Smoking Cessation for Smokers With Sleep Problems

NCT01277887 | Completed Results DMC

• 2 other identifiers: 1005006857P50DA009241-16
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Cigarette Smoking; Insomnia

Keywords

Smoking; Nicotine; Nicotine polacrilex; Nicotine replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Self-Control to Resist Smoking Cues

  4 Weeks

• Sleep Efficiency

  Change from Baseline at 4 weeks

Study Arms (2)

Cognitive-Behavioral Counseling

ACTIVE COMPARATOR

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

Smoking Cessation Counseling

PLACEBO COMPARATOR

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

Interventions

Cognitive-Behavioral Counseling 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.

Also known as: CBT-I + SC

Cognitive-Behavioral Counseling

Smoking Cessation Counseling 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.

Also known as: SC

Smoking Cessation Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Sleep Initiation and Maintenance Disorders; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Behavior; Tobacco Use; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Lisa Fucito, PhD
• Organization: Yale University School of Medicine

lisa.fucito@yale.edu

203 974-5759

Study Officials

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 21, 2017
• Results First Posted: December 21, 2017

Record last verified: 2017-12

Locations

US (1)