Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Subject-rated abuse liability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
oxycodone (5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
oxycodone (5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
干预措施: Oxytocin nasal spray (Drug)
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
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
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
干预措施: Placebo oxytocin (Other)
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
干预措施: Oxytocin nasal spray (Drug)
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
干预措施: Placebo Oxycodone (Other)
placebo+placebo
Serves as the control
干预措施: Placebo Oxycodone (Other)
placebo+placebo
Serves as the control
干预措施: Placebo oxytocin (Other)
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
干预措施: Oxytocin nasal spray (Drug)
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
干预措施: OxyCODONE 2.5 mg Oral Tablet (Drug)
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
干预措施: Placebo oxytocin (Other)
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
干预措施: OxyCODONE 2.5 mg Oral Tablet (Drug)
结局指标
主要结局
Subject-rated abuse liability
时间窗: up to 6 weeks.
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.
次要结局
未报告次要终点