Smoking Cessation and Brain Activation: How Practice Changes the Brain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues
研究概览
简要总结
The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.
详细描述
The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Primary investigator was blinded to intervention assignment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smoke > 10 cigarettes per day for the last 6 months
- •Smokes first cigarette within 60 minutes after waking
- •Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
- •Willing to complete all appointments and change smoking behaviors for 2 weeks
- •No quit attempts or attempts to cut back in the last 30 days
- •No plans to quit in the next 30 days
- •High school graduate or General Eduction Diploma (GED)
排除标准
- •Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
- •Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
- •Currently taking anti-seizure medication
- •History of concussion
- •Body mass index (BMI) over 50
- •Left-handedness
- •History of alcohol or other substance dependence or current abuse;
- •Risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
- •Pregnancy
结局指标
主要结局
Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues
时间窗: Baseline (Day 7) to End of Study (Day 22)
Change measured via functional magnetic resonance imaging (fMRI)
次要结局
- Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues(Baseline (Day 7) to End of Study (Day 22))