Smoking Cessation for Smokers With Sleep Problems

Study Overview
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Brief Summary
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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
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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.

Official Title
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Smoking Cessation for Smokers With Sleep Problems

Conditions
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Nicotine Dependence, Cigarette Smoking, Insomnia

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Counseling
* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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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. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive-Behavioral Counseling<br>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. | Behavioral: Cognitive-Behavioral Counseling<br>* The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia.<br>* Other names: CBT-I + SC;|
| Placebo Comparator: Smoking Cessation Counseling<br>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. | Behavioral: Smoking Cessation Counseling<br>* The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.<br>* Other names: SC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | 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. | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Control to Resist Smoking Cues | 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. | 4 Weeks | 
| Sleep Efficiency | 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. | Change from Baseline at 4 weeks | 

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