Smoking Cessation for Smokers With Sleep Problems - Full Text View

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.

Condition	Intervention	Phase
Nicotine Dependence Cigarette Smoking Insomnia	Behavioral: Cognitive-Behavioral Counseling Behavioral: Smoking Cessation Counseling	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Smoking Cessation for Smokers With Sleep Problems

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Sleep Disorders Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Smoking Abstinence [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
To develop effect size estimates for smoking cessation defined as point prevalence smoking abstinence over the last 7 days of treatment and follow-up (i.e., 4 weeks post-treatment) comparing smokers in the two counseling conditions.

Secondary Outcome Measures:

Self-Control to Resist Smoking Cues [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
To develop an effect size estimate for changes in diary measures of sleep efficiency over the entire treatment period comparing smokers in the two counseling conditions.

Estimated Enrollment:	30
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Behavioral: Cognitive-Behavioral Counseling 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. Other Name: CBT-I + SC
Placebo Comparator: 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.	Behavioral: Smoking Cessation Counseling The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program. Other Name: SC

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277887

Locations

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Lisa Fucito, PhD

Yale University

More Information

No publications provided

Responsible Party:	Lisa M. Fucito, Assistant Professor, Yale University
ClinicalTrials.gov Identifier:	NCT01277887 History of Changes
Other Study ID Numbers:	NCT009241, P50DA009241-16
Study First Received:	January 13, 2011
Last Updated:	October 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Smoking
Nicotine
Nicotine polacrilex
Nicotine replacement

Additional relevant MeSH terms:

Smoking
Tobacco Use Disorder
Dyssomnias
Sleep Disorders
Parasomnias
Substance-Related Disorders

Mental Disorders
Habits
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013