Abuse Liability of Controlled-Release Oxycodone Formulations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
研究概览
简要总结
The objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. The investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.
详细描述
This is a single-center, single-dose, double-blind, placebo-controlled, randomized, crossover, abuse liability study conducted in healthy subjects who are non-dependent recreational opioid users. The study consists of 3 study days during which each subject will take one tablet of either 40mg OxyNEO®, 40mg Apo-Oxycodone CR®, or placebo. The participants will be assessed for both pharmacokinetic and pharmacodynamic outcomes.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects 18 to 50 years of age
- •Willing and capable to give written informed consent
- •Subjects must have used opioids recreationally to achieve a "high" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report
- •Females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test
- •Pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen
- •Willing to abstain from alcohol 12 hours before and during the study days
排除标准
- •Current or past Axis I psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence)
- •Current hepatic disease or renal failure
- •Pregnancy or lactation in women
- •Current medication that is known to interact with opioids
- •Known contraindications or hypersensitivity to opioids
- •Current opioid therapy
- •Chronic pain disorder requiring regular medication
研究组 & 干预措施
Apo-Oxycodone CR®
a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
干预措施: Apo-Oxycodone CR® (Drug)
Placebo
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
干预措施: Placebo (Drug)
OxyNEO®
a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
干预措施: OxyNEO® (Drug)
结局指标
主要结局
Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
时间窗: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration
时间窗: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
次要结局
- Pupil Diameter(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Cmax(Baseline to 6 hours post-administration)
- Profile of Mood States (POMS)(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Psychomotor Performance(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Any Drug Effects"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Good Effects"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Bad Effects"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Tmax(Baseline to 6 hours post drug administration)
- Visual Analogue Scale for "Sleepy"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Dizzy"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Sedation(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Euphoria(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Dysphoric Changes(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Psychotomimetic Changes(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Somatic Disturbances(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Take Drug Again"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Likert Scale for "Sedation"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Sensory Disturbances(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Feel Sick"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
- Visual Analogue Scale for "Nausea"(Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration)
研究者
Beth Sproule
Principal Investigator
Centre for Addiction and Mental Health