Smoking
Conditions
Keywords
smoking, self control
Brief summary
The purpose of this study is to learn more about self-control and adults who smoke cigarettes. It has been suggested that people can improve self-control by practicing tasks that require the use of self-control (such as delaying cigarettes or sitting up as straight as possible). The goal of this study is to learn about whether scores on self-control and other measures will change after one week of practicing self-control tasks at home. We believe that adults who smoke cigarettes will show better self-control after practicing tasks for a week.
Detailed description
The purpose of this pilot study is to examine a smoking-related self-control task and smoking behavior in adult smokers who are not motivated to quit smoking. This pilot study will have a between-subjects design. All participants will be asked to complete two study appointments. First, they will complete a baseline appointment where they will review consent procedures. Participants who complete the consent forms will then be asked to fill out measures of demographics, smoking, and self-control. Smoking will be confirmed using expired breath carbon monoxide (CO) levels taken using a CO monitor. At that appointment participants will be randomly assigned to complete one of two self-control tasks: a task that is related to smoking (e.g., giving instructions to delay smoking when they have a craving) or a task that is not related to smoking (e.g., participants will be instructed to try to maintain the best posture possible (e.g., sit up straight, walk with good posture) as much as possible throughout each day Random assignment will be done using a random number generator and 50% of participants will be assigned to the smoking task while the other 50% will be assigned to the non-smoking task. Study staff will received standardized instructions to read to each participant about the task that they are assigned to practice during the week. Participants will be asked to practice their assigned self-control task every day for a week and to complete a brief series of questions about the effort and time spent practicing the task that day along with the number of cigarettes they smoked that day. After one week, participants will return for the second study appointment where they will report on their effort and time spent practicing the self-control tasks and complete additional measures of smoking and self-control.
Interventions
BEHAVIORALself control practice - smoking related task
participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day
BEHAVIORALself control practice - non-smoking related task
participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Sponsors
Yeshiva University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be adults who are 18 years of age or older 2. Currently smoke ≥10 cigarettes per day biochemically confirmed by an expired breath carbon monoxide (CO) level ≥8 3. Report that they are not currently attempting to quit smoking and not currently receiving smoking cessation treatment (e.g., counseling, nicotine replacement therapy, bupropion, varenicline) 4. Have the capacity to give informed consent 5. Be English-speaking.
Exclusion criteria
1. Children under the age of 18 2. Non-English speakers 3. Those who do not have the capacity to consent will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) | Baseline, one week followup after baseline | Participants were instructed to squeeze a hand-grip exerciser as long as possible and research staff used a stopwatch to time the length of time that the hand-grip is squeezed. A wad of paper was inserted between the handles of the hand-grip and timing stopped when the paper fell from the hand-grip indicating that the participant had released the hand-grip. The hand-grip was held before and after a thought suppression exercise that was meant to diminish self-control in order to control for individual hand strength. Self-control was measured as the difference in the length of time holding the hand-grip before and after the thought suppression exercise at each appointment (baseline and one week followup). Change in self-control due to task practice was measured as \[self-control at the second study appointment one week after the first appointment\] minus \[self-control at the first study appointment\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up | 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline) | Self-control was measured using the investigator-developed Overall Self Control question (1 item): Participants were asked: How would you rate your overall level of self-control on a scale from 0 (I have no self-control) to 10 (I have complete self-control)? The response scale was a 10-point Likert scale ranging from 0 (I have no self-control) to 10 (I have complete self control). Higher scores indicated higher self control. |
| Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up | Baseline, follow up appointment one week after baseline | Change in self-reported average number of cigarettes smoked per day from study appointment 1 (baseline) to study appointment 2 (one week later). There is no official title to this item (cigarettes per day). Participants were asked to respond to this investigator-written question: How many cigarettes each day do you smoke right now? The response scale was open (I smoke \_\_\_\_\_\_\_\_ cigarettes each day that I smoke) so that participants could write in any number of cigarettes. At baseline, there was no official minimum value but participants had to report smoking 10 cigarettes a day as part of the inclusion criteria for the study. There was no maximum response option provided. For the followup assessment (one week after baseline), participants were asked the same questions and there was no minimum or maximum response options provided. Higher numbers indicate a greater number of cigarettes smoked each day |
| Change in Expired Breath Carbon Monoxide Level | Baseline, follow up one week after baseline | Change in a biochemical measure of smoking (expired breath carbon monoxide level) from study appointment 1 (baseline) to study appointment 2 (one week later) This measure is not a scale. Participants provide a breath sample into a carbon monoxide monitor and the monitor provides a number from 0 and up in ppm (parts per million). Higher numbers indicate greater levels of carbon monoxide and this level is used as a proxy for amount of recent smoking (higher numbers indicating greater recent smoking). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Smoking-related Self Control Task self control practice - smoking related task
self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day | 39 |
| Non-smoking-related Self Control Task self control practice - non-smoking related task
self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day | 36 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
Baseline characteristics
| Characteristic | Smoking-related Self Control Task | Total | Non-smoking-related Self Control Task |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 10.1 | 44.8 years STANDARD_DEVIATION 10.8 | 46.8 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 19 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 56 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 48 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment United States | 39 Participants | 75 Participants | 36 Participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 8 Participants |
| Sex: Female, Male Male | 28 Participants | 56 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 36 |
| other Total, other adverse events | 0 / 39 | 0 / 36 |
| serious Total, serious adverse events | 0 / 39 | 0 / 36 |
Outcome results
Primary
Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline)
Participants were instructed to squeeze a hand-grip exerciser as long as possible and research staff used a stopwatch to time the length of time that the hand-grip is squeezed. A wad of paper was inserted between the handles of the hand-grip and timing stopped when the paper fell from the hand-grip indicating that the participant had released the hand-grip. The hand-grip was held before and after a thought suppression exercise that was meant to diminish self-control in order to control for individual hand strength. Self-control was measured as the difference in the length of time holding the hand-grip before and after the thought suppression exercise at each appointment (baseline and one week followup). Change in self-control due to task practice was measured as \[self-control at the second study appointment one week after the first appointment\] minus \[self-control at the first study appointment\].
