SmokingNCT02663882
Self-Control and Adult Cigarette Smokers
A study of Smoking, run by Yeshiva University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be adults who are 18 years of age or older
- Currently smoke ≥10 cigarettes per day biochemically confirmed by an expired breath carbon monoxide (CO) level ≥8
- 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)
- Have the capacity to give informed consent
- Be English-speaking.
Who cannot join
- Children under the age of 18
- Non-English speakers
- Those who do not have the capacity to consent will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Smoking and Nicotine Dependence Research Laboratory
The Bronx, New York, 10461
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- self control practice - smoking related task, self control practice - non-smoking related task
- Keywords
- smoking, self control
- Medical subject headings
- Smoking, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self control practice - smoking related taskBehavioural
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
self control practice - non-smoking related taskBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| smoking-related self control task | Experimental | self control practice - smoking related task Receives: Behavioral: self control practice - smoking related task |
| Non-smoking-related self control task | Active comparator | self control practice - non-smoking related task Receives: Behavioral: self control practice - non-smoking related task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Baseline, one week followup after baseline
Secondary outcomes (3)
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.
Measured: 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)
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
Measured: Baseline, follow up appointment one week after baseline
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).
Measured: Baseline, follow up one week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeshiva University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Weinberger, Yeshiva University
- Investigators
- Andrea H Weinberger, PhD, Principal investigator, Yeshiva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663882
- Sponsor's protocol ID
- 2015-5479
- Status last verified
- Nov 2020
- First submitted
- 19 Jan 2016
- Last updated
- 14 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Control and Adult Cigarette Smokers
- ClinicalTrials.gov ID
- NCT02663882
- Acronym / sponsor ID
- 2015-5479
- Conditions
- Smoking
- Keywords
- smoking, self control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Yeshiva UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smoking-related self control task | Experimental | Behavioral: self control practice - smoking related taskself control practice - smoking related task |
| Non-smoking-related self control task | Active comparator | Behavioral: self control practice - non-smoking related taskself control practice - non-smoking related task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be adults who are 18 years of age or older
- Currently smoke ≥10 cigarettes per day biochemically confirmed by an expired breath carbon monoxide (CO) level ≥8
- 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)
- Have the capacity to give informed consent
- Be English-speaking.
Key exclusion criteria (3 listed)
- Children under the age of 18
- Non-English speakers
- Those who do not have the capacity to consent will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self control practice - smoking related taskparticipants 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 | Behavioural | smoking-related self control task |
| self control practice - non-smoking related taskparticipants 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 | Behavioural | Non-smoking-related self control task |
Primary outcome
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)
Time frame: 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].
3 secondary outcomes
Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up
Time frame: 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)
Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up
Time frame: Baseline, follow up appointment one week after baseline
Change in Expired Breath Carbon Monoxide Level
Time frame: Baseline, follow up one week after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea H Weinberger, PhD principal investigator
Yeshiva University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Smoking, run by Yeshiva University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline, one week followup after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.