RecruitingEarly Phase 1NCT04218409

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


Sponsor

University of Florida

Enrollment

45 participants

Start Date

Sep 2, 2021

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, 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.


Eligibility

Min Age: 21 YearsMax Age: 45 Years

Inclusion Criteria6

  • Individuals fluent in English will participate.
  • Must report recreational use of opioids.
  • 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 Criteria5

  • Significant current physical disease or major psychiatric disorder.
  • No self-reported current interest in drug abuse treatment.
  • Women who are pregnant or nursing.
  • Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
  • Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.

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Interventions

DRUGOxyCODONE 5 mg Oral Tablet

Oral oxycodone 5 mg orally

DRUGOxytocin nasal spray

Intranasal oxytocin administration (48 IU)

OTHERPlacebo Oxycodone

Oxycodone 0 mg orally

OTHERPlacebo oxytocin

Intranasal placebo administration

DRUGOxyCODONE 2.5 mg Oral Tablet

Oral oxycodone 2.5 mg orally


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT04218409


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