Recruiting
Early Phase 1

Oxycodone with Oxytocin

Sponsor:

University of Florida

Code:

NCT04218409

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

Interventions

OxyCODONE 5 mg Oral Tablet

Oxytocin nasal spray

Placebo Oxycodone

Placebo oxytocin

OxyCODONE 2.5 mg Oral Tablet

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, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.

Conditions

Pain

Study ID

NCT04218409

Start date

Sep 2, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals fluent in English will participate.
  • Must report recreational use of opioids.
  • 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 psychiatric disorder.
  • No self-reported current interest in drug abuse treatment.
  • Women who are pregnant or nursing.
  • Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
  • Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

Combined effects of oxycodone and oxytocin

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: oxytocin+placebo

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

sham comparator: placebo+placebo

Serves as the control

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

Combined effects of oxycodone and oxytocin

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

Interventions

OxyCODONE 5 mg Oral Tablet

Oral oxycodone 5 mg orally

Oxytocin nasal spray

Intranasal oxytocin administration (48 IU)

Placebo Oxycodone

Oxycodone 0 mg orally

Placebo oxytocin

Intranasal placebo administration

OxyCODONE 2.5 mg Oral Tablet

Oral oxycodone 2.5 mg orally

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lauren Nieder

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

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

More Information

Sponsor

University of Florida

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

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 2026-01-14.