Back to resultsRacial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Primary Purpose
Smoking, Sleep Disturbance, Nicotine Dependence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep restriction condition
Sleep extension condition
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring smoking, sleep deficiencies, socioeconomic disadvantage, Race
Eligibility Criteria
Sub-Study 1
Inclusion Criteria:
- 18 years or older
- Able to read and speak English
- Non-Hispanic African American (Black) or non-Hispanic white race
- 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)
Currently residing in Alabama
Exclusion Criteria:
- Non-English speaking
- Lives in restricted environment that does not allow smoking
- Pregnant or lactating
- 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
- Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- Participants would work outside normal 7 a.m. to 6 p.m. hours
- Former smokers
Sub-study 2
Inclusion Criteria:
- 18 years or older
- Able to read and speak English
- Non-Hispanic African American (Black) or non-Hispanic white race
- 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.
Currently residing in Alabama
Exclusion Criteria:
- Non-English speaking
- Lives in restricted environment that does not allow smoking
- Pregnant or lactating
- Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
- 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
- Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- Participants would work outside normal 7 a.m. to 6 p.m. hours
- Former smokers
- 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
- 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)
- Cognitive impairment such that participant is unable to provide informed consent
- Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
- Living outside of the Birmingham metro area (> 20 miles away from University of Alabama at Birmingham Main Campus)
Sub-study 3
Inclusion Criteria:
- 18 years or older
- Able to read and speak English
- Non-Hispanic African American (Black) or non-Hispanic white race
- 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
Currently residing in Alabama
Exclusion Criteria:
- Non-English speaking
- Lives in restricted environment that does not allow smoking
- Pregnant or lactating
- 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
- Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
- Participants would work outside normal 7 a.m. to 6 p.m. hours
- Former smokers
- 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
- Currently taking any psychiatric medications, pain medications (i.e., opioids), or sleep medications (e.g., Ambien, trazodone, melatonin pills, Cannabidiol (CBD) products)
- History of a serious lung/breathing disease that prevents one from walking or holding their breath for 10 seconds
- Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
- Has an apnea-hypopnea index (AHI) score of > 15 on home sleep testing that was conducted during sub-study 2
- Uses Continuous positive airway pressure (CPAP) machine to sleep at night
- Cognitive impairment such that participant is unable to provide informed consent
- Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
- Living outside of the Birmingham metro area (> 20 miles away from University of Alabama at Birmingham Main Campus)
Sites / Locations
- University of Alabama, BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sleep Restriction
Sleep Extension
Arm Description
4 hours time in bed (1 am to 5 am)
10 hours time in bed (10 pm to 8 am)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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).
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
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
Insomnia Severity Index
A 7-item self-report questionnaire that assesses the severity of core symptoms of insomnia over the previous 2 weeks
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
A 16-item questionnaire that assesses beliefs about sleep and the consequences of poor sleep
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
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"
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"
Full Information
NCT ID
NCT03968900
First Posted
May 23, 2019
Last Updated
May 24, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT03968900
Brief Title
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Official Title
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Sleep Disturbance, Nicotine Dependence
Keywords
smoking, sleep deficiencies, socioeconomic disadvantage, Race
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep Restriction
Arm Type
Experimental
Arm Description
4 hours time in bed (1 am to 5 am)
Arm Title
Sleep Extension
Arm Type
Experimental
Arm Description
10 hours time in bed (10 pm to 8 am)
Intervention Type
Behavioral
Intervention Name(s)
Sleep restriction condition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Hygiene Index
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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)
Time Frame
6 months
Title
Munich Chronotype Questionnaire
Description
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).
Time Frame
6 months
Title
Fagerström Test for Nicotine Dependence
Description
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
Time Frame
6 months
Title
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
Description
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
Time Frame
6 months
Title
Insomnia Severity Index
Description
A 7-item self-report questionnaire that assesses the severity of core symptoms of insomnia over the previous 2 weeks
Time Frame
6 months
Title
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Description
A 16-item questionnaire that assesses beliefs about sleep and the consequences of poor sleep
Time Frame
6 months
Title
Epworth Sleepiness Scale (ESS)
Description
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
Time Frame
6 months
Title
Everyday Discrimination Scale (EDS)
Description
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"
Time Frame
6 months
Title
Perceived Stress Scale - 10 Item (PSS-10)
Description
Self-report questionnaire that assesses a person's perceived stress with a 5-point Likert scale ranging from "Never" to "Very Often"
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Duke- The University of North Carolina at Chapel Hill (UNC) Functional Social Support Questionnaire (FSSQ)
Description
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
Time Frame
6 months
Title
Patient Health Questionnaire (PHQ-9)
Description
A 9-item instrument that measures severity of depression as well as the presence and suicide ideation
Time Frame
6 months
Title
Generalized Anxiety Disorder (GAD-7)
Description
A 7-item anxiety scale used to identify probable cases of generalized anxiety disorder
Time Frame
6 months
Title
Assessing Smoking History
Description
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
Time Frame
6 months
Title
Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM-37)
Description
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.
