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 — 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

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 Toothbrush
    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.
  • Experimental: Nicotine Replacement Therapy
    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.

Primary Outcome Measure

7-day biochemically confirmed point prevalence abstinence [ Time Frame: 6 months post baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hennepin Healthcare Research InstituteMinneapolisMinnesota55415-

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