Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Systolic and Diastolic Blood Pressure
研究概览
简要总结
This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.
详细描述
Specific Aims:
Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.
Hypotheses related to Aim 1:
- Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.
- Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
- •At least one cocaine positive urine during screening.
- •Current regular consumption of caffeine.
- •Female subjects: a negative pregnancy test.
排除标准
- •Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
- •Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
- •Substance dependence other than cocaine within the last 3 months.
- •Positive breath alcohol.
- •Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
- •For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
- •Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
- •HIV positive.
- •I.Q. below 70.
研究组 & 干预措施
1 Caffeine 150 mg
Caffeine 150 mg
干预措施: Caffeine 150 MG (Drug)
2 Placebo
Placebo
干预措施: Placebo (Drug)
3 Amphetamine
Amphetamine
干预措施: Amphetamine (Drug)
4 Caffeine 300 mg
Caffeine 300 mg
干预措施: Caffeine 300 MG (Drug)
结局指标
主要结局
Systolic and Diastolic Blood Pressure
时间窗: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Sitting Blood Pressure
Addiction Research Center Inventory Subjective Rating of Drug Effects
时间窗: Immediately after dose
Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items. Includes the following subscales: Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)
Visual Analog Scale Subjective Rating of Drug Effects
时间窗: Immediately after dose
Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
Heart Rate
时间窗: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Sitting heart rate
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
时间窗: Immediately after dose
Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.
次要结局
- Probabalistic Feedback Selection Task(75 minutes after dose)
- Saliva Caffeine and Paraxanthine Levels(30 minutes prior to dose, 30/90/150 minutes post dose.)
研究者
Frederick Gerard Moeller
Professor - Division Chair, Addiction Psychiatry
Virginia Commonwealth University