Smoking Cessation for Smokers With Sleep Problems

Insomnia Clinical Trial

Official title:

Smoking Cessation for Smokers With Sleep Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277887
• Other study ID #: 1005006857
• Secondary ID: P50DA009241-16
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: December 20, 2017
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cigarette Smoking
• Dyssomnias
• Insomnia
• Nicotine Dependence
• Parasomnias
• Sleep Wake Disorders
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	1 Week
Secondary	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.	4 Weeks
Secondary	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.	Change from Baseline at 4 weeks