Smoking Cessation for Smokers With Sleep Problems


Cigarette Smoking | Insomnia | Nicotine Dependence

Trial Phase

Phase 0

Trial Purpose and Description

Trial Purpose

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.

Trial 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.

Participation Guidelines

18 Years - 75 Years

Eligibility Criteria

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

- 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

- 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
National Institute on Drug Abuse (NIDA)
Yale University
December 2010
Last Updated:
June 12, 2014
Study HIC#:
1005006857 ID: NCT01277887