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临床试验/NCT03948893
NCT03948893招募中不适用

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

University of Missouri-Columbia4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
4
主要终点
Magnitude of change in fMRI brain response to images

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18 and up
  • English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks
  • Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
  • Current nicotine dependent smoker with a minimum smoking history of 2 years
  • Interest in quitting smoking

排除标准

  • Use of psychotropic (e.g. antiepileptic) medications in the past month
  • Positive urine drug screen
  • Presence of an untreated medical illness
  • Current or past psychosis
  • History of major neurological illness or head injury resulting in loss of consciousness
  • And contraindication to MRI, including claustrophobia
  • Among females, positive urine pregnancy test
  • Inability or unwillingness of subject to give informed consent

结局指标

主要结局

Magnitude of change in fMRI brain response to images

时间窗: 7 weeks

Measure the effects of MORE on fMRI BOLD response to images (change from baseline to end of study) while participants undergo functional magnetic resonance imaging

Magnitude of change in fMRI brain connectivity

时间窗: 7 weeks

Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.

Cigarette Smoking

时间窗: 7 weeks

Biochemical smoking assessment (breath carbon monoxide) at each study visit.

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

Brett Froeliger

Professor Psychiatry

University of Missouri-Columbia

研究点 (4)

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