Infusion Laboratory: Protocol 1 - Selegeline
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Population incidence of symptoms of depression, possible organic brain syndrome deficits
研究概览
简要总结
The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.
详细描述
To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 31 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •M/F, ages 21-
- •Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.
排除标准
- •Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
结局指标
主要结局
Population incidence of symptoms of depression, possible organic brain syndrome deficits
Frequency and intensity of drug use and sexual behaviors at risk for HIV
Evidence of change in neurophysiology and brain activity
Characterization of study population
Evidence of change in subjective responses to cocaine challenge
Degree of drug craving
History, incidence and amount of drug use
Clinical physiological response to cocaine challenge - especially adverse effects measures
Type and severity of stimulant withdrawal symptoms
Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)
次要结局
未报告次要终点