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| ID | Type | Description | Link |
|---|---|---|---|
| UH3DE029973 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| Massachusetts General Hospital | OTHER |
| Northwestern University | OTHER |
| HealthPartners Institute |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric Toothbrush | Active Comparator | 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. |
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| Nicotine Replacement Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ask-Advise-Refer | Behavioral | All patients will be asked if they smoke, advised to quit, and referred to the state quitline |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Japuntich | Hennepin Healthcare/University of Minnesota Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39198824 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 24, 2026 | Mar 13, 2026 | 5 | ||
| Apr 8, 2026 |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| University of Alabama at Birmingham | OTHER |
| Kaiser Permanente | OTHER |
| University of Rochester | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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| Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release | Drug | 14 mg transdermal nicotine patch |
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| Nicotine lozenge | Drug | 4mg nicotine lozenge |
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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 |
| Apr 28, 2026 |
| 6 |
| May 6, 2026 | Jun 1, 2026 | 7 |
| Jun 3, 2026 | Jun 26, 2026 | 8 |
| Jun 29, 2026 |