Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Sleep Hygiene Index
研究概览
简要总结
The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.
详细描述
Three specific aims will determine: contributions of sleep timing and sleep quality and quantity to racial disparities in smoking status (Aim 1), objective sleep characteristics and smoking behavior among blacks and whites who smoke cigarettes (Aim 2), and whether sleep restriction modifies craving and withdrawal in racially diverse smokers (Aim 3). Specifically, we will utilize self-report questionnaires, objective measures of sleep quality and timing (actigraphy) and circadian phase (dim light melatonin onset), as well as ecological momentary assessment of cigarette use, smoking urges, cravings, and withdrawal symptoms to identify circadian and sleep characteristics that are most strongly associated with smoking status, heaviness of smoking and dependence among blacks and whites. Finally, we will test whether acute sleep restriction (4 hours of time-in-bed) versus sleep extension (10 hours of time-in-bed) modifies craving and withdrawal symptoms following cessation in black and white smokers. If successful, the results of this study will result in identification of circadian dysfunction and insufficient sleep as mechanisms that underlie the association between sleep and cigarette smoking behaviors and dependence in diverse populations. Moreover, these findings are likely to inform clinicians of the importance of sleep and sleep timing on cigarette smoking behaviors and dependence that will help in the development of novel interventions to reduce morbidity and mortality caused by tobacco use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-Study 1
- •Inclusion Criteria:
- •18 years or older
- •Able to read and speak English
- •Non-Hispanic African American (Black) or non-Hispanic white race
- •Daily smoker (5 or more cigarettes a day for the past one year and having smoked more than 100 cigarettes in lifetime) or non-smoker (smoked fewer than 100 cigarettes in a lifetime and no smoking-not even a puff- in the last year)
- •Currently residing in Alabama
排除标准
- •Non-English speaking
- •Lives in restricted environment that does not allow smoking
- •Pregnant or lactating
- •Daily or exclusive use of other tobacco products (e.g., cigars, e-cigarettes) if a smoker; if non-smoker, any other tobacco product use is exclusionary
- •Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- •Participants would work outside normal 7 a.m. to 6 p.m. hours
- •Former smokers
- •Sub-study 2
- •Inclusion Criteria:
- •18 years or older
- •Able to read and speak English
- •Non-Hispanic African American (Black) or non-Hispanic white race
- •Daily smoker defined as smoking 5 or more cigarettes a day for the past one year and having smoked more than 100 cigarettes in lifetime, as well as by an expired Carbon Monoxide (CO )cut-off of Carbon Monoxide (CO)>10ppm and positive cotinine test to ensure daily smoking OR non-smoker defined as smoking fewer than 100 cigarettes in a lifetime and no smoking-not even a puff- in the last year, as well as by an expired Carbon monoxide (CO) cut-off of Carbon Monoxide (CO)<3 ppm and negative cotinine test.
- •Currently residing in Alabama
- •Exclusion Criteria:
- •Non-English speaking
- •Lives in restricted environment that does not allow smoking
- •Pregnant or lactating
- •Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
- •Daily or exclusive use of other tobacco products (e.g., cigars, e-cigarettes) if a smoker; if non-smoker, any other tobacco product use is exclusionary
- •Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- •Participants would work outside normal 7 a.m. to 6 p.m. hours
- •Former smokers
- •History of a medical condition (e.g., bipolar disorder, migraine, or seizure disorder) that might be exacerbated by sleep deprivation as a result of Study 3
- •History of a serious lung/breathing disease that prevents one from walking or holding their breath for 10 seconds (in order to complete Carbon Monoxide breath test)
- •Cognitive impairment such that participant is unable to provide informed consent
- •Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
- •Living outside of the Birmingham metro area (> 20 miles away from University of Alabama at Birmingham Main Campus)
- •Sub-study 3
- •Inclusion Criteria:
- •18 years or older
- •Able to read and speak English
- •Non-Hispanic African American (Black) or non-Hispanic white race
- •Daily smoker defined as smoking 5 or more cigarettes a day for the past one year and having smoked more than 100 cigarettes in lifetime, as well as by an expired Carbon Monoxide (CO) cut-off of Carbon Monoxide (CO)>10ppm and positive cotinine test to ensure daily smoking
