A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of EMB 001 in Subjects With Moderate-to-Severe Cocaine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Continuous Abstinence from Cocaine Use
研究概览
简要总结
EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only).
This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).
详细描述
This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, study to compare the safety and efficacy of EMB-001 with a placebo control in approximately 80 subjects with moderate-to-severe CUD. Subjects will receive investigational medicinal product (IMP) during a 12-week, double-blind Treatment Period (Week 2 through Week 13) and a 1-week, double-blind Taper Period (Week 14).
After undergoing study procedures during the Screening and Baseline Periods, subjects who meet inclusion and exclusion criteria will then be randomized in a 1:1 ratio (n=40/arm) to one of the following for the Treatment Period (weeks 2 - 13) on Study Day 8:
- EMB-001 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam (Active Group)
- Placebo BID, (Placebo Group)
During the Taper Period (week 14), subjects in the Active Group will receive EMB-001 240/8 mg BID; and the Placebo Group will continue to receive placebo. Both groups will change from taking three capsules BID (twice daily) to one capsule BID (twice daily).
There will be a follow-up visit for safety assessments at Week 18.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to any study procedures
- •18 to 65 years of age
- •DSM-5 diagnosis of moderate-to-severe CUD
- •Seeking treatment for CUD. Subjects with past rehabilitation attempts are eligible if the most recent rehabilitation attempt ended at least 30 days prior to Screening
- •Female subjects must be of non-childbearing potential
- •Male subjects must agree to use accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study drug
排除标准
- •Any significant current medical conditions
- •Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug
- •Heightened likelihood of having adrenal insufficiency in the investigator's or designees' opinion
- •Current court-mandated treatment requirement for a substance-use disorder
- •Current DSM-5 moderate-to-severe substance use disorder, other than CUD, tobacco or caffeine
- •Current DSM-5 opioid or benzodiazepine use disorder of any severity
研究组 & 干预措施
EMB-001 Active
EMB-001 Combination product of 720 mg metyrapone/24 mg oxazepam mg by mouth twice per day for 12 weeks followed by a 1 week taper
干预措施: EMB-001 (Drug)
EMB-001 Placebo
EMB-001 Placebo by mouth twice per day for 12 weeks followed by a 1 week taper
干预措施: EMB-001 Placebo (Drug)
结局指标
主要结局
Continuous Abstinence from Cocaine Use
时间窗: Week 11 to Week 13
The Primary Endpoint is the Proportion of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment using the Timeline Follow Back; days of abstinence, confirmed by Urine benzoylecgonine (BE)
次要结局
- Urine confirmation of cocaine use(Week 2 to Week 13)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(13 weeks)
- Reduction in cocaine-use days(Week 2 to Week 13)
- Reduction in total Cocaine Craving Questionnaire-Brief score(Week 2 to Week 13)