Time Frame
6 months
Title
Tobacco Craving Questionnaire-SF (TCQ-SF)
Description
The TCQ-SF contains 12 items to assess participants' craving to smoke cigarettes.For Aims 1 & 2, Smokers only.
Time Frame
6 months
Title
Modified Alcohol, Smoking, and Substance Involvement Screening Test v2.0 (ASSIST)
Description
The MNWS is an 8-item measure designed to assess Smokers' cigarette withdrawal in the last 24 hours. For Aims 1 & 2, Smokers only.
Time Frame
6 months
Title
Minnesota Nicotine Withdrawal Scale (MNWS).
Description
The MNWS is an 8-item measure designed to assess Smokers' cigarette withdrawal in the last 24 hours. For Aims 1 & 2, Smokers only.
Time Frame
6 months
Title
Alcohol Use Disorders Identification Test-Concise (AUDIT-C).
Description
A brief 3-item alcohol screening measure that identifies hazardous drinkers or those who have active alcohol use disorders.
Time Frame
6 months
Title
Pain, Enjoyment, General Activity (PEG) Scale
Description
The PEG Scale contains 3 questions regarding how much pain has interfered with enjoyment of life and general activity in the past 7 days.
Time Frame
6 months
Title
Trauma History Scale (THS)
Description
The THS is a brief 14-item self-report measure designed to assess traumatic events and how much those events are emotionally bothersome.
Time Frame
6 months
Title
PTSD Checklist-Short Form (PCL-5)
Description
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.
Time Frame
6 months
Title
International Consultation on Incontinence Questionnaire-Overactive Bladder & -Urinary Incontinence Short Form
Description
8 items pertaining to overactive bladder symptoms and urinary incontinence experienced in the past 4 weeks.
Time Frame
6 months
Title
International Physical Activity Questionnaire (IPAQ)
Description
A set of questionnaires designed to assess physical activity and sedentary lifestyles.
Time Frame
6 months
Title
Standard Shiftwork Index (SSI)
Description
A battery of self-report questionnaires measuring shift workers' sleep and stress outcomes. We are using the physical health subsections of this questionnaire
Time Frame
6 months
Title
Fatigue Severity Scale (FSS)
Description
A 9-item scale measuring severity of fatigue and its effect on participants' activities and lifestyle.
Time Frame
6 months
Title
Continuous positive airway pressure (CPAP) Questionnaire
Description
A 5-item survey designed by the research team to assess whether or not participants are prescribed CPAP, and their adherence to using it
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Sub-Study 1
Inclusion Criteria:
18 years or older
Able to read and speak English
Non-Hispanic African American (Black) or non-Hispanic white race
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)
Currently residing in Alabama
Exclusion Criteria:
Non-English speaking
Lives in restricted environment that does not allow smoking
Pregnant or lactating
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
Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
Participants would work outside normal 7 a.m. to 6 p.m. hours
Former smokers
Sub-study 2
Inclusion Criteria:
18 years or older
Able to read and speak English
Non-Hispanic African American (Black) or non-Hispanic white race
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.
Currently residing in Alabama
Exclusion Criteria:
Non-English speaking
Lives in restricted environment that does not allow smoking
Pregnant or lactating
Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
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
Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
Participants would work outside normal 7 a.m. to 6 p.m. hours
Former smokers
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
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)
Cognitive impairment such that participant is unable to provide informed consent
Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
Living outside of the Birmingham metro area (> 20 miles away from University of Alabama at Birmingham Main Campus)
Sub-study 3
Inclusion Criteria:
18 years or older
Able to read and speak English
Non-Hispanic African American (Black) or non-Hispanic white race
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
Currently residing in Alabama
Exclusion Criteria:
Non-English speaking
Lives in restricted environment that does not allow smoking
Pregnant or lactating
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
Currently receiving smoking cessation treatment or using electronic cigarettes or other tobacco to try and quit smoking cigarettes
Participants would work outside normal 7 a.m. to 6 p.m. hours
Former smokers
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
Currently taking any psychiatric medications, pain medications (i.e., opioids), or sleep medications (e.g., Ambien, trazodone, melatonin pills, Cannabidiol (CBD) products)
History of a serious lung/breathing disease that prevents one from walking or holding their breath for 10 seconds
Testing positive on urine drug screen test at baseline - any drugs other than Tetrahydrocannabinol (THC) not allowed
Has an apnea-hypopnea index (AHI) score of > 15 on home sleep testing that was conducted during sub-study 2
Uses Continuous positive airway pressure (CPAP) machine to sleep at night
Cognitive impairment such that participant is unable to provide informed consent
Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent
Living outside of the Birmingham metro area (> 20 miles away from University of Alabama at Birmingham Main Campus)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Cropsey, PsyD
Phone
2059757809
Email
kcropsey@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Keith r Chichester, BA
Phone
2059757809
Email
KRC80@UAB.EDU
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickeah Hughley, BA
Phone
205-975-7809
Email
mickeahhugley@uabmc.edu
12. IPD Sharing Statement
Learn more about this trial
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
We'll reach out to this number within 24 hrs