Modafinil in a Human Laboratory Model of Cocaine Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cocaine Self-administration
研究概览
简要总结
Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokes cocaine
- •Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
- •Able to give informed consent, and comply with study procedures.
- •Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -
排除标准
- •Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
- •Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
- •Request for drug treatment
- •Judged to be noncompliant with study protocol.
- •Current use of any psychotropic medication.
- •Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
- •History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- •Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
- •Current parole or probation Self-report during interview -
研究组 & 干预措施
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 0 mg (Drug)
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 12 mg (Drug)
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Modafinil 0 mg (Drug)
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 0 mg (Drug)
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 12 mg (Drug)
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 25 mg (Drug)
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 50 mg (Drug)
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Modafinil 200 mg (Drug)
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 25 mg (Drug)
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 50 mg (Drug)
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Modafinil 400 mg (Drug)
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 0 mg (Drug)
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 12 mg (Drug)
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 25 mg (Drug)
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
干预措施: Cocaine 50 mg (Drug)
结局指标
主要结局
Cocaine Self-administration
时间窗: 48 days
The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.
次要结局
- Heart Rate(48 days)
- Drug Quality Cluster(48 days)