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Neuroimaging of Smokers With and Without Attention Deficit Hyperactivity Disorder (ADHD)

2018年11月7日 更新者:Duke University

Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence

The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.

Study Hypotheses:

  1. compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced decrements in response inhibition performance and reward and greater concomitant disruptions of brain activity
  2. administration of MPH to abstinent smokers will ameliorate response inhibition performance and reward deficits and task-related brain activation and this effect will be greater among ADHD smokers
  3. genetic markers of dopamine neurotransmission will moderate abstinence- and MPH - induced changes in task-related brain activation across tasks.

研究概览

地位

完全的

条件

详细说明

Individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) smoke more than the general population, initiate use at a younger age, and report more difficulty trying to quit. The overarching goal of the present application is to use neuroimaging, neuropharmacological and molecular genetic techniques to study the neurobiological basis of abstinence-induced deficits in response inhibition in ADHD and non-ADHD smokers. Twenty smokers with ADHD and 20 smokers without ADHD will undergo imaging during a Go/No-Go task under the following conditions: 1) smoking as usual, 2) 24 hr smoking abstinence, and 3) 24 hr smoking abstinence + methylphenidate (MPH). We hypothesize that compared to smoking as usual, 24 hr smoking abstinence will result in decrements in response inhibition and disruption of task-related brain activation. These effects will be greater in ADHD as compared to non-ADHD smokers. We further hypothesize that MPH administration during abstinence will restore performance and brain indices of response inhibition and that the magnitude of the effect of MPH will be greater among smokers with ADHD. In addition to the above aims, we will preliminarily evaluate the moderating effects of the dopamine receptor D4 7-repeat allele on task-related brain activation following smoking abstinence and MPH administration.

During the study, 101 subjects signed consents and 38 subjects completed the study.

研究类型

观察性的

注册 (实际的)

101

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27705
        • Duke Child and Family Study Center//Duke Health Behavior Neuroscience Research Program

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

120 voluntary participants to yield 40 Adult Regular Smokers, including 20 diagnosed with ADHD and 20 comparison controls.

描述

Inclusion Criteria:

  1. generally healthy, between the ages of 18-50yrs,
  2. smoking at least 10 cigarettes/day of a brand delivering ≥0.5 mg nicotine according to the standard Federal Trade Commission (FTC) method,
  3. an expired Carbon Monoxide concentration of at least 10ppm (to confirm inhalation) or a positive urine cotinine test (Nicalert ™) of 3 or greater,
  4. no interest in quitting smoking as measured by self-report,
  5. right-handed as measured by a three item scale used in our laboratory.

Exclusion Criteria:

  1. unable to attend all required experimental sessions,
  2. have significant health problems (e.g., chronic hypertension, emphysema, seizure disorders, history of significant heart problems),
  3. use of psychoactive medications with the exception of ADHD pharmacotherapies among ADHD diagnosed participants (see washout procedures below)
  4. use of smokeless tobacco
  5. current or past year alcohol or drug abuse,
  6. use of illegal drugs as measured by urine drug screen or self report
  7. current use of nicotine replacement therapy or other smoking cessation treatment,
  8. presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD),
  9. if they are female and pregnant or plan on becoming pregnant.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
ADHD and non-ADHD Smokers
Those that are defined as regular smokers (10 cigarettes/day or Carbon Monoxide reading of 10 ppm). The group will then be split into those diagnosed with ADHD/ADD and controls for comparison.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.
大体时间:July 2009 through December 2013
Smokers will undergo three functional Magnetic Resonance Image scanning sessions while performing a task that measures response inhibition (Go/Go/No-Go task) Scanning will take place in the following conditions: smoking as usual + placebo pill, 24 hr smoking abstinence + placebo pill and 24 hr abstinence + methylphenidate (MPH). Methylphenidate is a dopamine reuptake inhibitor and its administration will allow us to evaluate the role of dopamine neurotransmission on response inhibition in the context of smoking abstinence.
July 2009 through December 2013

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Francis J McClernon, Ph.D.、Duke Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年7月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2010年5月12日

首先提交符合 QC 标准的

2010年5月13日

首次发布 (估计)

2010年5月14日

研究记录更新

最后更新发布 (实际的)

2018年11月8日

上次提交的符合 QC 标准的更新

2018年11月7日

最后验证

2014年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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