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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009241-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sleep Efficiency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Fucito, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
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.
Randomized between 9/2/11-12/6/11 at an outpatient research clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Quit Treatment Phase |
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| Post-Quit Treatment Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Number | participants | 1 Week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fucito, PhD | Yale University School of Medicine | 203 974-5759 | lisa.fucito@yale.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
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| 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. |
|
|
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 |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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. |
|
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| 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. | These data were not collected. | Posted | 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. | Posted | Mean | Standard Deviation | percentage of time asleep in bed | Change from Baseline at 4 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 10 | 10 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Decreased Appetite | General disorders | Non-systematic Assessment |
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| Increased Appetite | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Rapid Heartbeat | Vascular disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Nervousness/Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Extreme Sleepiness | General disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders |
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| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Muscle Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Vivid Dreams | General disorders | Non-systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Bowel Changes- Increased Frequency | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| D001519 | Behavior |
| D064424 | Tobacco Use |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |