A Randomized, Double-blind, Placebo-controlled, Dose of RBP-8000 Following IV Cocaine to Evaluate the Pharmacokinetics Parameters of RBP-8000 and Cocaine and to Assess the Effects of Drug on Cocaine-induced Physiologic and Behavioral Effects in Cocaine Abusing Subjects

Indivior Inc.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2013年4月最近更新: 2016年9月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Indivior Inc.
入组人数: 40
试验地点: 1
主要终点: Maximum plasma concentration (Cmax) of Cocaine, (-)Ecgonine methyl ester and RBP-8000

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.

详细描述

There will be a 28-day screening period with eligible subjects remaining resident in the clinic from the evening before Day -1 up and until the morning of Day 9. On the morning of Day 1, a 50 mg intravenous (IV) infusion of cocaine will be administered over 10 minutes to all subjects. If none of the stopping criteria were met and no intervening safety concerns, subjects will be randomized to one of the treatment sequences on Day 3. On dosing days, Day 3 and Day 6, subjects will have fasted at least 8 hours before dosing of cocaine and either RBP-8000 200 mg, RBP-8000 100 mg or matching placebo.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 21 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male and female volunteers aged 21-50 years, inclusive
•Body mass index (BMI)18-32 kg/m^2 and weight of at least 50 kg
•Not currently seeking treatment for substance abuse or substance dependence
•Subject is healthy, in the opinion of the Principal Investigator other than cocaine abuse; as determined by the absence of clinically significant medical/psychiatric history or findings, particularly cardiovascular or central nervous system (CNS) disease, physical examination, normal renal function, ECG findings, vital signs, and laboratory results at screening
•Males agree to refrain from sperm donations for the entire duration of the study, and for at least 90 days after the last dose of study drug
•Has experience using cocaine by the smoked or IV route at least 6 times in past 12 months and a positive urine drug screen for cocaine prior to study intake (Day -2). Has experience using cocaine by the smoked or IV route in the past 3 months and a positive urine drug screen for cocaine during screening prior to study check-in at the clinic
•Be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, prior to the initiation of any protocol-specific procedures
•Meet DSM-IV-TR criteria for current cocaine abuse
•Be able to comply with protocol requirements, rules, and regulations of the study site, and be likely to complete all the study procedures in the opinion of the Principal Investigator

排除标准

•Current or past history of seizure disorder, including alcohol- and/or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder. Have any previous clinically significant reaction to cocaine, including loss of consciousness or seizure
•Current alcohol dependence or current drug dependence according to DSM-IV-TR criteria (excluding nicotine and caffeine)
•Clinically significant history of cardiac disease, including cardiovascular and conduction abnormalities or ECG evidence of cardiac abnormalities
•QTcF greater than or equal to 450 for male subjects and 470 for female subjects as measured through a 12-lead ECG
•History of liver disease or current elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 3x the upper limit of normal
•Be on probation or parole, and/or have current or pending legal charges with the potential for incarceration that could interfere with the study scheduling
•Women with a positive pregnancy test at screening; or women who are pregnant or lactating or who are seeking to become pregnant
•Women of childbearing potential (who are sexually active with a male) who fail to use medically acceptable contraception methods (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, a double barrier method, or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral ovariectomy (oophorectomy). Females that are post-menopausal will be confirmed as such by the follicle stimulating hormone (FSH) test at initial screening
•Males who do not agree to use barrier contraception and spermicide when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication
•History of clinically significant severe allergic or anaphylactic reactions