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

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ClinicalTrials.gov Identifier: NCT03968900
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

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.

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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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : August 1, 2024

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.




Primary Outcome Measures :
  1. 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)

    1. Rarely
    2. Sometimes
    3. Frequent
    4. Always (Worst)


Secondary Outcome Measures :
  1. 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)


  2. 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).

  3. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. able to read and speak English;
  3. African American or non-Hispanic White race; and
  4. 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:

  1. for those who smoke cigarettes, living in a restricted environment that does not allow smoking;
  2. former smokers (smoked >100 cigarettes in lifetime but no smoking for the past year);
  3. pregnant or lactating (all women will be required to use an acceptable form of contraception;
  4. cognitive impairment or untreated mental illness that interferes with informed consent. Individuals stable on medication will be included;
  5. daily or exclusive use of other tobacco products (e.g., cigars, e-cigarettes); and
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968900


Contacts
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Contact: Karen Cropsey, PsyD 2059757809 kcropsey@uabmc.edu
Contact: Keith r Chichester, BA 2059757809 KRC80@UAB.EDU

Locations
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United States, Alabama
University of Alabama, Birmingham Not yet 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

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Responsible Party: Karen Cropsey, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03968900     History of Changes
Other Study ID Numbers: 1288803
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Cropsey, University of Alabama at Birmingham:
smoking
sleep deficiencies
socioeconomic disadvantage
Race
Additional relevant MeSH terms:
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Sleep Wake Disorders
Dyssomnias
Parasomnias
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action