An Exploratory, Single-Dose, Double-Blind, Randomized, Placebo-Controlled Crossover Study to Evaluate The Subjective and Objective Effects of Extended-Release Oxymorphone Compared to Controlled-Release Oxycodone in Healthy Non-Dependent Recreational Opioid Users
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 主要终点
- High VAS - Emax (mm)
研究概览
简要总结
The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).
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
- Quadruple (Participant, Care Provider, 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 opioid use.
- •At least 3 lifetime occasions of recreational use of an oral intact modified-release opioid product.
- •BMI within range of 19.0 to 29.9 kg/m2, inclusive, minimum weight of 50.0 kg at screening and Day 0 of treatment period 1
排除标准
- •Self-reported history of drug or alcohol dependence in the past 2 years or presence of drug or alcohol dependence in the past 12 months as defined by the DSM-IV, including subjects who have ever been in a drug rehabilitation program.
- •Unwillingness or inability to abstain from recreational drug use as required for the study.
- •History of acute asthma or other obstructive airway disease or any condition that may increase the risk for respiratory depression, judged as clinically significant by the investigator or designee.
- •History of neurologic conditions such as convulsive disorders or severe head injury, judged as clinically significant by the investigator or qualified designee.
- •History of Addison's disease, hypothyroidism, pancreatitis, prostatic hypertrophy, or urethral stricture.
- •Use of non-prescription or prescription medications or natural health products within 7 days prior to first drug administration in the qualification phase and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject.
- •Uses of Monoamine oxidize inhibitors (MAOIs) within 14 days of first drug administration in the qualification phase and throughout the study.
- •Current consumption of greater than 20 cigarettes (or 2 cigars) per day or inability to abstain from smoking (or use of any nicotine-containing sub stance) for at least 14 hours.
研究组 & 干预措施
Oxycodone CR 60mg
60mg
干预措施: Oxycodone CR (Drug)
Oxymorphone ER 15 mg
15mg
干预措施: Oxymorphone ER (Drug)
Oxymorphone ER 15 mg
15mg
干预措施: Hydromorphone (Drug)
Oxycodone CR 30 mg
30mg
干预措施: Oxycodone CR (Drug)
Oxycodone CR 30 mg
30mg
干预措施: Hydromorphone (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Hydromorphone (Drug)
Oxymorphone ER 30mg
30mg
干预措施: Oxymorphone ER (Drug)
Oxymorphone ER 30mg
30mg
干预措施: Hydromorphone (Drug)
Oxycodone CR 60mg
60mg
干预措施: Hydromorphone (Drug)
结局指标
主要结局
High VAS - Emax (mm)
时间窗: High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.
The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar ("I am feeling high"). The ends of the line were marked with the descriptive anchors ("Definitely not" and "Definitely so"). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line.
次要结局
未报告次要终点