Nicotine Dependence, Sleep Disturbance, Smoking
Conditions
Keywords
smoking, sleep deficiencies, socioeconomic disadvantage, Race
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.
Interventions
BEHAVIORALSleep 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 do an initial CO breathe test and fill out study questionnaires and a timeline follow-back procedure Participants will monitored for smoking withdrawal. Every 2 hours, participants to fill out various questionnaires. Participants will repeat the same conditions as the first night. After a two-week washout, participants will be crossed over to the alternate sleep extension/restriction condition.
BEHAVIORALSleep 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 Highlands Hospital sleep unit at 7:00 p.m. and do an initial CO breathe test and fill out study questionnaires and a timeline follow-back procedure Participants will monitored for smoking withdrawal. Every 2 hours, participants to fill out various questionnaires. Participants will repeat the same conditions as the first night. After a two-week washout, participants will be crossed over to the alternate sleep extension/restriction condition.
Sponsors
University of Alabama at Birmingham
University of Oklahoma
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)\<3 ppm and negative cotinine test. 5. Currently residing in Alabama
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Hygiene Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | 1 day at baseline before either intervention | 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. Higher scores indicate worse sleep quality. The minimum score is 0, and the maximum score is 21. |
| Munich Chronotype Questionnaire | 1 day at baseline before either intervention | 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 is the participant's midsleep time on free days. Higher values indicate that midsleep time is later in the day. The minimum value is 0, and the maximum value is 24. |
| Fagerström Test for Nicotine Dependence | 1 day at baseline before either intervention | A 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire. Higher scores indicate greater nicotine dependence. The minimum value is 1, and the maximum value is 10. |
| 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 | A 8-item self-report questionnaire that assesses the primary risk factors for obstructive sleep apnea to create a total score that ranges from 0 to 8. Higher scores indicate greater risk of sleep apnea. |
| Insomnia Severity Index | 1 day at baseline before either intervention | A 7-item self-report questionnaire that assesses the severity of core symptoms of insomnia over the previous 2 weeks. Higher scores indicate more severe insomnia. The minimum score is 0, and the maximum score is 28. |
| Dysfunctional Beliefs and Attitudes About Sleep (DBAS) | 1 day at baseline before either intervention | A 16-item questionnaire that assesses beliefs about sleep and the consequences of poor sleep. Higher scores indicate more dysfunctional beliefs about sleep. The minimum score is 0, and the maximum score is 10. |
| Epworth Sleepiness Scale (ESS) | 1 day at baseline before either intervention | A 8-item questionnaire that asks individuals to rate their "chances of dozing off" on a scale of 0 (never) to 3 (high) in eight different situations. The scores are summed to create a total score with higher values indicating higher chances of dozing off. The minimum score is 0, and the maximum score is 24. |
| Everyday Discrimination Scale (EDS) | 1 day at baseline before either intervention | This 9-item assessment queries about experiences of discrimination such as being treated less respectfully or people thinking that you are dishonest. Responses range from "almost every day" to "never." Higher score indicate more ways that discrimination was experienced. The minimum score is 0, and the maximum score is 9. |
| Perceived Stress Scale - 10 Item (PSS-10) | 1 day at baseline before either intervention | Self-report questionnaire that assesses a person's perceived stress with a 5-point Likert scale ranging from "Never" to "Very Often." Higher scores indicate greater levels of perceived stress. The minimum score is 0, and the maximum score is 40. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren L Cropsey, Psy.D.
University of Alabama at Birmingham
Participant flow
Pre-assignment details
Enrollment occurred at the same time as group assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.14 years STANDARD_DEVIATION 10.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
None listed