Cigarette Smoking
Conditions
Brief summary
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).
Interventions
BEHAVIORALAsk-Advise-Refer
All patients will be asked if they smoke, advised to quit, and referred to the state quitline
DRUGNicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release
14 mg transdermal nicotine patch
DRUGNicotine lozenge
4mg nicotine lozenge
Sponsors
Medical University of South Carolina
Massachusetts General Hospital
Northwestern University
HealthPartners Institute
University of Alabama at Birmingham
Kaiser Permanente
University of Rochester
National Institute of Dental and Craniofacial Research (NIDCR)
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day biochemically confirmed point prevalence abstinence | 6 months post baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour intentional quit attempts | 6 months post baseline | proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study |
| Smoking heaviness | 6 months post baseline | Change in cigarettes smoked per day from baseline to the 6 month follow-up |
| 7-day self-reported point prevalence abstinence | 1 month post baseline | Proportion reporting no smoking in the 7 days prior to the 1-month follow-up |
| Perceived nicotine replacement therapy safety | 6 months post baseline | Change in self-reported perception of nicotine replacement therapy safety from baseline to 6-month follow-up |
| Perceived nicotine replacement therapy efficacy | 6 months post baseline | Change in self-reported perception of nicotine replacement therapy efficacy from baseline to 6-month follow-up |
| Nicotine replacement therapy utilization | 6 months post baseline | Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline |
Countries
United States
Outcome results
None listed