Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Cocaine Positive Urines
研究概览
简要总结
This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recent cocaine use
- •Seeking treatment for 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 or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation
- •Females not currently using effective birth control
- •Contraindications to cocaine, methylphenidate or duloxetine
- •Currently using opioids for pain or who are currently maintained on methadone or buprenorphine for opioid use disorder will be excluded from participation
- •Body weight less than 50 kg
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.
干预措施: Methylphenidate (Drug)
Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.
干预措施: Placebo (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
干预措施: Methylphenidate (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
干预措施: Placebo (Drug)
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Number of Cocaine Positive Urines
时间窗: Six weeks
Cocaine use will be assessed using qualitative urine drug screens over a six week period.
次要结局
- Self-Reported Cocaine Use(Six weeks)
- Blood Pressure(Six weeks)
- Heart Rate(Six weeks)
- Side effects(Six weeks)
研究者
Craig Rush
Professor
University of Kentucky