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Completed

NCT Number: NCT05627596

Free Samples for Health

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).

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Key information

Conditions

Cigarette Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 7-day Biochemically Confirmed Point Prevalence Abstinence

    Time frame: 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

  1. 7-day Self-reported Point Prevalence Abstinence

    Time frame: 1 month post baseline

    Proportion reporting no smoking in the 7 days prior to the 1-month follow-up

  2. 7-day Self-reported Point Prevalence Abstinence

    Time frame: 3 months post baseline

    Proportion reporting no smoking in the 7 days prior to the 3-month follow-up

  3. 24-hour Intentional Quit Attempts

    Time frame: 6 months post baseline

    proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study

  4. Smoking Heaviness

    Time frame: 6 months post baseline

    Change in cigarettes smoked per day from baseline to the 6 month follow-up

  5. Nicotine Replacement Therapy Utilization

    Time frame: 6 months post baseline

    Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline

  6. Perceived Nicotine Replacement Therapy Safety

    Time frame: 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.

  7. Perceived Nicotine Replacement Therapy Efficacy

    Time frame: 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

  1. Organizational Readiness for Change

    Time frame: 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.

  2. Acceptability of Intervention Measure

    Time frame: 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.

  3. Intervention Appropriateness Measure

    Time frame: 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.

  4. Feasibility of Intervention Measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sandra Japuntich

Other

Collaborators

  • HealthPartners Institute
  • Kaiser Permanente
  • Massachusetts General Hospital
  • Medical University of South Carolina
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Northwestern University
  • University of Alabama at Birmingham
  • University of Rochester

Registry information

Official study title

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

Acronym: FreSH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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