Smoking CessationNCT02164383
A Quit Smoking Study Using Smartphones
A study testing Nicotine patch, Cessation Counseling and Mobile Games in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking, Nicotine Dependence
- What is being tested?
- Nicotine patch, Cessation Counseling and Mobile Games
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711
About this study
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.
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Being tested
- Nicotine patch, Cessation Counseling, Mobile Games
- Keywords
- Smoking Cessation, Smoking, Nicotine
- Medical subject headings
- Smoking Cessation, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
4-week starter kit of nicotine patch
Cessation CounselingBehavioural
5 brief counseling sessions
Mobile GamesDevice
| Study group | Role | What they receive |
|---|---|---|
| Mobile Games | Experimental | 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. Receives: Drug: Nicotine patch; Behavioral: Cessation Counseling; Device: Mobile Games |
| No Mobile Games | Experimental | 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. Receives: Drug: Nicotine patch; Behavioral: Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tanya R. Schlam, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164383
- Sponsor's protocol ID
- 2013-1606
- Other IDs
- P50CA143188
- Status last verified
- Mar 2019
- First submitted
- 11 Jun 2014
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31536384
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quit Smoking Study Using Smartphones
- ClinicalTrials.gov ID
- NCT02164383
- Acronym / sponsor ID
- 2013-1606
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Keywords
- Smoking Cessation, Smoking, Nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Games | Experimental | Drug: Nicotine patch, Behavioral: Cessation Counseling, Device: Mobile GamesThis 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. |
| No Mobile Games | Experimental | Drug: Nicotine patch, Behavioral: Cessation CounselingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Nicotine patch4-week starter kit of nicotine patch | Drug | Mobile Games, No Mobile Games |
| Cessation Counseling5 brief counseling sessions | Behavioural | Mobile Games, No Mobile Games |
| Mobile Games | Device | Mobile Games |
Primary outcome
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31536384Schlam 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.
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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.
Tanya R. Schlam, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch, Cessation Counseling and Mobile Games in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison 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 21 inclusion and 1 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 3 Apr 2019. 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 3 Apr 2019). 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?
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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164383, which also lists 1 linked publication.
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 3 Apr 2019; AzTrials last refreshed its copy on 28 Oct 2026.