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OpenTrials
Completed

NCT Number: NCT02164383

A Quit Smoking Study Using Smartphones

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, 53711, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine patch

Drug

4-week starter kit of nicotine patch

Cessation Counseling

Behavioral

5 brief counseling sessions

Mobile Games

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2014
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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