Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Nicotine Dependence
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking, Smoking cessation, Nicotine
Eligibility Criteria
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.
Sites / Locations
- University of Delaware
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sleep Advancement Counseling
General Health Intervention
Participants will receive a 15-week intervention targeting smoking cessation and sleep counseling intervention. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. Sleep counseling components in the form of CBT for insomnia will be given as part of the smoking cessation counseling.
Participants will receive a 15-week intervention targeting smoking cessation and general health information. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. The general health information counseling will be given as part of the smoking cessation counseling and topics include diet, physical activity, oral health, cancer screening and skin protection.