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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxytocin nasal spray; Other: Placebo oxytocin; Other: Placebo Oxycodone; Drug: OxyCODONE 2.5 mg Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Lauren Nieder; Phone Number: 352-294-1067; Email: lauren.nieder@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oxycodone (5mg) + intranasal oxytocin (48 IU); Combined effects of oxycodone and oxytocin	Drug: OxyCODONE 5 mg Oral Tablet; Oral oxycodone 5 mg orally; Drug: Oxytocin nasal spray; Intranasal oxytocin administration (48 IU)
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	Drug: OxyCODONE 5 mg Oral Tablet; Oral oxycodone 5 mg orally; Other: Placebo oxytocin; Intranasal placebo administration
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	Drug: Oxytocin nasal spray; Intranasal oxytocin administration (48 IU); Other: Placebo Oxycodone; Oxycodone 0 mg orally
Sham Comparator: placebo+placebo; Serves as the control	Other: Placebo oxytocin; Intranasal placebo administration; Other: Placebo Oxycodone; Oxycodone 0 mg orally
Active Comparator: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); Combined effects of oxycodone and oxytocin	Drug: Oxytocin nasal spray; Intranasal oxytocin administration (48 IU); Drug: OxyCODONE 2.5 mg Oral Tablet; Oral oxycodone 2.5 mg orally
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	Other: Placebo oxytocin; Intranasal placebo administration; Drug: OxyCODONE 2.5 mg Oral Tablet; Oral oxycodone 2.5 mg orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-rated abuse liability	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.	up to 6 weeks.

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Meredith Berry, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Reproductive Control Agents; Oxytocics; Oxytocin; Oxycodone
• Other Study ID Numbers: IRB201902618-N; OCR30384 (Other Identifier: UF OnCore); 1K01DA052673-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No