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NCT Number: NCT04218409

Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination

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.

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

About this study

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. 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 MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OxyCODONE 5 Mg Oral Tablet

Drug

Oral oxycodone 5 mg orally

Oxytocin nasal spray

Drug

Intranasal oxytocin administration (48 IU)

Placebo Oxycodone

Other

Oxycodone 0 mg orally

Placebo oxytocin

Other

Intranasal placebo administration

OxyCODONE 2.5 mg Oral Tablet

Drug

Oral oxycodone 2.5 mg orally

Primary outcomes

  1. Subject-rated abuse liability

    Time frame: 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 4 sessions due to a minimum of a one week washout period in between each session.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Nieder

CONTACT

[email protected]

352-294-1067

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2020
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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