NCT00733720已完成1 期
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Opioid Effects of study drug
研究概览
简要总结
The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.
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
- 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
- •Provide written informed consent
- •Be male/female between the ages of 18-55
- •Be in good physical and mental health as determined by interview and physical exam
- •Have a body mass index between 18 and 30, inclusive
- •Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
- •Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
- •Be able to comply with protocol requirements
- •If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo
排除标准
- •please contact site for more information
研究组 & 干预措施
1
Active Comparator
Each subject will receive all 3 doses of suboxone and placebo
干预措施: Suboxone (Drug)
结局指标
主要结局
Opioid Effects of study drug
时间窗: daily
次要结局
- Adverse Events(Daily)
研究者
研究点 (1)
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