NCT01136642已完成1 期
Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Performance (accuracy response time) on a test of selective attention.
研究概览
简要总结
Background:
- Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research.
- The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms.
Objectives:
- To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Eligibility:
- Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age.
Design:
- This study will involve one training session and four experimental sessions.
- During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects.
- For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different sessions, and will not be told which dose they will receive at any given point.
详细描述
Objective:
The objective is to investigate the dose-response effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Study population:
Male and nonpregnant-female smokers 18 to 55 years of age.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
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
- •INCLUSION CRITERIA:
- •18-55 year old male and female cigarette smokers
- •smoke a minimum of 10 cigarettes per day for at least 1 year
- •-Drug Use Survey
- •estimated IQ score greater than or equal to 85
- •-Weschsler Abbreviated Scale of Intelligence (WASI; raw vocabulary cutoff 49)
- •urine cotinine concentration greater than or equal 100 ng/ml
- •NicAlert reading greater than or equal to 3
排除标准
- •definite plan to quit smoking in next 30 days
- •consumption of more than 15 alcoholic drinks per week during the past month
- •use of any illicit drugs more than twice per week during the past month
- •-Drug Use Survey (items 2-4)
- •pregnant or nursing
- •-Urine pregnancy test
- •HIV positive
- •-Oral HIV test
- •untreated cardiovascular or pulmonary disease
- •use of nicotine replacement products, bupropion or varenicline, in the past 3 months if specifically used to stop smoking
- •Past history of schizophrenia or bipolar disorder.
- •Current Major Depression Disorder, Diagnosis or treatment for Major Depressive Disorder in past 12 months. (H&P)
- •Evidence of current ADHD by current diagnosis or medication or score on Adult Symptom Rating Scale; (> 16 on pt A or B must be evaluated by a counselor)
- •SCL-90 > 65 (must be evaluated by a counselor)
- •Beck Depression Inventory-II score greater than or equal to 14 (must be evaluated by a counselor)
- •vital signs (must be outside these parameters on more than two occasions separated by at least one day):
- •systolic blood pressure: minimum 95, maximum 160 mm Hg
- •diastolic blood pressure: minimum 40, maximum 95 mm Hg
- •pulse: minimum 50, maximum 105 bpm
- •respirations: minimum 8, maximum 24 breaths per minute
- •nasal passages: no pathology that would preclude administration of nasal spray
- •under the influence of a drug or alcohol at experimental sessions
结局指标
主要结局
Performance (accuracy response time) on a test of selective attention.
次要结局
- Vital signs, ratings of mood and drug effect.
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit AttemptSmoking, CigaretteCravingNicotineAddictionNCT03576768Medical University of South Carolina25
已完成
不适用
QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit AttemptNicotine DependenceCigarette SmokingSmoking CessationCravingAddiction NicotineSmokingAddictionNCT04159571Wake Forest University Health Sciences40
招募中
2 期
Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSDTobacco Use DisorderNCT05723588VA Office of Research and Development50
撤回
不适用
Cognitive and Emotional Skills to Aid Smoking CessationCigarette SmokingNCT03148652Boston University Charles River Campus
已完成
不适用
An EPIC Based BPA to Enhance Quit Line Referral and UseSmoking CessationNCT03229356Johns Hopkins University22
