Nicotine Dependence, Smoking, Smoking Cessation
Conditions
Keywords
Smoking Cessation, Smoking, Nicotine
Brief summary
The objective of this research is to determine whether smartphone games show promise for helping smokers increase their chances of quitting. The central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.
Interventions
DRUGNicotine patch
4-week starter kit of nicotine patch
BEHAVIORALCessation Counseling
5 brief counseling sessions
DEVICEMobile Games
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being age 18 or older; * being able to read and write English; * being willing and able to learn how to use a smartphone if they have not used one before; * smoking 10 or more cigarettes per day for the past 6 months; * having an expired carbon monoxide rating of 6 ppm or greater; * not having been diagnosed with or treated for schizophrenia, psychosis or bipolar disorder in the past 10 years; * being willing to make a quit attempt in 2 weeks; * agreeing to attend clinic visits, receive coaching calls, and complete brief smartphone assessments; * planning to remain in the area for at least the next 2 months; * using the following alternative tobacco products (a pipe, full sized cigars, snuff or chew) no more than two times a week over the past month; * being willing to stop using electronic cigarettes (e-cigarettes) for the 6 weeks they are in the study; * not currently taking bupropion, Wellbutrin, or Zyban; * if currently using nicotine replacement therapy or Varenicline, agreeing to use only study medication for the duration of the study; * being willing and able to use the nicotine patch; * never having had a serious skin reaction or other allergic reaction to the nicotine patch; * not pregnant, trying to conceive, or nursing; * if a woman of childbearing potential, agreeing to use or having their partner use an acceptable method of birth control during a 2 month period (1 month of nicotine patch and 1 month after). (Acceptable methods of birth control include: abstinence, condoms, diaphragm, birth control pills or injectable contraceptive \[e.g., Depo-Provera\], an intrauterine device, hysterectomy, tubal ligation, sterilization, vasectomy, or being more than 2 years post-menopausal.) * Participants need to report playing video games for no more than 60 minutes a day. * Although participants can play console games, they need to be willing to not play any mobile games for 6 weeks during the study if they are asked to do so. * Participants need to report being willing to stay in the study even if they are not at first successful in quitting smoking. * They need to report that they have a way to get to the clinic.
Exclusion criteria
* They will be excluded if in the last 4 weeks they have been hospitalized for any of the following: a stroke, heart attack, congestive heart failure, or an abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change | Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline | Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile Games This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games | 16 |
| No Mobile Games This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Mobile Games | Total | No Mobile Games |
|---|---|---|---|
| Age, Continuous | 38.06 years STANDARD_DEVIATION 10.27 | 40.73 years STANDARD_DEVIATION 12.03 | 43.79 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 29 Participants | 14 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 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 | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 1 / 16 | 2 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change
Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change.
Time frame: Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Games | Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change | -86.08 percentage change in cigarettes per day | Standard Deviation 22.06 |
| No Mobile Games | Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change | -84.26 percentage change in cigarettes per day | Standard Deviation 30.03 |
p-value: 0.85ANOVA