Clinical trial NCT01277887: Smoking Cessation for Smokers With Sleep Problems
Official title: Smoking Cessation for Smokers With Sleep Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Cigarette Smoking
Insomnia
Keywords: Smoking
Nicotine
Nicotine polacrilex
Nicotine replacement
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 1 Week
Secondary outcomes:
measure: Self-Control to Resist Smoking Cues
timeFrame: 4 Weeks
measure: Sleep Efficiency
timeFrame: Change from Baseline at 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Lisa Fucito, PhD
role: PRINCIPAL_INVESTIGATOR
References: