Free Samples for Health

Study Overview
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Brief Summary
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The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).

Official Title
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Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Ask-Advise-Refer
* Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release
* Drug: Nicotine lozenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old smokes at least 1 combustible cigarette per day on at least 25 days of the month Exclusion Criteria: does not own a smartphone with internet access myocardial infarction or stroke in the past 3 months pregnant or breastfeeding use of tobacco cessation medication in the past week

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electric Toothbrush<br>Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush. | Behavioral: Ask-Advise-Refer<br>* All patients will be asked if they smoke, advised to quit, and referred to the state quitline<br>|
| Experimental: Nicotine Replacement Therapy<br>Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges. | Behavioral: Ask-Advise-Refer<br>* All patients will be asked if they smoke, advised to quit, and referred to the state quitline<br>Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release<br>* 14 mg transdermal nicotine patch<br>Drug: Nicotine lozenge<br>* 4mg nicotine lozenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day biochemically confirmed point prevalence abstinence | Proportion reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million | 6 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day self-reported point prevalence abstinence | Proportion reporting no smoking in the 7 days prior to the 1-month follow-up | 1 month post baseline | 
| 7-day self-reported point prevalence abstinence | Proportion reporting no smoking in the 7 days prior to the 3-month follow-up | 1 month post baseline | 
| 24-hour intentional quit attempts | proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study | 6 months post baseline | 
| Smoking heaviness | Change in cigarettes smoked per day from baseline to the 6 month follow-up | 6 months post baseline | 
| Nicotine replacement therapy utilization | Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline | 6 months post baseline | 
| Perceived nicotine replacement therapy safety | Change in self-reported perception of nicotine replacement therapy safety from baseline to 6-month follow-up | 6 months post baseline | 
| Perceived nicotine replacement therapy efficacy | Change in self-reported perception of nicotine replacement therapy efficacy from baseline to 6-month follow-up | 6 months post baseline |