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

NCT05761860 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB2023004355R21DA056813-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Abuse liability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Oral oxycodone (5mg) + intranasal oxytocin (48 IU)

ACTIVE COMPARATOR

Combined effects of oxycodone and oxytocin.

Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU)

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)

ACTIVE COMPARATOR

Combined effects of oxycodone and oxytocin.

Drug: OxyCODONE 2.5 mg Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU)

Oral placebo + intranasal oxytocin (48 IU)

ACTIVE COMPARATOR

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.

Other: Placebo oxyCODONE Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU)

Oral oxycodone (5mg) + intranasal placebo

ACTIVE COMPARATOR

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 Nasal Spray

Oral oxycodone (2.5mg) + intranasal placebo

ACTIVE COMPARATOR

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; Other: Placebo Oxytocin Nasal Spray

Oral placebo + intranasal placebo

SHAM COMPARATOR

Serves as the control.

Other: Placebo oxyCODONE Oral Tablet; Other: Placebo Oxytocin Nasal Spray

Interventions

OxyCODONE 5 mg Oral Tablet DRUG

Oxycodone 5mg oral administration

Oral oxycodone (5mg) + intranasal oxytocin (48 IU); Oral oxycodone (5mg) + intranasal placebo

OxyCODONE 2.5 mg Oral Tablet DRUG

Oxycodone 2.5mg oral administration

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); Oral oxycodone (2.5mg) + intranasal placebo

Placebo oxyCODONE Oral Tablet OTHER

Oxycodone 0mg (placebo) oral administration

Oral placebo + intranasal oxytocin (48 IU); Oral placebo + intranasal placebo

Oxytocin Nasal Spray (48 IU) DRUG

Intranasal oxytocin administration (48 IU)

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); Oral oxycodone (5mg) + intranasal oxytocin (48 IU); Oral placebo + intranasal oxytocin (48 IU)

Placebo Oxytocin Nasal Spray OTHER

Intranasal oxytocin placebo administration

Oral oxycodone (2.5mg) + intranasal placebo; Oral oxycodone (5mg) + intranasal placebo; Oral placebo + intranasal placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Meredith S Berry, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren E Nieder, MSPH

CONTACT

(352) 294-1067; lauren.nieder@ufl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a within-participant study so that each participant receives all conditions.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)