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

NCT04218409 | Recruiting Early Phase 1 DMC FDA Drug

• 3 other identifiers: IRB201902618-NOCR303841K01DA052673-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (6)

oxycodone (5mg) + intranasal oxytocin (48 IU)

ACTIVE COMPARATOR

Combined effects of oxycodone and oxytocin

Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxytocin nasal spray

Oral oxycodone (5mg) + intranasal placebo

ACTIVE COMPARATOR

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; Other: Placebo oxytocin

oxytocin+placebo

ACTIVE COMPARATOR

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; Other: Placebo Oxycodone

placebo+placebo

SHAM COMPARATOR

Serves as the control

Other: Placebo Oxycodone; Other: Placebo oxytocin

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)

ACTIVE COMPARATOR

Combined effects of oxycodone and oxytocin

Drug: Oxytocin nasal spray; Drug: OxyCODONE 2.5 mg Oral Tablet

Oral oxycodone (2.5mg) + intranasal placebo

ACTIVE COMPARATOR

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; Drug: OxyCODONE 2.5 mg Oral Tablet

Interventions

OxyCODONE 5 mg Oral Tablet DRUG

Oral oxycodone 5 mg orally

Oral oxycodone (5mg) + intranasal placebo; oxycodone (5mg) + intranasal oxytocin (48 IU)

Oxytocin nasal spray DRUG

Intranasal oxytocin administration (48 IU)

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); oxycodone (5mg) + intranasal oxytocin (48 IU); oxytocin+placebo

Placebo Oxycodone OTHER

Oxycodone 0 mg orally

oxytocin+placebo; placebo+placebo

Placebo oxytocin OTHER

Intranasal placebo administration

Oral oxycodone (2.5mg) + intranasal placebo; Oral oxycodone (5mg) + intranasal placebo; placebo+placebo

OxyCODONE 2.5 mg Oral Tablet DRUG

Oral oxycodone 2.5 mg orally

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU); Oral oxycodone (2.5mg) + intranasal placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Meredith Berry, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Nieder

CONTACT

352-294-1067; lauren.nieder@ufl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a within-participant study so that each participant receives all conditions.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: September 2, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)