Smoking Cessation for Smokers With Sleep Problems

NCT ID: NCT01277887

Last Updated: 2017-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-03-31

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.

Conditions

Nicotine Dependence; Cigarette Smoking; Insomnia

Keywords

Smoking; Nicotine; Nicotine polacrilex; Nicotine replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioral Counseling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Smoking Cessation Counseling

Intervention Type: BEHAVIORAL

The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I + SC; SC

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Fucito, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

P50DA009241-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1005006857

Identifier Type: -

Identifier Source: org_study_id