Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task
研究概览
简要总结
The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.
详细描述
In a double-blind, randomized controlled trial, dependent smokers will be randomized to a 6-week very low nicotine content (VLNC) cigarette condition (N=50) or a 6-week normal nicotine content cigarette control condition (NNC; N=25). Participants will undergo functional magnetic resonance imaging (fMRI) scans at baseline and 6-weeks to investigate the nicotine-related modulation of brain circuitry involved in incentive salience valuation and executive control. Imaging tasks will engage the incentive salience of smoking cues and non-smoking rewards and executive control functions to identify changes in functional activity within, and effective connectivity between, known salience and executive control brain circuitry. A novel fMRI task using specialized odor presentation equipment and fMRI sequences will assess neural cue reactivity to smoke odors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-60 years old
- •Smoke >5 cigarettes per day
- •>1 year of daily smoking
- •No quit attempt in prior month and not planning to quit smoking within next 3 months
- •Able to understand and consent to study procedures
- •High school or lower educational attainment or annual household income < $50,000
- •Plan to live in local area next 3 months
- •Women not pregnant or nursing and taking steps to avoid pregnancy
- •Able to read and write in English
- •Access to computer with internet service that allows for Zoom
排除标准
- •Use of non-cigarette tobacco products in the past 7 days
- •Use of illicit substances more than once a week in the past 3 months (excluding marijuana)
- •Current alcohol abuse impairing participation
- •MRI safety contraindications (e.g., metal implants, claustrophobia)
- •Unstable or significant medical conditions (e.g., chronic obstructive pulmonary disorder, coronary heart disease)
- •Major neurological conditions or brain trauma
- •Major surgeries planned in next 3 months
- •Use of smoking cessation medication in prior month (e.g., varenicline, patch)
- •Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
- •Unwillingness to provide urine samples
- •Unwilling to smoke study assigned cigarettes for the remainder of the trial
- •Plans to move or take extended travel out of the area in the next 3 months
- •Any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
- •Self-reported color blindness
- •Left-handedness
- •Smell dysfunction as determined via standardized assessment
研究组 & 干预措施
Very low nicotine content cigarettes
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
干预措施: Very low nicotine content cigarettes (Drug)
Normal nicotine content cigarettes
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
干预措施: Normal nicotine content cigarettes (Drug)
结局指标
主要结局
Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task
时间窗: Change in BOLD signal from baseline to the 6-week visit.
Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.
次要结局
- Change in Percentage of Immediate Choices on Monetary Delay Discounting Task(Changes from baseline to 6-weeks post intervention.)
- Change in Self-reported Cigarettes Per Day(Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.)
研究者
Andrea Hobkirk, PhD
Assistant Professor
Milton S. Hershey Medical Center