Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

Smoking Clinical Trial

Official title:

Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968900
• Other study ID #: 1288803
• Secondary ID: R01DA046096
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Melinda Clarke, MS
• Phone: 2059757809
• Email: melindaclarke[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

6. Non-English speaking

7. Lives in restricted environment that does not allow smoking

8. Pregnant or lactating

9. Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed

10. 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

11. Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes

12. Participants would work outside normal 7 a.m. to 6 p.m. hours

13. Former smokers

14. 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

15. 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)

16. Cognitive impairment such that participant is unable to provide informed consent

17. Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent

18. Living outside of the Birmingham metro area (> 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)

Related Conditions & MeSH terms

• Nicotine Dependence
• Sleep Disturbance
• Smoking
• Tobacco Use Disorder

Intervention

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 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.
• 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 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.

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Drug Abuse (NIDA), University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duke- The University of North Carolina at Chapel Hill (UNC) Functional Social Support Questionnaire (FSSQ)	A 8-item 1-5 Likert scale ranging from "much less than I would like" to "as much as I would like" that measures perceived social support	6 months
Other	Patient Health Questionnaire (PHQ-9)	A 9-item instrument that measures severity of depression as well as the presence and suicide ideation	6 months
Other	Generalized Anxiety Disorder (GAD-7)	A 7-item anxiety scale used to identify probable cases of generalized anxiety disorder	6 months
Other	Assessing Smoking History	Smoking history will be assessed for daily smokers as smoking 5 or more cigarettes a day for the past one year and having smoked more than 100 cigarettes in lifetime or non-smoker defined as smoking fewer than 100 cigarettes in a lifetime and no smoking-not even a puff- in the last year	6 months
Other	Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM-37)	The Brief WISDM has 37 items that load onto 11 subscales. The psychometric properties of the reduced-item WISDM subscales is comparable to the WISDM-68. For Aims 1 & 2, Smokers only.	6 months
Other	Tobacco Craving Questionnaire-SF (TCQ-SF)	The TCQ-SF contains 12 items to assess participants' craving to smoke cigarettes.For Aims 1 & 2, Smokers only.	6 months
Other	Modified Alcohol, Smoking, and Substance Involvement Screening Test v2.0 (ASSIST)	The MNWS is an 8-item measure designed to assess Smokers' cigarette withdrawal in the last 24 hours. For Aims 1 & 2, Smokers only.	6 months
Other	Minnesota Nicotine Withdrawal Scale (MNWS).	The MNWS is an 8-item measure designed to assess Smokers' cigarette withdrawal in the last 24 hours. For Aims 1 & 2, Smokers only.	6 months
Other	Alcohol Use Disorders Identification Test-Concise (AUDIT-C).	A brief 3-item alcohol screening measure that identifies hazardous drinkers or those who have active alcohol use disorders.	6 months
Other	Pain, Enjoyment, General Activity (PEG) Scale	The PEG Scale contains 3 questions regarding how much pain has interfered with enjoyment of life and general activity in the past 7 days.	6 months
Other	Trauma History Scale (THS)	The THS is a brief 14-item self-report measure designed to assess traumatic events and how much those events are emotionally bothersome.	6 months
Other	PTSD Checklist-Short Form (PCL-5)	The short form of the 20-item PCL-5 which assesses the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD in the past month. The short form contains 4 items.	6 months
Other	International Consultation on Incontinence Questionnaire-Overactive Bladder & -Urinary Incontinence Short Form	8 items pertaining to overactive bladder symptoms and urinary incontinence experienced in the past 4 weeks.	6 months
Other	International Physical Activity Questionnaire (IPAQ)	A set of questionnaires designed to assess physical activity and sedentary lifestyles.	6 months
Other	Standard Shiftwork Index (SSI)	A battery of self-report questionnaires measuring shift workers' sleep and stress outcomes. We are using the physical health subsections of this questionnaire	6 months
Other	Fatigue Severity Scale (FSS)	A 9-item scale measuring severity of fatigue and its effect on participants' activities and lifestyle.	6 months
Other	Continuous positive airway pressure (CPAP) Questionnaire	A 5-item survey designed by the research team to assess whether or not participants are prescribed CPAP, and their adherence to using it	6 months
Primary	Sleep Hygiene Index	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)	6 months
Secondary	Pittsburgh Sleep Quality Index	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)	6 months
Secondary	Munich Chronotype Questionnaire	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).	6 months
Secondary	Fagerström Test for Nicotine Dependence	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	6 months
Secondary	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	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	6 months
Secondary	Insomnia Severity Index	A 7-item self-report questionnaire that assesses the severity of core symptoms of insomnia over the previous 2 weeks	6 months
Secondary	Dysfunctional Beliefs and Attitudes About Sleep (DBAS)	A 16-item questionnaire that assesses beliefs about sleep and the consequences of poor sleep	6 months
Secondary	Epworth Sleepiness Scale (ESS)	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	6 months
Secondary	Everyday Discrimination Scale (EDS)	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"	6 months
Secondary	Perceived Stress Scale - 10 Item (PSS-10)	Self-report questionnaire that assesses a person's perceived stress with a 5-point Likert scale ranging from "Never" to "Very Often"	6 months