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临床试验/NCT01048957
NCT01048957已完成不适用

The Neural Basis of Cue-Elicited Cigarette Craving and Its Control

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年1月9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
79
试验地点
2
主要终点
To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.

研究概览

简要总结

Background:

  • One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a drug-related cue (such as an image of someone using the drug) begins to feel a craving for the drug. Researchers are interested in studying how cue-elicited craving affects brain activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data.

Objectives:

  • To determine which parts of the brain are associated with or involved in controlling cue-related craving in smokers.

Eligibility:

  • Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes per day) and agree to try to abstain from smoking for 1 week during the experiment.

Design:

  • Participants will visit a clinical center for up to four scanning sessions, and will be asked to perform two or three outpatient tasks at home over the course of the study.
  • Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning session and EEG in which participants respond to pictures.
  • Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12 additional hours without cigarette use).
  • Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing craving.
  • Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days, responding to questions as directed by the researchers.
  • Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants will be instructed on methods to attempt to control cravings.
  • Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first 7 days, participants will be asked to attempt to abstain from nicotine; participants may smoke normally on the second 7 days.
  • Participants will be contacted 1, 3, 6, and 12 months after the end of the study for follow-up questions on current smoking habits.

详细描述

Objective

Drug craving is a motivational state associated with a conscious desire to consume a drug (Fredrickson et al., 1995; Drummond, 2001). When drug abusers see drug-related cues, cue-elicited drug craving is induced (Drummond, 2001). The main goal of this investigation is to ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.

Study population: The experimental population for this investigation is nicotine-dependent adults aged 18-50 years old.

Design: Participants will see the smoking-related cue or neutral cue and complete cognitive tasks (e.g. to report or regulate their craving, etc). At same time, we will employ functional magnetic resonance imaging (fMRI), real-time functional magnetic resonance imaging (rtfMRI), and electroencephalography (EEG) to measure brain activity.

Outcome measures: There is no direct benefit to the participant by joining this study. Data from this study are expected to contribute to a better understanding of the neural processes of cigarette craving. Thus, the results may benefit the health of society. MRI-related risks (e.g., injury from metal implants, claustrophobia, and temporary hearing threshold alterations due to the loud banging noises) and nicotine-patch-related risks (e.g., dizziness, headache, upset stomach, vomiting, diarrhea, redness or swelling at the patch site) to participants are minimized by careful prescreening and standard protection.

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 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

结局指标

主要结局

To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (2)

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