A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.
研究概览
简要总结
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non treatment seeking cocaine dependent
- •English speaking
- •meet DSM IV TR criteria for cocaine dependence
- •pulse 50-90bpm
- •systolic BP 85-140 mmHg
- •diastolic BP 45-90 mmHg
- •essentially normal liver and kidney function blood tests
- •ECG normal
- •sign informed consent
- •negative urine pregnancy test at screening and admission
排除标准
- •history or evidence of seizure disorder or brain injury
- •previous medically adverse reaction to cocaine, including loss of consciousness, chest pain or epileptic seizure
- •neurological disorders, organic brain disease, dementia
- •psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major depression
- •history of suicide attempts within past 3 months or suicidal ideation/plan
- •history of clinically significant heart disease or hypertension
- •family history in 1st degree relatives of early cardiovascular morbidity or mortality
- •untreated or unstable medical conditions
- •positive HIV test
- •pregnant or nursing
- •have asthma or are currently using alpha, beta agonists or theophylline or other sympathomimetics
- •test positive for other drugs of abuse with the exception of cocaine, cocaine metabolites or marijuana
- •any other illness, condition or use of psychotropic medications which preclude safe/successful completion of the study
- •currently on parole
研究组 & 干预措施
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
干预措施: Cocaine 40mg (Drug)
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
干预措施: Saline (Drug)
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
干预措施: SYN117 Placebo (Drug)
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
干预措施: Cocaine 10mg (Drug)
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
干预措施: Cocaine 20mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: SYN117 80 mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: SYN117 160 mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: Cocaine 10mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: Cocaine 20mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: Cocaine 40mg (Drug)
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
干预措施: Saline (Drug)
结局指标
主要结局
Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.
时间窗: inpatient 14 days with 2 week outpatient follow-up
次要结局
- Determine tolerability by measuring adverse events(inpatient 14 days, 2 weeks post followup visit)
- Determine subjective effects produced by self administration of cocaine or placebo(Days 4, 8, 12 and 13)
- Determine the effect of SYN117 of the pharmacokinetics of IV cocaine(Days 3 and 11)
- Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine(Days 4, 8 and 12)