Clinical trial NCT02164383: A Quit Smoking Study Using Smartphones
Official title: A Quit Smoking Study Using Smartphones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking
Nicotine Dependence
Keywords: Smoking Cessation
Smoking
Nicotine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tanya R. Schlam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.