Time frame: Baseline, one week followup after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smoking-related Self Control Task | Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) | data from baseline appointment | -9.36 seconds | Standard Deviation 103.42 |
| Smoking-related Self Control Task | Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) | data from second appointment, one week after baseline | -4.32 seconds | Standard Deviation 109.14 |
| Non-smoking-related Self Control Task | Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) | data from baseline appointment | 2.76 seconds | Standard Deviation 80.82 |
| Non-smoking-related Self Control Task | Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) | data from second appointment, one week after baseline | 42.88 seconds | Standard Deviation 179.95 |
Comparison: The non-smoking-related self control task was the comparison group in relation to the smoking-related self control taskp-value: 0.503ANOVA
Secondary
Change in Expired Breath Carbon Monoxide Level
Change in a biochemical measure of smoking (expired breath carbon monoxide level) from study appointment 1 (baseline) to study appointment 2 (one week later) This measure is not a scale. Participants provide a breath sample into a carbon monoxide monitor and the monitor provides a number from 0 and up in ppm (parts per million). Higher numbers indicate greater levels of carbon monoxide and this level is used as a proxy for amount of recent smoking (higher numbers indicating greater recent smoking).
Time frame: Baseline, follow up one week after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smoking-related Self Control Task | Change in Expired Breath Carbon Monoxide Level | baseline | 18.4 ppm (parts per million) | Standard Deviation 6.4 |
| Smoking-related Self Control Task | Change in Expired Breath Carbon Monoxide Level | followup (one week after baseline) | 16.8 ppm (parts per million) | Standard Deviation 10.4 |
| Non-smoking-related Self Control Task | Change in Expired Breath Carbon Monoxide Level | baseline | 16.6 ppm (parts per million) | Standard Deviation 6.6 |
| Non-smoking-related Self Control Task | Change in Expired Breath Carbon Monoxide Level | followup (one week after baseline) | 16.8 ppm (parts per million) | Standard Deviation 5.5 |
Comparison: The non-smoking-related self control task was the comparison group in relation to the smoking-related self control taskp-value: 0.302ANOVA
Secondary
Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up
Change in self-reported average number of cigarettes smoked per day from study appointment 1 (baseline) to study appointment 2 (one week later). There is no official title to this item (cigarettes per day). Participants were asked to respond to this investigator-written question: How many cigarettes each day do you smoke right now? The response scale was open (I smoke \_\_\_\_\_\_\_\_ cigarettes each day that I smoke) so that participants could write in any number of cigarettes. At baseline, there was no official minimum value but participants had to report smoking 10 cigarettes a day as part of the inclusion criteria for the study. There was no maximum response option provided. For the followup assessment (one week after baseline), participants were asked the same questions and there was no minimum or maximum response options provided. Higher numbers indicate a greater number of cigarettes smoked each day
Time frame: Baseline, follow up appointment one week after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smoking-related Self Control Task | Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up | baseline | 13.1 cigarettes per day | Standard Deviation 4.1 |
| Smoking-related Self Control Task | Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up | followup appointment one week after baseline | 12.0 cigarettes per day | Standard Deviation 5.7 |
| Non-smoking-related Self Control Task | Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up | baseline | 12.0 cigarettes per day | Standard Deviation 5.7 |
| Non-smoking-related Self Control Task | Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up | followup appointment one week after baseline | 13.2 cigarettes per day | Standard Deviation 4.3 |
Comparison: The non-smoking-related self control task was the comparison group in relation to the smoking-related self control taskp-value: 0.717ANOVA
Secondary
Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up
Self-control was measured using the investigator-developed Overall Self Control question (1 item): Participants were asked: How would you rate your overall level of self-control on a scale from 0 (I have no self-control) to 10 (I have complete self-control)? The response scale was a 10-point Likert scale ranging from 0 (I have no self-control) to 10 (I have complete self control). Higher scores indicated higher self control.
Time frame: 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smoking-related Self Control Task | Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up | baseline | 6.1 score on a scale | Standard Deviation 2.4 |
| Smoking-related Self Control Task | Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up | followup | 6.5 score on a scale | Standard Deviation 2.1 |
| Non-smoking-related Self Control Task | Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up | baseline | 6.3 score on a scale | Standard Deviation 4.5 |
| Non-smoking-related Self Control Task | Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up | followup | 6.9 score on a scale | Standard Deviation 5.2 |
Comparison: The non-smoking-related self control task was the comparison group in relation to the smoking-related self control taskp-value: 0.765ANOVA