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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04218409
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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

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, 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.

Key Dates

Start date
Sep 2, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FL

Related Studies