Examination of Sleep, Smoking Cessation, and Cardiovascular Health

Study Overview
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Brief Summary
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Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This study will address this conceptual and empirical gap by conducting a 15-week proof-of-concept study to determine whether standard smoking cessation treatment can be optimized with a multi-metric sleep advancement counseling intervention.

Detailed Description
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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.

Official Title
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Examination of Sleep, Smoking Cessation, and Cardiovascular Health

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Sleep Advancement Counseling
* Behavioral: General Health Information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Advancement Counseling<br>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. | Behavioral: Sleep Advancement Counseling<br>* Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.<br>|
| Active Comparator: General Health Intervention<br>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. | Behavioral: General Health Information<br>* Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Monoxide Level | % of participants with a CO level of 10 or fewer parts per million (ppm) | 15-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Sleep Duration and Timing | Will be measured using a motion-logger accelerometer device. Participants will wear the lotion logger watches on their non-dominant wrist at key points during the study (weeks 1, 4, 15). Data will be collected at 1min epochs. | 15-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking cessation, Nicotine