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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Subject-rated abuse liability [Срок оценки: up to 6 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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