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

Early Phase 1

Recruiting

• Conditions: Pain
• Interventions: Drug: OxyCODONE 5 mg Oral Tablet; Other: Placebo Oxycodone; Other: Placebo oxytocin; Drug: Oxytocin nasal spray; Drug: OxyCODONE 2.5 mg Oral Tablet

• Registration Number: NCT04218409
• Lead Sponsor: University of Florida

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2021-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oxycodone (5mg) + intranasal oxytocin (48 IU)	Oxytocin nasal spray	Combined effects of oxycodone and oxytocin
oxytocin+placebo	Oxytocin nasal spray	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
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)	Oxytocin nasal spray	Combined effects of oxycodone and oxytocin
oxycodone (5mg) + intranasal oxytocin (48 IU)	OxyCODONE 5 mg Oral Tablet	Combined effects of oxycodone and oxytocin
placebo+placebo	Placebo Oxycodone	Serves as the control
Oral oxycodone (2.5mg) + intranasal placebo	Placebo oxytocin	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
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)	OxyCODONE 2.5 mg Oral Tablet	Combined effects of oxycodone and oxytocin
Oral oxycodone (5mg) + intranasal placebo	OxyCODONE 5 mg Oral Tablet	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
Oral oxycodone (5mg) + intranasal placebo	Placebo oxytocin	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
oxytocin+placebo	Placebo Oxycodone	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
placebo+placebo	Placebo oxytocin	Serves as the control
Oral oxycodone (2.5mg) + intranasal placebo	OxyCODONE 2.5 mg Oral Tablet	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 Measures

Name	Time	Method
Subject-rated abuse liability	up to 6 weeks.	Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 4 sessions due to a minimum of a one week washout period in between each session.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States