NCT01148992终止1 期
Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adverse Event and Cardiovascular Response
研究概览
简要总结
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
详细描述
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
- •Be between 18 and 50 years of age, inclusive.
- •Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
- •Be able to verbalize understanding of the consent form and provide written informed consent.
- •Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:
- •diaphragm and condom by partner
- •intrauterine device (that does not contain progesterone) and condom by partner
- •sponge and condom by partner
- •complete abstinence from sexual intercourse
- •Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.
排除标准
- •Please contact site for more information
研究组 & 干预措施
Lofexidine
Active Comparator
干预措施: Lofexidine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event and Cardiovascular Response
时间窗: Daily, up to 9 days
Adverse Events will measured during follow-up at weeks 14-21
次要结局
- Visual Analog Scale (VAS)(Daily, up to 9 days)
- PK of Lofexidine(Daily, up to 9 days)
- Brief Substance Abuse Craving Scale (BSCA)(Daily, up to 9 days)
- Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)(Daily, up to 9 days)
研究者
研究点 (2)
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