The Use of Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time
研究概览
简要总结
The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's disease. This proof-of-principle study is performed in healthy non-smokers and involves two single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4 mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24 mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the presence of this low dose of galantamine.
详细描述
Healthy non-smokers will be screened for study eligibility and receive training on three different attention tasks. Over four test session, participants will then perform these tasks after receiving (1) a placebo patch and a placebo capsule, (2) a nicotine patch (7 mg/24 hrs) and a placebo capsule, (3) a placebo patch and a galantamine capsule, and (4) a nicotine patch and a galantamine capsule. The four test session are performed on separate days and take approximately 7 hours each. During the first 5 hours, the participant may read or watch TV while nicotine and/or galantamine are being absorbed. During the last two hours, the participant will perform the attention tasks on a computer. The investigators hypothesize that performance-enhancing effects of nicotine, which were documented in previous research, will be larger in the presence than in the absence of galantamine. This proof-of-concept would have implications for the development of drugs for the treatment of conditions such as Alzheimer's disease or schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21 to 55 years.
- •No exposure to any nicotine-containing product in the last year.
- •Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime.
- •Normal or corrected to normal vision (at least 20/80).
- •Body weight 110-220 lbs.
排除标准
- •Pregnant or breast-feeding.
- •Drug or alcohol abuse or dependence currently or in the last 2 years.
- •DSM Axis I mood, anxiety or psychotic disorder.
- •Cardiovascular or cerebrovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval <120 ms or >200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min).
- •Uncontrolled hypertension (resting systolic BP above 140 or diastolic above 90 mm Hg).
- •Hypotension (resting systolic BP below 90 or diastolic below 60).
- •Significant kidney or liver impairment.
- •Moderate to severe asthma.
- •Obstructive pulmonary disease.
- •Type I or II diabetes.
- •Use of any centrally active medications; any peripherally acting cholinergic medications; cimetidine; ketoconazole; erythromycin; quinidine, or chronic nonsteroidal anti-inflammatory drugs.
- •History of or current neurological illnesses, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
- •Learning disability, mental retardation, or any other condition that impedes cognition.
- •Heart rate <55 bpm.
- •Current or history of gastric ulcer disease.
- •Any surgeries requiring full anesthesia scheduled within 2 weeks of any of the study test sessions.
- •Inability to perform the Rapid Visual Information Processing Task.
研究组 & 干预措施
Nicotine patch and placebo capsule
On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule.
干预措施: Nicotine patch & placebo capsule (Drug)
Placebo patch and placebo capsule
On the double-placebo test day, participants receive a placebo patch and a placebo capsule.
干预措施: Placebo patch & placebo capsule (Drug)
Placebo patch and galantamine capsule
On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.
干预措施: Placebo patch & galantamine capsule (Drug)
Nicotine patch and galantamine capsule
On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine.
干预措施: Nicotine patch and galantamine capsule (Drug)
结局指标
主要结局
Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time
时间窗: 45 min
The task requires detecting brief target stimuli presented at one of four locations in the four corner of the screen. On predictive trials, a central cue predicts the target location.
Rapid Visual Information Processing Task Hit Rate
时间窗: 30 min
The task requires following a stream of digits and detecting three consecutive odd or even numbers. The Hit Rate reflects the percentage of all target sequences that were detected.
Change Detection Task Accuracy
时间窗: 15 min
The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. Accuracy refers to the percentage of all trials in which a correct response was given. One participant's data were excluded from this task because of excessive no-response trials.
Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time
时间窗: 45 min
The task requires responding to brief target stimuli presented randomly in one of four locations in the four corners of the screen. On non-predictive trial, the cue does not provide any advance information about where the target will occur.
Rapid Visual Information Processing Task Reaction Time
时间窗: 30 min
The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.
Change Detection Task Reaction Time
时间窗: 15 min
The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. One participant's data were excluded from this task because of excessive no-response trials.
次要结局
- Profile of Mood Scale - Total Mood Disturbance(5 min)
研究者
Britta Hahn
Associate Professor
University of Maryland, Baltimore