Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 12
- 主要终点
- The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
详细描述
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5
- •Is seeking treatment for cocaine use disorder
- •Is able to understand and provide written informed consent
- •Has used cocaine on at least 1 day in the last 30 days prior to screening
- •Has completed all psychological assessments and procedures during the screening period
- •If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control
- •Has a total body weight greater than 110 pounds and body mass index greater than 20
排除标准
- •Contact site for more information
研究组 & 干预措施
Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
干预措施: Lorcaserin (Drug)
Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population
时间窗: Treatment weeks 11 - 13
Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.
次要结局
- The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence(Treatment weeks 11-13)