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

Overview

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.

Interventions

• Drug OxyCODONE 5 mg Oral Tablet
  Oral oxycodone 5 mg orally
• Drug Oxytocin nasal spray
  Intranasal oxytocin administration (48 IU)
• Other Placebo Oxycodone
  Oxycodone 0 mg orally
• Other Placebo oxytocin
  Intranasal placebo administration
• Drug OxyCODONE 2.5 mg Oral Tablet
  Oral oxycodone 2.5 mg orally

Primary outcome measures

• Subject-rated abuse liability [Time frame: up to 6 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT04218409 · IRB201902618-N · OCR30384 · 1K01DA052673-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