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
DRUGNicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release
14 mg transdermal nicotine patch
DRUGNicotine lozenge
4mg nicotine lozenge
BEHAVIORALAsk-Advise-Refer
All patients will be asked if they smoke, advised to quit, and referred to the state quitline
Sponsors
Sandra Japuntich
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)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
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 | Percentage 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 |
|---|---|---|
| 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 |
| 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 |
| Nicotine Replacement Therapy Utilization | 6 months post baseline | Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline |
| Perceived Nicotine Replacement Therapy Safety | 6 months post baseline | Single item measure of perceived nicotine replacement therapy safety, "Nicotine replacement therapy products (also known as NRT) include the nicotine patch, gum, lozenge, nasal spray, and inhaler. On a scale of 1 to 5, where 1 is not at all and 5 is very, how concerned are you about the safety of NRT products?" For this outcome, we report the change from baseline to the 6 month follow-up. |
| Perceived Nicotine Replacement Therapy Efficacy | 6 months post baseline | Single item measure of perceived nicotine replacement therapy efficacy, "On a scale of 1 to 5, where 1 is not at all, and 5 is very much, how much do you think NRT products improve a smoker's chance of quitting successfully?" For this outcome, we report the change from baseline to the 6 month follow-up. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandra Japuntich
Hennepin Healthcare/University of Minnesota Medical School
Baseline characteristics
| Characteristic | — |
|---|---|
| Acceptability of Intervention Measure | 4.47 units on a scale STANDARD_DEVIATION 0.58 |
| Age, Continuous Patients | 47.46 years STANDARD_DEVIATION 13.08 |
| Age, Continuous practitioners | 43.4 years STANDARD_DEVIATION 12.4 |
| Baseline survey completion Patients | 710 Participants |
| Baseline survey completion practitioners | 36 Participants |
| Ethnicity (NIH/OMB) patients Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) patients Not Hispanic or Latino | 638 Participants |
| Ethnicity (NIH/OMB) patients Unknown or Not Reported | 6 Participants |
| Ethnicity (NIH/OMB) Practitioners Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Practitioners Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Practitioners Unknown or Not Reported | 0 Participants |
| Feasibility of Intervention Measure | 4.38 units on a scale STANDARD_DEVIATION 0.62 |
| Intervention Appropriateness Measure | 4.42 units on a scale STANDARD_DEVIATION 0.58 |
| Organizational Readiness for Change Scale | 53.78 units on a scale STANDARD_DEVIATION 7.45 |
| Region of Enrollment United States | 1239 Participants |
| Sex/Gender, Customized Female patients | 291 Participants |
| Sex/Gender, Customized Female practitioners | 26 Participants |
| Sex/Gender, Customized Male patients | 195 Participants |
| Sex/Gender, Customized Male practitioners | 17 Participants |
| Sex/Gender, Customized missing/other patients | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 710 | 0 / 486 |
| other Total, other adverse events | 543 / 710 | 339 / 486 |
| serious Total, serious adverse events | 0 / 710 | 0 / 486 |
Outcome results
None listed