Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Craig Rush
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Reinforcing Effects of Cocaine Following Placebo Maintenance.
研究概览
简要总结
This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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, methylphenidate or duloxetine
研究组 & 干预措施
Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. 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. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Placebo oral capsule (Drug)
Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Methylphenidate (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Cocaine (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Placebo oral capsule (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Reinforcing Effects of Cocaine Following Placebo Maintenance.
时间窗: Following at least 4 days of maintenance on placebo during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Duloxetine Maintenance.
时间窗: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.
时间窗: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.
时间窗: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
次要结局
- Delay Discounting Task(Nine times over approximately four weeks inpatient admission.)
- Attentional Bias(Nine times over approximately four weeks inpatient admission.)
- Inhibitory Control(Nine times over approximately four weeks inpatient admission.)
- Adjective Rating Scale-Sedative(Nine times over approximately four weeks inpatient admission.)
- Adjective Rating Scale-Stimulant(Nine times over approximately four weeks inpatient admission.)
- Drug Effect Questionnaire(Nine times over approximately four weeks inpatient admission.)
- Heart rate(Daily over approximately four week inpatient admissions.)
- Blood pressure(Daily over approximately four week inpatient admissions.)
- Temperature(Daily over approximately four week inpatient admissions.)
- Side effects(Daily over approximately four week inpatient admissions.)