A Quit Smoking Study Using Smartphones

NCT ID: NCT02164383

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

Smoking Cessation; Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

4-week starter kit of nicotine patch

Cessation Counseling

Intervention Type: BEHAVIORAL

5 brief counseling sessions

Mobile Games

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

4-week starter kit of nicotine patch

Cessation Counseling

Intervention Type: BEHAVIORAL

5 brief counseling sessions

Interventions

Nicotine patch

4-week starter kit of nicotine patch

Intervention Type: DRUG

Cessation Counseling

5 brief counseling sessions

Intervention Type: BEHAVIORAL

Mobile Games

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya R. Schlam, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31536384 (View on PubMed)

Other Identifiers

P50CA143188

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-1606

Identifier Type: -

Identifier Source: org_study_id