Free Samples for Health
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- Hennepin Healthcare Research Institute
- Study ID
- NCT05627596
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Cigarette Smoking
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ask-Advise-Refer — BEHAVIORALAll 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 — DRUG14 mg transdermal nicotine patch
- Nicotine lozenge — DRUG4mg nicotine lozenge
Study Details
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).
Key Dates
- Start date
- Jun 12, 2023
- Status verified
- May 2024
- Primary completion
- May 28, 2025
- Completion
- Jul 31, 2025
Study Design
- Enrollment
- 1,200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Electric ToothbrushParticipants 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.
- Experimental: Nicotine Replacement TherapyParticipants 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.
Primary Outcome Measure
7-day biochemically confirmed point prevalence abstinence [ Time Frame: 6 months post baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | - |
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