Hollings Cancer Center Varenicline Sampling Study

Study Overview
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Brief Summary
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The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not. Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking. Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called varenicline sampling. The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.

Official Title
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A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation

Conditions
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Smoking, Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette

Intervention / Treatment
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* Drug: Varenicline 0.5 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18+ daily smoker (25+ days/previous month) smoking 5+ cigarettes/day; smoking > 1yr; some interest in eventual quitting (>2 on 10-point scale); has a primary care doctor and has seen that doctor at least once in past year; and own a smartphone or have regular (daily) access/use of email. Exclusion Criteria: reports of history of seizures or seizure disorders; suicidal ideation in past month; any lifetime suicide attempt; currently pregnant, breastfeeding, or planning to become pregnant; or reports of hallucinations.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline Group<br>50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. | Drug: Varenicline 0.5 MG<br>* varenicline comes in bottles of 56 - 0.5 mg pills<br>* Other names: Varenicline Pill;|
| No Intervention: Control Group<br>49 participants will be enrolled in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Attempts | Percent of participants with any self-defined and any self-defined 24-hr quit attempt | From study enrollment through end of three-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion of Varenicline Use | Percent of participants in the sampling group using varenicline at 3-month follow up assessment. | At the end of the three-month follow up |