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

NCT03968900 | Active Not Recruiting DMC

• 2 other identifiers: 1288803R01DA046096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Sleep Disturbance; Nicotine Dependence

Keywords

smoking; sleep deficiencies; socioeconomic disadvantage; Race

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (9)

• Pittsburgh Sleep Quality Index

  6 months

• Munich Chronotype Questionnaire

  6 months

• Fagerström Test for Nicotine Dependence

  6 months

• 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

  6 months

• Insomnia Severity Index

  6 months

Other Outcomes (17)

• Duke- The University of North Carolina at Chapel Hill (UNC) Functional Social Support Questionnaire (FSSQ)

  6 months

• Patient Health Questionnaire (PHQ-9)

  6 months

• Generalized Anxiety Disorder (GAD-7)

  6 months

Study Arms (2)

Sleep Restriction

EXPERIMENTAL

4 hours time in bed (1 am to 5 am)

Behavioral: Sleep restriction condition

Sleep Extension

EXPERIMENTAL

10 hours time in bed (10 pm to 8 am)

Behavioral: Sleep extension condition

Interventions

Sleep restriction condition BEHAVIORAL

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 Restriction

Sleep extension condition BEHAVIORAL

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.

Sleep Extension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Lives in restricted environment that does not allow smoking
• Pregnant or lactating
• 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
• 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
• Non-English speaking
• Lives in restricted environment that does not allow smoking
• Pregnant or lactating

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Oklahoma: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Alabama, Birmingham

Birmingham, Alabama, 35226, United States

Location

MeSH Terms

Conditions

Smoking; Parasomnias; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Karen L Cropsey, Psy.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: January 1, 2021
• Primary Completion: April 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)