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NCT04218409EARLY_PHASE1RecruitingAccepts Healthy Volunteers

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

University of Florida

Start Date

9/2/2021

Completion Date

12/31/2026

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.

Detailed Description

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. 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 MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Eligibility Criteria

Age Range: 21 years to 45 years

Inclusion Criteria: * 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 criteria: * 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.

Interventions

DRUG

OxyCODONE 5 mg Oral Tablet

DRUG

Oxytocin nasal spray

OTHER

Placebo Oxycodone

OTHER

Placebo oxytocin

DRUG

OxyCODONE 2.5 mg Oral Tablet

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Conditions

Pain

Locations

University of Florida

Gainesville, Florida 32611

United States