Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be volunteers who are not seeking treatment for drug addiction.
- •Be between 18 and 50 years-of-age.
- •Meet Diagnostic and Statistical Manual (DSM-IV) - Text Revision (TR) criteria for current cocaine abuse as assessed using the MINI neuropsychiatric interview (version 6.0).
- •Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
- •Have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.
- •Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
- •Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
- •Females must have a negative serum pregnancy test at screening and negative urine pregnancy test at intake prior to receiving the first dose of investigational drug. They must also be postmenopausal, have had a hysterectomy, been sterilized, have a partner with a vasectomy, or agree to use one of the following methods of birth control starting at least 14 days prior to clinic intake:
- •diaphragm and condom by partner
- •condom and spermicide by partner
- •intrauterine device and condom by partner
- •sponge and condom by partner
- •complete abstinence from sexual intercourse
- •oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive
- •Be able to comply with protocol requirements, rules and regulations of the study site and be likely to complete all the study treatments.
排除标准
- •Please contact site directly for more information
研究组 & 干预措施
Placebo
Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
干预措施: Placebo (Drug)
Lorcaserin
Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
干预措施: Lorcaserin (Drug)
Lorcaserin
Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10
干预措施: Cocaine Infusion (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: From intake (day -3) through follow-up (day 26)
Number of Participants with Cardiovascular Responses
时间窗: From screening (day -28 through day -4) through follow-up (day 26)
次要结局
- Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma(Day 4, 6, 8 through 12)