Examination of Sleep, Smoking Cessation, and Cardiovascular Health

Completed · Phase 3

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT02941718

Run by

University of Delaware

People needed

30

Starts

2016-11-01

Expected to finish

2019-01-17

Last updated by the study team

2019-08-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Delaware — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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