Cigarette Smoking, Insomnia, Nicotine Dependence
Conditions
Keywords
Smoking, Nicotine, Nicotine polacrilex, Nicotine replacement
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.
Interventions
BEHAVIORALCognitive-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.
BEHAVIORALSmoking 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 1 Week | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Control to Resist Smoking Cues | 4 Weeks | 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 | Change from Baseline at 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Randomized between 9/2/11-12/6/11 at an outpatient research clinic.
Pre-assignment details
Prior to randomization, inclusion and exclusion criteria were assessed. Reasons for exclusion included CBT-I contraindicated medical/psychiatric conditions, not meeting smoking criteria, other drug dependence, and not meeting sleep criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| 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.
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. | 10 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Post-Quit Treatment Phase | No longer interested in treatment | 3 | 5 |
| Pre-Quit Treatment Phase | No longer interested in treatment | 1 | 0 |
| Pre-Quit Treatment Phase | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Smoking Cessation Counseling | Cognitive-Behavioral Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Continuous | 51.20 years STANDARD_DEVIATION 10.73 | 51.86 years STANDARD_DEVIATION 15.07 | 51.47 years STANDARD_DEVIATION 12.25 |
| Region of Enrollment United States | 10 participants | 7 participants | 17 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 10 |
| other Total, other adverse events | 6 / 7 | 10 / 10 |
| serious Total, serious adverse events | 0 / 7 | 0 / 10 |
Outcome results
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.
Time frame: 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cognitive-Behavioral Counseling | Smoking Abstinence | 7-day PPA at end of treatment | 1 participants |
| Cognitive-Behavioral Counseling | Smoking Abstinence | 7-day PPA at follow up | 1 participants |
| Smoking Cessation Counseling | Smoking Abstinence | 7-day PPA at follow up | 0 participants |
| Smoking Cessation Counseling | Smoking Abstinence | 7-day PPA at end of treatment | 2 participants |
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.
Time frame: 4 Weeks
Population: These data were not collected.
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.
Time frame: Change from Baseline at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-Behavioral Counseling | Sleep Efficiency | Week 4 | 92.17 percentage of time asleep in bed | Standard Deviation 11.9 |
| Cognitive-Behavioral Counseling | Sleep Efficiency | Baseline | 85.10 percentage of time asleep in bed | Standard Deviation 13.08 |
| Smoking Cessation Counseling | Sleep Efficiency | Baseline | 72.51 percentage of time asleep in bed | Standard Deviation 15.43 |
| Smoking Cessation Counseling | Sleep Efficiency | Week 4 | 77.56 percentage of time asleep in bed | Standard Deviation 18.11 |