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Smoking Cessation for Smokers With Sleep Problems

Primary Purpose

Nicotine Dependence, Cigarette Smoking, Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive-Behavioral Counseling

Smoking Cessation Counseling

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking, Nicotine, Nicotine polacrilex, Nicotine replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cognitive-Behavioral Counseling

Smoking Cessation Counseling

Arm Description

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01277887

First Posted

January 13, 2011

Last Updated

December 20, 2017

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01277887

Brief Title

Smoking Cessation for Smokers With Sleep Problems

Official Title

Smoking Cessation for Smokers With Sleep Problems

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence, Cigarette Smoking, Insomnia

Keywords

Smoking, Nicotine, Nicotine polacrilex, Nicotine replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-Behavioral Counseling

Arm Type

Active Comparator

Arm Description

Arm Title

Smoking Cessation Counseling

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive-Behavioral Counseling

Other Intervention Name(s)

CBT-I + SC

Intervention Description

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

Intervention Name(s)

Smoking Cessation Counseling

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Smoking Abstinence

Description

Time Frame

1 Week

Secondary Outcome Measure Information:

Title

Self-Control to Resist Smoking Cues

Description

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.

Time Frame

4 Weeks

Title

Sleep Efficiency

Description

Time Frame

Change from Baseline at 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Fucito, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

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Smoking Cessation for Smokers With Sleep Problems

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