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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05761860
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 12, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Oral oxycodone (5mg) + intranasal oxytocin (48 IU)
    Combined effects of oxycodone and oxytocin.
  • Active Comparator: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)
    Combined effects of oxycodone and oxytocin.
  • Active Comparator: Oral placebo + intranasal oxytocin (48 IU)
    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.
  • 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: 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.
  • Sham Comparator: Oral placebo + intranasal placebo
    Serves as the control.

Primary Outcome Measure

Subject-rated abuse liability [ Time Frame: Up to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Lauren E Nieder, MSPH
[email protected]
352-294-1067
Meredith S Berry, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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