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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU); Drug: OxyCODONE 2.5 mg Oral Tablet; Other: Placebo oxyCODONE Oral Tablet; Other: Placebo Oxytocin Nasal Spray

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Lauren E Nieder, MSPH; Phone Number: (352) 294-1067; Email: lauren.nieder@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
      • Contact: Lauren E Nieder, MSPH; Phone Number: 352-294-1067; Email: lauren.nieder@ufl.edu
      • Principal Investigator: Meredith S Berry, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral oxycodone (5mg) + intranasal oxytocin (48 IU); Combined effects of oxycodone and oxytocin.	Drug: OxyCODONE 5 mg Oral Tablet; Oxycodone 5mg oral administration; Drug: Oxytocin Nasal Spray (48 IU); Intranasal oxytocin administration (48 IU)
Active Comparator: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); Combined effects of oxycodone and oxytocin.	Drug: Oxytocin Nasal Spray (48 IU); Intranasal oxytocin administration (48 IU); Drug: OxyCODONE 2.5 mg Oral Tablet; Oxycodone 2.5mg oral administration
Active Comparator: Oral placebo + intranasal oxytocin (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.	Drug: Oxytocin Nasal Spray (48 IU); Intranasal oxytocin administration (48 IU); Other: Placebo oxyCODONE Oral Tablet; Oxycodone 0mg (placebo) oral administration
Active Comparator: Oral oxycodone (5mg) + intranasal placebo; 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; Oxycodone 5mg oral administration; Other: Placebo Oxytocin Nasal Spray; Intranasal oxytocin placebo administration
Active Comparator: Oral oxycodone (2.5mg) + intranasal placebo; 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 2.5 mg Oral Tablet; Oxycodone 2.5mg oral administration; Other: Placebo Oxytocin Nasal Spray; Intranasal oxytocin placebo administration
Sham Comparator: Oral placebo + intranasal placebo; Serves as the control.	Other: Placebo oxyCODONE Oral Tablet; Oxycodone 0mg (placebo) oral administration; Other: Placebo Oxytocin Nasal Spray; Intranasal oxytocin placebo administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 sessions due to a minimum of a one week washout period in between each session.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Meredith S Berry, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Abuse liability
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Dosage Forms; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Oxycodone; Tablets
• Other Study ID Numbers: IRB202300435; 5R21DA056813-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No