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Completed
NCT03968900
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Conditions: Smoking, Sleep Disturbance, Nicotine Dependence
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 29
Sponsor: University of Alabama at Birmingham
Location: University of Alabama, Birmingham Birmingham Alabama
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.
Eligibility Criteria
Sub-Study 1
Inclusion Criteria:
1. 18 years or older
2. Able to read and speak English
3. Non-Hispanic African American (Black) or non-Hispanic white race
4. 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)
5. Currently residing in Alabama
Exclusion Criteria:
6. Non-English speaking
7. Lives in restricted environment that does not allow smoking
8. Pregnant or lactating
9. 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
10. Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
11. Participants would work outside normal 7 a.m. to 6 p.m. hours
12. Former smokers
Sub-study 2
Inclusion Criteria:
1. 18 years or older
2. Able to read and speak English
3. Non-Hispanic African American (Black) or non-Hispanic white race
4. 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)\ 20 miles away from University of Alabama at Birmingham Main Campus)
Sub-study 3
Inclusion Criteria:
1. 18 years or older
2. Able to read and speak English
3. Non-Hispanic African American (Black) or non-Hispanic white race
4. 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
5. Currently residing in Alabama
Exclusion Criteria:
6. Non-English speaking
7. Lives in restricted environment that does not allow smoking
8. Pregnant or lactating
9. 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
10. Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
11. Participants would work outside normal 7 a.m. to 6 p.m. hours
12. Former smokers
13. 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
14. Currently taking any psychiatric medications, pain medications (i.e., opioids), or sleep medications (e.g., Ambien, trazodone, melatonin pills, Cannabidiol (CBD) products)
15. History of a serious lung/breathing disease that prevents one from walking or holding their breath for 10 seconds
16. Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
17. Has an apnea-hypopnea index (AHI) score of \> 15 on home sleep testing that was conducted during sub-study 2
18. Uses Continuous positive airway pressure (CPAP) machine to sleep at night
19. Cognitive impairment such that participant is unable to provide informed consent
20. Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
21. Living outside of the Birmingham metro area (\> 20 miles away from University of Alabama at Birmingham Main Campus)
Source: ClinicalTrials.gov (NCT03968900). StuddyBuddy aggregates publicly available trial information.