A Quit Smoking Study Using Smartphones

March 13, 2019 updated by: University of Wisconsin, Madison
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Games

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.
Drug: Nicotine patch
4-week starter kit of nicotine patch
Behavioral: Cessation Counseling
5 brief counseling sessions
Device: Mobile Games
Experimental: No 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.
Drug: Nicotine patch
4-week starter kit of nicotine patch
Behavioral: Cessation Counseling
5 brief counseling sessions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tanya R. Schlam, PhD, University of Wisconsin Center for Tobacco Research and Intervention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-1606
  • P50CA143188 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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