NCT02164383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 3, 2019

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

June 11, 2014

Results QC Date

March 12, 2019

Last Update Submit

March 13, 2019

Conditions

Keywords

Smoking CessationSmokingNicotine

Outcome Measures

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

    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

Study Arms (2)

Mobile Games

EXPERIMENTAL

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 patchBehavioral: Cessation CounselingDevice: Mobile Games

No Mobile Games

EXPERIMENTAL

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 patchBehavioral: Cessation Counseling

Interventions

4-week starter kit of nicotine patch

Mobile GamesNo Mobile Games

5 brief counseling sessions

Mobile GamesNo Mobile Games
Mobile Games

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking CessationSmokingTobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Tanya Schlam, PhD
Organization
University of Wisconsin Center for Tobacco Research and Intervention

Study Officials

  • Tanya R. Schlam, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 16, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 3, 2019

Results First Posted

April 3, 2019

Record last verified: 2019-03

Locations