Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
研究概览
简要总结
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recent cocaine use
排除标准
- •Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- •Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- •History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- •Females not currently using effective birth control
- •Contraindications to cocaine or phendimetrazine
研究组 & 干预措施
Placebo
Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Cocaine (Drug)
Placebo
Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Placebo (Drug)
Phendimetrazine
Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Phendimetrazine (Drug)
Phendimetrazine
Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Cocaine (Drug)
结局指标
主要结局
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
时间窗: After at least seven days of maintenance placebo or target phendimetrazine dose
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.
次要结局
未报告次要终点
研究者
William Stoops
Associate Professor
University of Kentucky