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NCT Number: NCT05761860

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.

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Key information

Age range

45 year–85 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

Location contact

Lauren E Nieder, MSPH

CONTACT

[email protected]

352-294-1067

Meredith S Berry, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

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 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.

Treatment and study plan

OxyCODONE 5 Mg Oral Tablet

Drug

Oxycodone 5mg oral administration

OxyCODONE 2.5 mg Oral Tablet

Drug

Oxycodone 2.5mg oral administration

Placebo oxyCODONE Oral Tablet

Other

Oxycodone 0mg (placebo) oral administration

Oxytocin Nasal Spray (48 IU)

Drug

Intranasal oxytocin administration (48 IU)

Placebo Oxytocin Nasal Spray

Other

Intranasal oxytocin placebo administration

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 6 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 E Nieder, MSPH

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
2023
Primary completion
2026
Study completion
2027
First posted
Mar 9, 2023
Registry last updated
May 1, 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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