Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Blood Oxygen Level Dependent (BOLD) Activation
研究概览
简要总结
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Right-handed
- •Smoke >= 10 cigarettes per day
- •Smoking regularly for >= 1 year
- •Carbon Monoxide (CO) > 8 at screening (or urinary cotinine > 100)
- •Own a compatible smartphone
- •Able to read and understand English
- •Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking
排除标准
- •Regular use of "roll your own" cigarettes
- •Planning to quit smoking within the next 60 days
- •Current or planned smoking cessation treatment
- •Regular use of smokeless tobacco or other nicotine products
- •Expired CO > 80 parts per million
- •Breath alcohol > .000 at screening (re-attempts are allowed)
- •Positive toxicology screen for exclusionary drugs
- •Use of exclusionary medications
- •Significant medical problems
- •Currently breastfeeding, pregnant, or planning to become pregnant
- •Enrollment in another study utilizing Spectrum cigarettes within the last 3 months
- •Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)
结局指标
主要结局
Blood Oxygen Level Dependent (BOLD) Activation
时间窗: Approximately 1-3 weeks
BOLD activation in brain reward network regions
Ecological Momentary Assessment (EMA) Pleasure Ratings
时间窗: 2-6 weeks
Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.
次要结局
未报告次要终点