A Quit Smoking Study Using Smartphones

Study Overview
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Brief Summary
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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.

Official Title
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A Quit Smoking Study Using Smartphones

Conditions
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Smoking Cessation, Smoking, Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine patch
* Behavioral: Cessation Counseling
* Device: Mobile Games


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Games<br>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<br>* 4-week starter kit of nicotine patch<br>Behavioral: Cessation Counseling<br>* 5 brief counseling sessions<br>Device: Mobile Games<br> <br> |
| Experimental: No Mobile Games<br>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<br>* 4-week starter kit of nicotine patch<br>Behavioral: Cessation Counseling<br>* 5 brief counseling sessions<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Smoking, Nicotine