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

Last updated: April 21, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

1

Condition

Opioid Use Disorder

Pain

Treatment

OxyCODONE 2.5 mg Oral Tablet

Placebo oxyCODONE Oral Tablet

Oxytocin Nasal Spray (48 IU)

Clinical Study ID

NCT05761860
IRB202300435
5R21DA056813-02
  • Ages 45-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals fluent in English will participate.

  • Must report some experience with opioids (e.g., oxycodone, defined as use at leastonce 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 3months)

  • Have a systolic blood pressure of <=140 and diastolic blood pressure of <= 90, and aheart rate <= 90 beats per minute.

  • Participants must also have a normal electrocardiogram (EKG) reading and bloodworkindicating no major health contraindications.

Exclusion

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 clinicallysignificant withdrawal for any abused drug excluding nicotine and caffeine.

Study Design

Total Participants: 45
Treatment Group(s): 5
Primary Treatment: OxyCODONE 2.5 mg Oral Tablet
Phase: 1
Study Start date:
September 12, 2023
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32611
    United States

    Active - Recruiting

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