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临床试验/NCT01505725
NCT01505725已完成不适用

Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年3月16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
92
试验地点
1
主要终点
Choice of nicotine cigarettes; cue-elicited craving

研究概览

简要总结

Background:

  • Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers are interested in learning more about how nicotine affects current smokers' responses to psychological tests and smoking-related cues, and in studying whether certain kinds of genetic background may affect smokers' responses to these kinds of studies.

Objectives:

  • To compare the effect of nicotine versus denicotinized cigarettes during specific psychological tests.
  • To compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic response.
  • To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.

Eligibility:

  • Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes per day for at least 1 year) and are not currently interested in reducing their smoking or seeking treatment for tobacco dependence.

Design:

  • Pilot session:
  • Participants will practice smoking using the measuring equipment that will be used in the study.
  • After successful practice, participants will read or listen to music for 1 hour, during which they are not allowed to smoke.
  • After the 1-hour period, participants will sample study cigarettes that have different levels of nicotine, and will be asked to guess whether the cigarettes are normal study cigarettes or denicotinized cigarettes.
  • Baseline session:
  • Blood, urine, and breath samples will be taken at the start of the session.
  • Participants will smoke part of an initial cigarette, and then will read or listen to music for 1 hour, during which they are not allowed to smoke.
  • After the 1-hour period, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
  • Trial sessions:
  • Participants will smoke study cigarettes, and will be asked to either respond to questions about perceived nicotine levels in the cigarettes or press a lever for the chance to be rewarded with additional puffs of the cigarette. After the session, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
  • Participants will also participate in cue-reactivity sessions to test the body's physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack of unsharpened pencils). After the session, participants will complete questionnaires on mood and concentration 15, 30, 45, and 60 minutes after the session.
  • At the conclusion of the last experimental session, participants will discuss the study with researchers, and may receive a referral list of smoking treatment programs.

详细描述

Objectives: 1) to compare the reinforcing efficacy of nicotine versus denicotinized cigarettes using a forced choice and an operant response procedure, 2) to compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic responsivity, and 3) to explore potential associations between several genetic polymorphisms and the phenotypic measures of nicotine reinforcement and smoking-cue reactivity.

Study population: 175 adult smokers (35 for pilot study I, 60 for pilot stufy II and 80 for main study).

Design: Placebo-controlled, within-subjects design. Pilot studies will entail 1-2 sessions. Main study will entail one baseline/adaptation session and 5-10 experimental sessions.

Outcome Measures:

Behavioral Measures

研究设计

研究类型
Observational
时间视角
Other

入排标准

年龄范围
18 Years 至 64 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

Choice of nicotine cigarettes; cue-elicited craving

次要结局

  • smoking history measures; variants of several genes related to nicotine additions

研究者

申办方类型
Nih

研究点 (1)

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