NCT01359930已完成1 期
Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced 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
- 16
- 试验地点
- 1
- 主要终点
- Cardiovascular System Effects
研究概览
简要总结
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are MA experienced but not dependent, males or females aged 21-to-50 years.
- •Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use.
- •Have a body mass index (BMI) between 18 and
- •Are willing and able to give written consent.
- •Are not currently a subject (including still in the follow-up period) of another drug research study.
- •Have no medical contraindications determined by the following: an adequate medical history, a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- •Have a negative drug test for barbiturates, benzodiazepines, opiates, cocaine, amphetamines and ethanol at the time of hospital admission (Day 0).
- •Are females who have a negative pregnancy test at hospital admission.
- •Are of either non-childbearing (tubal ligation or total hysterectomy) or of childbearing potential using one or more of the following barrier methods of contraception: male or female condoms (with/without spermicide), diaphragm (with spermicide) and/or copper containing intrauterine device (with/without spermicide). No other contraceptives are acceptable.
排除标准
- •Please contact site for more information
研究组 & 干预措施
Naltrexone and Bupropion SR
Active Comparator
干预措施: Naltrexone and Bupropion SR (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Cardiovascular System Effects
时间窗: daily during the 10 day treatment period
Heart rate, blood pressure, ECGs,and monitoring adverse events
Number of subjects with adverse events
时间窗: Day 0 through Day 10
次要结局
- Cognitive Assessments as reported by the subject(Dailly during the 10 day treatment period)
- Assessment of Vital Signs and Clinical Chemistries(Daily during the 10 day treatment period)
- Plasma concentrations obtained at specific timepoints(daily during the 10 day treatment period)
研究者
研究点 (1)
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