- •Currently residing in Alabama
- •Exclusion Criteria:
- •Non-English speaking
- •Lives in restricted environment that does not allow smoking
- •Pregnant or lactating
- •Daily or exclusive use of other tobacco products (e.g., cigars, e-cigarettes) if a smoker; if non-smoker, any other tobacco product use is exclusionary
- •Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- •Participants would work outside normal 7 a.m. to 6 p.m. hours
- •Former smokers
- •History of a medical condition (e.g., bipolar disorder, migraine, or seizure disorder) that might be exacerbated by sleep deprivation as a result of Study 3
- •Currently taking any psychiatric medications, pain medications (i.e., opioids), or sleep medications (e.g., Ambien, trazodone, melatonin pills, Cannabidiol (CBD) products)
- •History of a serious lung/breathing disease that prevents one from walking or holding their breath for 10 seconds
- •Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
- •Has an apnea-hypopnea index (AHI) score of > 15 on home sleep testing that was conducted during sub-study 2
- •Uses Continuous positive airway pressure (CPAP) machine to sleep at night
- •Cognitive impairment such that participant is unable to provide informed consent
- 另有 2 项未显示
研究组 & 干预措施
Sleep Restriction
4 hours time in bed (1 am to 5 am)
干预措施: Sleep restriction condition (Behavioral)
Sleep Extension
10 hours time in bed (10 pm to 8 am)
干预措施: Sleep extension condition (Behavioral)
结局指标
主要结局
Sleep Hygiene Index
时间窗: 6 months
A 13-item scale that assesses behaviors, such as variability in wake-time, timing of physical activity, and substance use, that comprise sleep hygiene 0: Never (Best) 1. Rarely 2. Sometimes 3. Frequent 4. Always (Worst)
Sleep Hygiene Index
时间窗: 1 day at baseline
A 13-item scale that assesses behaviors, such as variability in wake-time, timing of physical activity, and substance use, that comprise sleep hygiene. Higher values indicate worse sleep hygiene. The minimum value is 0, and the maximum value is 52.
Sleep Hygiene Index
时间窗: 1 day at baseline before either intervention
A 13-item scale that assesses behaviors, such as variability in wake-time, timing of physical activity, and substance use, that comprise sleep hygiene. Higher values indicate worse sleep hygiene. The minimum value is 0, and the maximum value is 52.
次要结局
- Everyday Discrimination Scale (EDS)(6 months)
- Pittsburgh Sleep Quality Index(6 months)
- Fagerström Test for Nicotine Dependence(6 months)
- Munich Chronotype Questionnaire(6 months)
- Epworth Sleepiness Scale (ESS)(6 months)
- Snoring history, Tired during the day, Observed stop breathing while sleep, High blood pressure, BMI more than 35 kg/m2, Age more than 50 years, Neck circumference more than 40 cm and male Gender (STOP-BANG) Questionnaire(6 months)
- Insomnia Severity Index(6 months)
- Dysfunctional Beliefs and Attitudes About Sleep (DBAS)(6 months)
- Perceived Stress Scale - 10 Item (PSS-10)(6 months)
- Pittsburgh Sleep Quality Index(1 day at baseline)
- Munich Chronotype Questionnaire(1 day at baseline)
- Fagerström Test for Nicotine Dependence(1 day at baseline)
- Snoring History, Tired During the Day, Observed Stop Breathing While Sleep, High Blood Pressure, BMI More Than 35 kg/m2, Age More Than 50 Years, Neck Circumference More Than 40 cm and Male Gender (STOP-BANG) Questionnaire(1 day at baseline)
- Insomnia Severity Index(1 day at baseline)
- Dysfunctional Beliefs and Attitudes About Sleep (DBAS)(1 day at baseline)
- Epworth Sleepiness Scale (ESS)(1 day at baseline)
- Everyday Discrimination Scale (EDS)(1 day at baseline)
- Perceived Stress Scale - 10 Item (PSS-10)(1 day at baseline)
- Pittsburgh Sleep Quality Index(1 day at baseline before either intervention)
- Munich Chronotype Questionnaire(1 day at baseline before either intervention)
- Fagerström Test for Nicotine Dependence(1 day at baseline before either intervention)
- Snoring History, Tired During the Day, Observed Stop Breathing While Sleep, High Blood Pressure, BMI More Than 35 kg/m2, Age More Than 50 Years, Neck Circumference More Than 40 cm and Male Gender (STOP-BANG) Questionnaire(1 day at baseline before either intervention)
- Insomnia Severity Index(1 day at baseline before either intervention)
- Dysfunctional Beliefs and Attitudes About Sleep (DBAS)(1 day at baseline before either intervention)
- Epworth Sleepiness Scale (ESS)(1 day at baseline before either intervention)
- Everyday Discrimination Scale (EDS)(1 day at baseline before either intervention)
- Perceived Stress Scale - 10 Item (PSS-10)(1 day at baseline before either intervention)
研究者
Karen Cropsey
Associate Professor
University of Alabama at Birmingham