Examination of Sleep, Smoking Cessation, and Cardiovascular Health

The current study is a randomized controlled trial designed to test the impact and efficacy of a sleep advancement counseling (SAC) protocol in response to standard nicotine dependence treatment (behavioral counseling + varenicline) in a sample of 90 treatment seeking smokers from the greater Newark city/Newcastle county area. Following eligibility assessment, which include an overnight polysomnography (sleep study), 90 eligible and consenting treatment-seeking smokers will be randomized to either the experimental smoking cessation + SAC (N=60), or the control, smoking cessation + general health education (GHE) alone (N=30) condition. Participants will complete six in-person counseling sessions over a 15-week treatment period (wks 1, 3, 4,7,11,15) As part of the smoking cessation treatment protocol, eligible participants will receive 12 weeks of FDA-approved smoking cessation medication, Varenicline, during week 3-15. An end of treatment (week 15) and a 12-week follow-up (week 27) assessment will be conducted in-person to allow for the objective assessment of smoking status and cardiovascular markers.

Inclusion criteria

• adults (>18 -65) who smoke at least 8 cigarettes/day;
• Report wanting to quit smoking in the next month
• No current diagnosis of psychosis or bipolar disorder.
• able to communicate in English and provide written informed consent for study procedures
• able to use varenicline safely.
• No current diagnosis of any sleep disorders (except of insomnia)
• Have access to a smart phone or tablet own the home

Exclusion criteria

• Current enrollment or plans to enroll in another smoking cessation program and/or use a nicotine substitute (e.g., e-cigarettes) in the next 6 months,
• Current use of illicit drugs (e.g., cocaine, opioids, or methamphetamines),
• Current alcohol consumption that exceeds 14 standard alcoholic drinks/week for men, and more than 7 for women.
• Current use or recent discontinuation (within last 14 days) of anti-psychotic and/or bipolar disorder medications,
• Women who are pregnant, planning a pregnancy within the next 6 months, or lactating,
• Uncontrolled hypertension (SBP >160 or DBP >100)
• Current sleep disorder or use of sleep medication
• History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval),
• Any current suicidal ideation, or self-reported suicide attempt
• Current or past diagnosis of psychotic or bipolar disorder
• Currently working night/rotating shift.
• Allergy to Varenicline
• Unstable or untreated moderate or severe depression as assessed by the center for epidemiology studies depression scale 16 for higher.