Recruiting
Early Phase 1

Oxytocin

Sponsor:

University of Florida

Code:

NCT05761860

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

OxyCODONE 5 mg Oral Tablet

OxyCODONE 2.5 mg Oral Tablet

Placebo oxyCODONE Oral Tablet

Oxytocin Nasal Spray (48 IU)

Placebo Oxytocin Nasal Spray

Study Details

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

Study ID

NCT05761860

Start date

Sep 12, 2023

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Oral oxycodone (5mg) + intranasal oxytocin (48 IU)

Combined effects of oxycodone and oxytocin.

active comparator: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)

Combined effects of oxycodone and oxytocin.

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.

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.

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.

sham comparator: Oral placebo + intranasal placebo

Serves as the control.

Interventions

OxyCODONE 5 mg Oral Tablet

Oxycodone 5mg oral administration

OxyCODONE 2.5 mg Oral Tablet

Oxycodone 2.5mg oral administration

Placebo oxyCODONE Oral Tablet

Oxycodone 0mg (placebo) oral administration

Oxytocin Nasal Spray (48 IU)

Intranasal oxytocin administration (48 IU)

Placebo Oxytocin Nasal Spray

Intranasal oxytocin placebo administration

Primary outcome measure

  • Subject-rated abuse liability [ Time Frame: Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Lauren E Nieder, MSPH

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

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Lauren E Nieder, MSPH

352-294-1067lauren.nieder@ufl.edu

Principal Investigator:

Meredith S Berry, PhD

More Information

Sponsor

University of Florida

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Pain
  • Abuse liability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-01.