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临床试验/NCT01037153
NCT01037153已完成不适用

Effects of Nicotine on Brain Activity as Measured by fMRI

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2002年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
1

研究概览

简要总结

Background:

  • Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments.

Objectives:

  • To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers.

Eligibility:

  • Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age.

Design:

  • The study involves five separate research experiments. Most participants will be involved in only one experiment.
  • The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study.
  • Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine.
  • Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours.
  • Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette).
  • Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session.
  • Experiment 5: Participants will have three fMRI sessions that will involve looking at different kinds of pictures related to or not related to smoking after receiving a single injection of nicotine.
  • Participants will also provide blood samples for further study....

详细描述

Objective:

The overall goal of this protocol is to employ fMRI to define nicotine's neural pharmacokinetic and pharmacodynamic properties and neurochemical sites and mechanisms of action in experienced smokers and to correlate these with monoamine and nicotinic receptor genotypes as well as to determine behavioral correlates of nicotine during various conditions of delivery and regress behavioral correlates of nicotine administration against neuroanatomical sites of activation across subjects.

Study Population:

The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers. Subjects must smoke at least 20 cigarettes per day for at least 1 year. They cannot be dependent on any drug or alcohol except nicotine and caffeine. In addition, they must be appropriate candidates for fMRI scanning.

Design:

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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