocin Nasal Spray

• Registration Number: NCT05761860
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Study Start: 2023-09-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral oxycodone (5mg) + intranasal oxytocin (48 IU)	Oxytocin Nasal Spray (48 IU)	Combined effects of oxycodone and oxytocin.
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)	Oxytocin Nasal Spray (48 IU)	Combined effects of oxycodone and oxytocin.
Oral placebo + intranasal oxytocin (48 IU)	Oxytocin Nasal Spray (48 IU)	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.
Oral oxycodone (2.5mg) + intranasal placebo	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.
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)	OxyCODONE 2.5 mg Oral Tablet	Combined effects of oxycodone and oxytocin.
Oral oxycodone (5mg) + intranasal placebo	OxyCODONE 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.
Oral placebo + intranasal placebo	Placebo oxyCODONE Oral Tablet	Serves as the control.
Oral placebo + intranasal oxytocin (48 IU)	Placebo oxyCODONE Oral Tablet	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.
Oral oxycodone (5mg) + intranasal oxytocin (48 IU)	OxyCODONE 5 mg Oral Tablet	Combined effects of oxycodone and oxytocin.
Oral oxycodone (2.5mg) + intranasal placebo	Placebo 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.
Oral oxycodone (5mg) + intranasal placebo	Placebo 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.
Oral placebo + intranasal placebo	Placebo Oxytocin Nasal Spray	Serves as the control.

Primary Outcome Measures

Name	Time	Method
Subject-rated abuse liability	Up to 6 weeks	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 6 sessions due to a minimum of a one week washout period in between each session.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States