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

Purpose

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.

Condition

Pain

Eligibility

Eligible Ages: Between 21 Years and 45 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: Early Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a within-participant study so that each participant receives all conditions.
Primary Purpose: Basic Science
Masking: Double (Participant, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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 Oxycodone Oxycodone 0 mg orally Other: Placebo oxytocin Intranasal placebo administration
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

Recruiting Locations

University of Florida
Gainesville, Florida 32611

More Details

NCT ID: NCT04218409
Status: Recruiting
Sponsor: University of Florida

Study Contact

Lauren Nieder
352-294-1067
lauren.nieder@ufl.edu

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.