A Quit Smoking Study Using Smartphones
Primary Purpose
Smoking Cessation, Smoking, Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch
Cessation Counseling
Mobile Games
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking Cessation, Smoking, Nicotine
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mobile Games
No Mobile Games
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02164383
First Posted
June 11, 2014
Last Updated
March 13, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02164383
Brief Title
A Quit Smoking Study Using Smartphones
Official Title
A Quit Smoking Study Using Smartphones
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Nicotine Dependence
Keywords
Smoking Cessation, Smoking, Nicotine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Games
Arm Type
Experimental
Arm Description
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.
Arm Title
No Mobile Games
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
4-week starter kit of nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Cessation Counseling
Intervention Description
5 brief counseling sessions
Intervention Type
Device
Intervention Name(s)
Mobile Games
Primary Outcome Measure Information:
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya R. Schlam, PhD
Organizational Affiliation
University of Wisconsin Center for Tobacco Research and Intervention
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31536384
Citation
Schlam TR, Baker TB. Playing Around with Quitting Smoking: A Randomized Pilot Trial of Mobile Games as a Craving Response Strategy. Games Health J. 2020 Feb;9(1):64-70. doi: 10.1089/g4h.2019.0030. Epub 2019 Sep 19.
Results Reference
derived
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A Quit Smoking Study Using Smartphones
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