NCT02941718

Examination of Sleep, Smoking Cessation, and Cardiovascular Health

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Advancement Counseling	Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.
BEHAVIORAL	General Health Information	Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2016-10-21
• Last updated: 2019-08-30

Locations

1 site across 1 country: United States