NCT01887366已完成2 期
A 12-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/Week or 300 mg/Week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 19
- 主要终点
- Urine test for cocaine
研究概览
简要总结
The primary objective of this study is to assess the efficacy and safety of TV-1380 [Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)] in facilitating abstinence in cocaine-dependent subjects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
- •Male or female aged 18-60 years (inclusive).
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- •Other criteria apply; please contact the site for more information.
排除标准
- •Meet criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.
- •Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.
- •Have one or more severe psychiatric disorders as determined by the Mini International Neuropsychiatric Interview (MINI) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening.
- •Have one or more major neurologic disorders such as dementia or organic brain disease.
- •Have other serious medical illnesses (including but not limited to uncontrolled hypertension, significant heart disease, respiratory disease including asthma, hepatic disease, renal disease, AIDS) or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.
- •Other criteria apply; please contact the site for more information.
研究组 & 干预措施
TV-1380 150 mg
Experimental
干预措施: TV-1380 150 mg (Drug)
TV-1380 300 mg
Experimental
干预措施: TV-1380 300 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Urine test for cocaine
时间窗: Treatment Phase weeks 10 - 12
次要结局
- Percent of urine samples that are considered negative for cocaine metabolites.(Treatment Phase Weeks 5 -12)
- Summary of participants with adverse events(From signing of the informed consent form to the end of the follow-up period (Week 16))
研究者
研究点 (19)
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