N/A
N=19
Smoking Cessation for Smokers With Sleep Problems
Nicotine Dependence · Cigarette Smoking · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01277887 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Smoking Abstinence — 1; 2; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-Behavioral Counseling (Behavioral); Smoking Cessation Counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence |
1; 2; 1; 0 | — |
| SECONDARY Self-Control to Resist Smoking Cues |
— | — |
| SECONDARY Sleep Efficiency |
85.10; 72.51; 92.17; 77.56 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01277887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.