Free Samples for Health

• Ask-Advise-Refer (Behavioral): All patients will be asked if they smoke, advised to quit, and referred to the state quitline
• Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release (Drug): 14 mg transdermal nicotine patch
• Nicotine lozenge (Drug): 4mg nicotine lozenge

Primary outcomes

• 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 outcomes

• 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
• 7-day Self-reported Point Prevalence Abstinence [3 months post baseline]: Proportion reporting no smoking in the 7 days prior to the 3-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.

Other outcomes

• Organizational Readiness for Change [From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)]: Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the readiness for implementing organizational change (in this case, nicotine replacement therapy sampling). Scores range from 12-60 with higher scores indicating greater readiness for change.
• Acceptability of Intervention Measure [From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)]: Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the acceptability of the intervention of the study (Nicotine replacement therapy sampling). Range is 1-5 with higher scores indicating greater acceptability.
• Intervention Appropriateness Measure [From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)]: Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the intervention appropriateness of the study. cores range from 1-5 with 5 indicating greater appropriateness of nicotine replacement therapy sampling.
• Feasibility of Intervention Measure [From initiation of site enrollment to meeting target recruitment goal or study/site termination, an average of 1 year following recruitment]: Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the feasibility of the intervention of the study. Scores range from 1-5 with higher scores indicating greater feasibility.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• 7-day Biochemically Confirmed Point Prevalence Abstinence (Primary), Count of participants, Participants: Electric Toothbrush Patients 57 (0.65 to 2.09); Nicotine Replacement Therapy Patients 41 (0.65 to 2.09)
• 7-day Self-reported Point Prevalence Abstinence (Secondary), Count of participants, Participants: Electric Toothbrush Patients 64 (1.03 to 2.88); Nicotine Replacement Therapy Patients 62 (1.03 to 2.88)
• 7-day Self-reported Point Prevalence Abstinence (Secondary), Count of participants, Participants: Electric Toothbrush Patients 106; Nicotine Replacement Therapy Patients 66
• 24-hour Intentional Quit Attempts (Secondary), Count of participants, Participants: Electric Toothbrush Patients 346; Nicotine Replacement Therapy Patients 284
• Smoking Heaviness (Secondary), Mean, cigarettes per day: Electric Toothbrush Patients -3.42 +/- 4.76; Nicotine Replacement Therapy Patients -5.12 +/- 7.21
• Nicotine Replacement Therapy Utilization (Secondary), Count of participants, Participants: Electric Toothbrush Patients 90 (5.29 to 10.31); Nicotine Replacement Therapy Patients 243 (5.29 to 10.31)
• Perceived Nicotine Replacement Therapy Safety (Secondary), Mean, units on a scale: Electric Toothbrush Patients -0.70 +/- 1.65; Nicotine Replacement Therapy Patients -0.23 +/- 1.70
• Perceived Nicotine Replacement Therapy Efficacy (Secondary), Mean, units on a scale: Electric Toothbrush Patients -0.28 +/- 1.41; Nicotine Replacement Therapy Patients -0.04 +/- 1.42
• Organizational Readiness for Change (Other pre specified), Mean, units on a scale: Nicotine Replacement Therapy Practitioners 50.58 +/- 11.29
• Acceptability of Intervention Measure (Other pre specified), Mean, units on a scale: Nicotine Replacement Therapy Practitioners 4.46 +/- 0.63
• Intervention Appropriateness Measure (Other pre specified), Mean, units on a scale: Nicotine Replacement Therapy Practitioners 4.46 +/- 0.69
• Feasibility of Intervention Measure (Other pre specified), Mean, units on a scale: Nicotine Replacement Therapy Practitioners 4.32 +/- 0.81

Adverse events

Time frame: from baseline to six-months

Other adverse events by term

• Results publication: Fang P, Adkins-Hempel M, Lischka T, Basile S, Rindal DB, Carpenter MJ, Kopycka-Kedzierawski DT, Dahne J, Helseth SA, Levy DE, Truong A, Leo MC, Funkhouser K, Louis DR, Japuntich SJ; National Dental PBRN Collaborative group. A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study. BMC Oral Health. 2024 Aug 28;24(1):1007. doi: 10.1186/s12903-024-04758-w. PMID 39198824

• Study Protocol and Statistical Analysis Plan (PDF, 2024-06-25)

• Sandra Japuntich, Principal investigator, Hennepin Healthcare/University of Minnesota Medical School

NIH grants: UH3DE029973