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出境医 / 临床实验 / Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Sleep Disturbance Nicotine Dependence | Behavioral: Sleep restriction condition Behavioral: Sleep extension condition | Not Applicable |
Detailed Description:
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal |
| Actual Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | March 1, 2025 |
| Estimated Study Completion Date : | August 1, 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sleep Restriction
4 hours time in bed (1 am to 5 am)
|
Behavioral: Sleep restriction condition
On day 1, participants will complete study assessments and will be fitted with an Actiwatch and instructed to continue a fixed time in bed (8 hours duration with no more than 20 min deviation) centered on habitual sleep (e.g., 11:00 p.m. to 7:00 a.m.). Naps will not be allowed. Following the one-week baseline sleep stabilization, participants will engage in the sleep restriction condition(4 hours, TIB [Time in Bed]; 1:00 a.m. to 5:00 a.m.). On the day of each sleep study, participants will be admitted to University of Alabama Birmingham (UAB) Highlands Hospital sleep unit at 7:00 p.m. and receive a hospital dinner and will be discharged after breakfast served at 8:00 a.m. After each discharge, participants' smoking withdrawals will be monitored. At 7:00 p.m., participants will be re-admitted to UAB Highlands sleep unit, repeating the same conditions on the first night.
|
|
Experimental: Sleep Extension
10 hours time in bed (10 pm to 8 am)
|
Behavioral: Sleep extension condition
sleep extension On day 1, participants will complete study assessments and will be fitted with an Actiwatch and instructed to continue a fixed time in bed (8 hours duration with no more than 20 min deviation) centered on habitual sleep (e.g., 11:00 p.m. to 7:00 a.m.). Naps will not be allowed. Following the one-week baseline sleep stabilization, participants will engage in the sleep extension condition (10 hours, TIB; 10:00 p.m. to 8:00 a.m.). On the day of each sleep study, participants will be admitted to University of Alabama Birmingham (UAB) Highlands Hospital sleep unit at 7:00 p.m. and receive a hospital dinner and will be discharged after breakfast served at 8:00 a.m. After each discharge, participants' smoking withdrawals will be monitored. At 7:00 p.m., participants will be re-admitted to UAB Highlands sleep unit, repeating the same conditions on the first night.
|
Outcome Measures
Primary Outcome Measures :
- Sleep Hygiene Index [ Time Frame: 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)
- Rarely
- Sometimes
- Frequent
- Always (Worst)
Secondary Outcome Measures :
- Pittsburgh Sleep Quality Index [ Time Frame: 6 months ]
A 7-item self-report measure that assesses global sleep quality over the past month. Additionally, sub-scales that include duration of sleep, sleep disturbance, sleep latency, daytime dysfunction, sleep efficiency, and dependence on hypnotic medication may be calculated from individual items
Not during the past month (0; very good) Less than once a week once or twice a week Three or more times a week (3; very bad)
- Munich Chronotype Questionnaire [ Time Frame: 6 months ]Questionnaire that determines chronotype from midsleep time calculated from sleep onset and offset on both free days and work days. Chronotype will be determined from the mid-sleep time on days off . Specifically, Mid-sleep time is equal to Sleep onset + Sleep duration/2. For those who sleep longer on days off than on workdays, we will correct for weekend recovery sleep by subtracting 'sleep debt' accumulated, which is estimated by the following equation: Sleep duration on free days - Sleep duration (average) for the week/2. Chronotype will be categorized by either the median (two categories) or quartiles (to examine more extreme chronotypes).
- Fagerström Test for Nicotine Dependence [ Time Frame: 6 months ]
A 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire
1-2: low dependence 3-4: low to mod dependence 5-7: moderate dependence 8+: high dependence
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older;
- able to read and speak English;
- African American or non-Hispanic White race; and
- either do not smoke (smoked fewer than 100 cigarettes in lifetime and no smoking-not even a puff-in the last year) or smoke at least 5 cigarettes per day for the past year and having smoked >100 cigarettes in lifetime (all Aims) and expire Carbon Monoxide (CO) >10ppm to ensure daily smoking (Aims 2 and 3). This relatively low cutoff was chosen due to the expectation of enrolling a large (~50% of the full sample in Aims 1 and 2), African American group of smokers.
Exclusion Criteria:
- for those who smoke cigarettes, living in a restricted environment that does not allow smoking;
- former smokers (smoked >100 cigarettes in lifetime but no smoking for the past year);
- pregnant or lactating (all women will be required to use an acceptable form of contraception;
- cognitive impairment or untreated mental illness that interferes with informed consent. Individuals stable on medication will be included;
- daily or exclusive use of other tobacco products (e.g., cigars, e-cigarettes); and
- history of a medical condition (e.g., bipolar disorder, migraine or seizure disorder) that might be exacerbated by sleep deprivation as a result of Aim 3.
Contacts and Locations
Contacts
| Contact: Karen Cropsey, PsyD | 2059757809 | kcropsey@uabmc.edu | |
| Contact: Keith r Chichester, BA | 2059757809 | KRC80@UAB.EDU |
Locations
| United States, Alabama | |
| University of Alabama, Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35226 | |
| Contact: Mickeah Hughley, BA 205-975-7809 mickeahhugley@uabmc.edu | |
Sponsors and Collaborators
University of Alabama at Birmingham
University of Oklahoma
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||||||
| First Posted Date ICMJE | May 30, 2019 | ||||||||
| Last Update Posted Date | May 27, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 1, 2021 | ||||||||
| Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Sleep Hygiene Index [ Time Frame: 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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal | ||||||||
| Official Title ICMJE | Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 1, 2025 | ||||||||
| Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03968900 | ||||||||
| Other Study ID Numbers ICMJE | 1288803 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Karen Cropsey, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | University of Oklahoma | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Alabama at Birmingham | ||||||||
| Verification Date | May 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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