Clinical trial NCT02663882: Self-Control and Adult Cigarette Smokers
Official title: Self-Control and Adult Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
self control
Lead sponsor: Yeshiva University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Baseline, one week followup after baseline
Secondary outcomes:
measure: Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up
timeFrame: 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)
measure: Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up
timeFrame: Baseline, follow up appointment one week after baseline
measure: Change in Expired Breath Carbon Monoxide Level
timeFrame: Baseline, follow up one week after baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Smoking and Nicotine Dependence Research Laboratory
state: New York
Study officials:
affiliation: Yeshiva University
name: Andrea H Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: