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临床试验/NCT04281979
NCT04281979招募中不适用

An MRI Study of Neural Activity Following Exposure to a Specific Substance in Young Cigarette Smokers

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Impulsivity

研究概览

简要总结

Although rates of cigarette use are declining, the proportion of nondaily smokers is rising, particularly among young adults. Among young adults, nondaily smoking is associated with negative health consequences and, for some, may lead to the establishment of life-long smoking patterns. The goal of this project is to understand the behavioral, psychological and neurobiological factors that contribute to cigarette use in nondaily smokers to aid the development of tailored evidence-based interventions.

详细描述

The purpose of this study is to investigate the neurobiological mechanisms associated with cigarette use in young nondaily smokers (ages 21-25). Nondaily smokers experience fewer symptoms of cigarette withdrawal than daily smokers; however, they still experience difficulty quitting. Since smoking cessation before the age of 30 substantially attenuates the long-term health consequences associated with smoking, understanding the factors that motivate cigarette use in young nondaily smokers and developing tailored interventions will be critical for curbing cigarette use and improving public health. The proposed project will use functional magnetic resonance imaging (fMRI) to examine how other substances (e.g. stimulates, sedatives, or analgesics) impact brain function and will assess the extent to which substance-induced changes in brain function correlate with impulsive choice, cigarette craving, and craving regulation in young adults. Furthermore, the investigators will assess how substance-induced changes in brain function, impulsivity, craving, and capacity for craving regulation predict cigarette use over the course of 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

In each of the two conditions, participants will be asked to consume a drink and pill. They will be informed that the drink and pill may contain a variety of over the counter substances but they will not be informed about the contents of the drinks and pills until they have completed both the active and placebo visits.

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be 21-40 years old
  • Right-handed
  • Fluent in English
  • Report smoking cigarettes or e-cigarettes 1-27 days in the past month
  • Report binge drinking based on NIAAA criteria (5 or more drinks per occasion for males, 4 or more drinks per occasion for females) at least 1 time in the past 90 days without adverse incident

排除标准

  • Seeking treatment for substance use (e.g. nicotine or alcohol use)
  • Moderate or Severe Nicotine Dependence
  • Current alcohol use disorder
  • Illicit substance use other than marijuana use in the past year
  • Marijuana use more than 10 times in the past year
  • Major neurological or medical illness - Significant head trauma - Current use of medication affecting the central nervous system
  • MRI contraindications (e.g. irremovable metal on the body or pregnancy)

研究组 & 干预措施

Study Agent

Experimental

干预措施: Study Agent (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Impulsivity

时间窗: Immediately after beverage/capsule consumption

Impulsivity will be measured by assessing behavior on a temporal discounting task.

Resting State Functional Connectivity

时间窗: 35 minutes after beverage/capsule consumption

Brain function will be measured while participants are resting using functional magnetic resonance imaging

Cigarette Craving and Associated Brain Activation

时间窗: 50 minutes after beverage/capsule consumption

Brain function will be measured using functional magnetic resonance imaging while participants complete a Craving Regulation Task

Symptoms of Cigarette Dependence

时间窗: 1 year follow-up from baseline

The Fagerström Test of Nicotine Dependence total score will be used to measure changes in cigarette dependence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angelica Morales

Assistant Professor

Oregon Health and Science University

研究点 (1)

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