Penn State TXT2Quit Study

Study Overview
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Brief Summary
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This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.

Official Title
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Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Behavioral: Motivational Text Messages
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoke >4 cigarettes/day for at least 6 months Age 21+ Want to quit and ready to try in next 30 days Willing to quit all forms of tobacco (including e-cigs) Willing to use Chantix to try to quit Have a cell phone able to receive text messages Willing to attend 3 visits and use varenicline for smoking cessation Plan to live in local area for next 6 months Read and write in English Women not pregnant and taking steps to avoid Able to understand and willing to sign consent Exclusion Criteria: History of allergic reaction or other adverse event while using varenicline Used a smoking cessation aid/medicine in past 1 month (including e-cigs) Currently pregnant or nursing Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months Uses non-cigarette tobacco products and does not plan to quit all tobacco. Has a history of kidney problems or receives dialysis Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks Had a heart attack in the past 4 weeks Mental conditions that would prohibit the participant from completing the protocol

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Text Messages<br> | Behavioral: Motivational Text Messages<br>* Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.<br>|
| Sham Comparator: Control<br> | Behavioral: Control<br>* Usual Care. All participants receive the active medication, Varenicline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) |  | 12 weeks | 
| Sustained Abstinence at the 12-week Follow up |  | 12 weeks | 
| Number of Days of Varenicline Use |  | 12 weeks | 
| Number of Active Smoking Cessation Activities Used | Number of activities completed out of 6 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. |  | 12 weeks | 
| Time (in Days) to Relapse After the Target Quit Day |  | 12 weeks | 
| Total Score on the Positive Smoking Cessation Activities Measure | Total score for 6 items (scored 0-3). Total score range 0-18. | 12 weeks |