NCT02141620已完成早期 1 期
Motivation for Cocaine and Non-Drug Reinforcers: Targeting Glutamate Homeostasis
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 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, safety and tolerability of n-acetylcysteine 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 n-acetylcysteine.
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
- •Current cocaine use
- •Current cigarette smoker
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 n-acetylcysteine
- •History of schizophrenia in first degree relative
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be maintained on oral placebo.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Subjects will be maintained on oral placebo.
干预措施: Cocaine (Drug)
n-Acetylcysteine
Experimental
Subjects will be maintained on oral n-acetylcysteine.
干预措施: Cocaine (Drug)
n-Acetylcysteine
Experimental
Subjects will be maintained on oral n-acetylcysteine.
干预措施: n-Acetylcysteine (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: One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.
次要结局
- Peak Score on Sedative Subscale of the Adjective Rating Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Score on Stimulant Subscale of the Adjective Rating Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Any Effect" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Bad Effects" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Euphoric" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Good Effects" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "High" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Like Drug" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Nauseous" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Willing to Pay For" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Performance Impaired" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Performance Improved" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Restless" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Rush" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Stimulated" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Ratings of "Willing to Take Again" on the Visual Analog Scale(Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Diastolic Blood Pressure(This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Systolic Blood Pressure(This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Heart Rate(This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
- Peak Temperature(This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.)
研究者
William Stoops
Associate Professor
University of Kentucky
研究点 (1)
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