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

University of Florida

Status and phase: Enrolling; Early Phase 1

Conditions: Pain

Treatments: Drug: OxyCODONE 5 mg Oral Tablet; Other: Placebo oxytocin; Other: Placebo Oxycodone; Drug: Oxytocin nasal spray; Drug: OxyCODONE 2.5 mg Oral Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04218409

IRB201902618-N

1K01DA052673-01A1 (U.S. NIH Grant/Contract)

OCR30384 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 6 patient groups

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

Active Comparator group

Description:

Combined effects of oxycodone and oxytocin

Treatment:

Drug: Oxytocin nasal spray

Drug: OxyCODONE 5 mg Oral Tablet

Oral oxycodone (5mg) + intranasal placebo

Active Comparator group

Description:

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

Treatment:

Other: Placebo oxytocin

Drug: OxyCODONE 5 mg Oral Tablet

oxytocin+placebo

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Other: Placebo Oxycodone

placebo+placebo

Sham Comparator group

Description:

Serves as the control

Treatment:

Other: Placebo Oxycodone

Other: Placebo oxytocin

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

Active Comparator group

Description:

Combined effects of oxycodone and oxytocin

Treatment:

Drug: OxyCODONE 2.5 mg Oral Tablet

Drug: Oxytocin nasal spray

Oral oxycodone (2.5mg) + intranasal placebo

Active Comparator group

Description:

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

Treatment:

Drug: OxyCODONE 2.5 mg Oral Tablet

Other: Placebo oxytocin