Text Messaging for Smoking Cessation in College Health Clinics

Study Overview
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Brief Summary
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This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college. The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.

Official Title
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Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Smoking counseling
* Behavioral: Text messaging
* Drug: Nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 through 24 years Enrolled as a full/part time college student A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days) English-speaking Interested in quitting Have a cell phone for personal use with an unlimited text messaging plan. Exclusion Criteria: History of hypersensitivity/allergy to nicotine patch; Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease) Current pregnancy/breastfeeding/plan for pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text messaging<br>Smoking counseling, nicotine patch, text messaging | Behavioral: Smoking counseling<br> <br> Behavioral: Text messaging<br> <br> Drug: Nicotine patch<br> <br> |
| Active Comparator: Standard of care<br>Smoking counseling, nicotine patch | Behavioral: Smoking counseling<br> <br> Drug: Nicotine patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Enrollment- Number of Participants Who Join the Study | We will report the number of persons who join the study. | baseline | 
| Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit. | 6- and 12- weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | biochemically confirmed point prevalence of self reported past 7-day abstinence | 6- and 12- weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette smoking, tobacco use cessation products