A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Changes in relapse to cocaine use in CLAV group vs PBO group
研究概览
简要总结
A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)
详细描述
This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- •Be male or female adult volunteers ages 18-70 inclusive.
- •Have a Diagnostic and Statistical Manual (DSM-V) diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.
- •Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.
排除标准
- •Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.
- •Allergy to clavulanic acid, penicillin, or any beta-lactam drug.
- •Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- •Severe physical or medical illnesses such as AIDS or active hepatitis.
- •If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)
研究组 & 干预措施
Clavulanic Acid
Participants may receive 500 mg of CLAV at baseline. Subjects who are using cocaine once per week or more and who can tolerate 500 mg/day for 4 weeks, will have a dose escalation to 750 mg/day. If tolerated, 750mg/day will be maintained for 8 weeks, otherwise the dose will decrease to 500mg/day.
干预措施: Clavulanic Acid Only Product (Drug)
Placebo
Participants may receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in relapse to cocaine use in CLAV group vs PBO group
时间窗: Last 3 weeks of 12 week study
Cocaine-free weeks are measured by self-report using Timeline Follow Back (TLFB) and confirmed by urine drug screen.
次要结局
- Changes in weekly abstinence in the CLAV group vs. PBO group(Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up)
- Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group(TLFB and UDS will be administered 1-3 times per week and at follow-up)
- Changes in subject health and function, quality-of-life, will be greater in the CLAV group vs. PBO group(Baseline, week 4, week 8, week 12)
- Clavulanic acid 500-750 mg/day for 12 weeks will be safe and reasonably well tolerated(1-3 times per week and at follow-up)
- Cocaine craving will be decreased more by CLAV vs. PBO(1-3 times per week and at follow-up)