RecruitingEarly Phase 1NCT05761860

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


Sponsor

University of Florida

Enrollment

45 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

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Interventions

DRUGOxyCODONE 5 mg Oral Tablet

Oxycodone 5mg oral administration

DRUGOxyCODONE 2.5 mg Oral Tablet

Oxycodone 2.5mg oral administration

OTHERPlacebo oxyCODONE Oral Tablet

Oxycodone 0mg (placebo) oral administration

DRUGOxytocin Nasal Spray (48 IU)

Intranasal oxytocin administration (48 IU)

OTHERPlacebo Oxytocin Nasal Spray

Intranasal oxytocin placebo administration


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05761860


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