New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sharon Walsh
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Abuse Liability Proxy
研究概览
简要总结
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.
详细描述
Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recreational user of opioids
- •Ages 18-55 years old
- •Able to provide informed consent
排除标准
- •Ongoing medical or psychiatric condition that would be contraindicated for participation
- •Past 30 day use of and P4503A4 inhibitor
研究组 & 干预措施
Placebo aprepitant/ oxycodone 30 IN 0 PO
Placebo aprepitant/ oxycodone 30 IN 0 PO
干预措施: Aprepitant 0mg (Drug)
Placebo aprepitant/0 mg oxycodone IN PO
Placebo aprepitant/Placebo oxycodone IN/PO
干预措施: Aprepitant 0mg (Drug)
Placebo aprepitant/0 mg oxycodone IN PO
Placebo aprepitant/Placebo oxycodone IN/PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Placebo aprepitant/0 mg oxycodone IN PO
Placebo aprepitant/Placebo oxycodone IN/PO
干预措施: Oxycodone 0mg, IN (Drug)
Placebo aprepitant/ oxycodone 15 IN 0 PO
Placebo aprepitant/ oxycodone 15 IN 0 PO
干预措施: Aprepitant 0mg (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
干预措施: Aprepitant 40mg (Drug)
Placebo aprepitant/ oxycodone 15 IN 0 PO
Placebo aprepitant/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Placebo aprepitant/ oxycodone 15 IN 0 PO
Placebo aprepitant/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 15mg, IN (Drug)
Placebo aprepitant/ oxycodone 30 IN 0 PO
Placebo aprepitant/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Placebo aprepitant/ oxycodone 30 IN 0 PO
Placebo aprepitant/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 30mg, IN (Drug)
Placebo aprepitant/ oxycodone 0 IN 20 PO
Placebo aprepitant/ oxycodone 0 IN 20 PO
干预措施: Aprepitant 0mg (Drug)
Placebo aprepitant/ oxycodone 0 IN 20 PO
Placebo aprepitant/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 20mg, p.o. (Drug)
Placebo aprepitant/ oxycodone 0 IN 20 PO
Placebo aprepitant/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 0mg, IN (Drug)
Placebo aprepitant/ oxycodone 0 IN 40 PO
Placebo aprepitant/ oxycodone 0 IN 40 PO
干预措施: Aprepitant 0mg (Drug)
Placebo aprepitant/ oxycodone 0 IN 40 PO
Placebo aprepitant/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 40mg, p.o. (Drug)
Placebo aprepitant/ oxycodone 0 IN 40 PO
Placebo aprepitant/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
干预措施: Aprepitant 40mg (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 20mg, p.o. (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
干预措施: Aprepitant 40mg (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 40mg, p.o. (Drug)
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
干预措施: Aprepitant 40mg (Drug)
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 15mg, IN (Drug)
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
干预措施: Aprepitant 40mg (Drug)
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 30mg, IN (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
干预措施: Aprepitant 200mg (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
干预措施: Aprepitant 200mg (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 20mg, p.o. (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
干预措施: Aprepitant 200mg (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 40mg, p.o. (Drug)
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
干预措施: Oxycodone 0mg, IN (Drug)
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
干预措施: Aprepitant 200mg (Drug)
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
干预措施: Oxycodone 15mg, IN (Drug)
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
干预措施: Aprepitant 200mg (Drug)
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 0mg, p.o. (Drug)
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
干预措施: Oxycodone 30mg, IN (Drug)
结局指标
主要结局
Abuse Liability Proxy
时间窗: 42 days
Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.
次要结局
- Respiration Depression(42 days)
研究者
Sharon Walsh
Director Center on Drug and Alcohol Research
University of Kentucky