Trial Outcomes & Findings for Smoking Cessation for Smokers With Sleep Problems (NCT NCT01277887)
NCT ID: NCT01277887
Last Updated: 2017-12-21
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
1 Week
Results posted on
2017-12-21
Participant Flow
Randomized between 9/2/11-12/6/11 at an outpatient research clinic.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Pre-Quit Treatment Phase
STARTED
|
9
|
10
|
|
Pre-Quit Treatment Phase
Entered Study
|
7
|
10
|
|
Pre-Quit Treatment Phase
COMPLETED
|
6
|
10
|
|
Pre-Quit Treatment Phase
NOT COMPLETED
|
3
|
0
|
|
Post-Quit Treatment Phase
STARTED
|
6
|
10
|
|
Post-Quit Treatment Phase
COMPLETED
|
3
|
5
|
|
Post-Quit Treatment Phase
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Pre-Quit Treatment Phase
No longer interested in treatment
|
1
|
0
|
|
Pre-Quit Treatment Phase
Withdrawal by Subject
|
2
|
0
|
|
Post-Quit Treatment Phase
No longer interested in treatment
|
3
|
5
|
Baseline Characteristics
Smoking Cessation for Smokers With Sleep Problems
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioral Counseling
n=7 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.
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
n=10 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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.86 years
STANDARD_DEVIATION 15.07 • n=5 Participants
|
51.20 years
STANDARD_DEVIATION 10.73 • n=7 Participants
|
51.47 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 WeekSmoking 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."
Outcome measures
| Measure |
Cognitive-Behavioral Counseling
n=7 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.
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
n=10 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.
|
|---|---|---|
|
Smoking Abstinence
7-day PPA at end of treatment
|
1 participants
|
2 participants
|
|
Smoking Abstinence
7-day PPA at follow up
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: These data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline at 4 weeksSelf-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.
Outcome measures
| Measure |
Cognitive-Behavioral Counseling
n=7 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.
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
n=10 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.
|
|---|---|---|
|
Sleep Efficiency
Baseline
|
85.10 percentage of time asleep in bed
Standard Deviation 13.08
|
72.51 percentage of time asleep in bed
Standard Deviation 15.43
|
|
Sleep Efficiency
Week 4
|
92.17 percentage of time asleep in bed
Standard Deviation 11.90
|
77.56 percentage of time asleep in bed
Standard Deviation 18.11
|
Adverse Events
Cognitive-Behavioral Counseling
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Smoking Cessation Counseling
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive-Behavioral Counseling
n=7 participants at risk
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.
|
Smoking Cessation Counseling
n=10 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7
|
20.0%
2/10
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
|
10.0%
1/10
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7
|
20.0%
2/10
|
|
General disorders
Decreased Appetite
|
14.3%
1/7
|
30.0%
3/10
|
|
General disorders
Increased Appetite
|
28.6%
2/7
|
50.0%
5/10
|
|
General disorders
Headache
|
28.6%
2/7
|
10.0%
1/10
|
|
General disorders
Dizziness
|
0.00%
0/7
|
20.0%
2/10
|
|
Vascular disorders
Rapid Heartbeat
|
0.00%
0/7
|
30.0%
3/10
|
|
General disorders
Fatigue
|
28.6%
2/7
|
0.00%
0/10
|
|
Psychiatric disorders
Nervousness/Anxiety
|
14.3%
1/7
|
20.0%
2/10
|
|
General disorders
Insomnia
|
28.6%
2/7
|
0.00%
0/10
|
|
General disorders
Extreme Sleepiness
|
28.6%
2/7
|
20.0%
2/10
|
|
Psychiatric disorders
Depression
|
14.3%
1/7
|
30.0%
3/10
|
|
Skin and subcutaneous tissue disorders
Itching
|
14.3%
1/7
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
2/7
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/7
|
10.0%
1/10
|
|
General disorders
Vivid Dreams
|
28.6%
2/7
|
40.0%
4/10
|
|
Skin and subcutaneous tissue disorders
Sweating
|
14.3%
1/7
|
20.0%
2/10
|
|
Gastrointestinal disorders
Bowel Changes- Increased Frequency
|
14.3%
1/7
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
10.0%
1/10
|
|
General disorders
Other
|
85.7%
6/7
|
100.0%
10/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place