A Quit Smoking Study Using Smartphones

Smoking Cessation Clinical Trial

Official title:

A Quit Smoking Study Using Smartphones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164383
• Other study ID #: 2013-1606
• Secondary ID: P50CA143188
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 without such access.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch
4-week starter kit of nicotine patch

Behavioral:
• Cessation Counseling
5 brief counseling sessions

Device:
• Mobile Games

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline