Smoking Cessation for Smokers With Sleep Problems

Not Applicable

Completed

• Conditions: Cigarette Smoking; Nicotine Dependence; Insomnia
• Interventions: Behavioral: Smoking Cessation Counseling; Behavioral: Cognitive-Behavioral Counseling

• Registration Number: NCT01277887
• Lead Sponsor: Yale University

Brief Summary

This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation. The study is designed to find out whether one of these counseling interventions is more effective for smoking cessation among individuals with sleep problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and 3) a 1-month follow-up.

Detailed Description

This is a developmental study to: 1) create and test an integrated cognitive-behavioral smoking cessation and insomnia intervention with 30 smokers who report current insomnia. Participants are randomized to 1 of 2 counseling conditions. The cognitive-behavioral intervention provides standard care smoking counseling along with counseling to address insomnia. The smoking counseling intervention provides standard care smoking counseling adapted from the American Lung Association Freedom from Smoking program. Efficacy data from this trial will be used to determine effect size estimates for biologically confirmed self-reported point prevalence smoking abstinence at the end of treatment and 1 month after completing treatment. Changes in sleep efficiency and self-control to resist smoking urges will also be examined. If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale large study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2017-04-21
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Results First Posted: 2017-12-21
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Between the ages of 18 and 75.
• Smoking 10 or more cigarettes per day for at least 1 year.
• An expired air breath carbon monoxide level > 10 ppm.
• Motivated to stop smoking.
• Understand English.
• Meet DSM-IV criteria for insomnia.
• Report sleep latency or waking after sleep onset >30 minutes on ≥6 occasions within past month.

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Exclusion Criteria

• History of allergic reactions to adhesives.
• Unstable psychiatric/medical conditions such as current suicidal or homicidal ideation, acute psychosis, dementia.
• Have a current diagnosis of DSM-IV alcohol or drug dependence other than nicotine.
• Use of tobacco products other than cigarettes or use of marijuana.
• Intention to use nicotine replacement therapy, varenicline, or bupropion during study participation.
• Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
• New onset of psychiatric disorders or new psychotropic medications within the past 3 months.
• Inability to read/understand English.
• History of sleep apnea based on responses to Berlin Questionnaire.
• History of restless leg syndrome.
• Current night or rotating shift work.
• Proposed travel across 2 or more time zones during study participation.
• Medical/psychiatric conditions contraindicated for sleep restriction (i.e., seizure disorders, severe excessive daytime sleepiness - Epworth Scale >18, and bipolar disorder).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking Cessation Counseling	Smoking Cessation Counseling	The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.
Cognitive-Behavioral Counseling	Cognitive-Behavioral Counseling	The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	1 Week	Smoking abstinence is operationally defined as "no smoking on the last 7 days of the last week of treatment. And no smoking within the last 7 days at the first follow-up visit 4 weeks after completing treatment."

Secondary Outcome Measures

Name	Time	Method
Self-Control to Resist Smoking Cues	4 Weeks	To develop an effect size estimate for changes in self-control to resist smoking cues from baseline to the day before quitting smoking comparing smokers in the two counseling conditions.
Sleep Efficiency	Change from Baseline at 4 weeks	Self-reported sleep efficiency subscale of the Pittsburgh Sleep Quality Index. This is calculated as the percentage of total time spent asleep in a night compared to the total time spent in bed, multiplied by 100.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States