A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Drug Liking at .5 Hours
研究概览
简要总结
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
详细描述
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Matching white tablets
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
- •Subject is male or female between 18 and 55 years old.
- •Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m
- •Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will provide written informed consent.
- •Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).
排除标准
- •History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
- •History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
- •Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.
研究组 & 干预措施
40/0mg taken first
8x oxycodone/niacin 5/0mg tablets
干预措施: 40/0mg taken first (Drug)
80/0mg taken first
8x oxycodone/niacin 10/0mg tablets
干预措施: 80/0mg taken first (Drug)
40/240mg taken first
8x oxycodone/niacin 5/30mg tablets
干预措施: 40/240mg taken first (Drug)
80/480mg taken first
8x oxycodone/niacin 10/60mg tablets
干预措施: 80/480mg taken first (Drug)
0/0mg taken first
Placebo
干预措施: 0/0mg taken first (Drug)
结局指标
主要结局
Drug Liking at .5 Hours
时间窗: Measure collected at 0.5 hours post-dose
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
次要结局
未报告次要终点