Free Samples for Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ask-Advise-Refer

Intervention Type BEHAVIORAL

All patients will be asked if they smoke, advised to quit, and referred to the state quitline

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.

Group Type EXPERIMENTAL

Ask-Advise-Refer

Intervention Type 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

Intervention Type DRUG

14 mg transdermal nicotine patch

Nicotine lozenge

Intervention Type DRUG

4mg nicotine lozenge

Interventions

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Ask-Advise-Refer

All patients will be asked if they smoke, advised to quit, and referred to the state quitline

Intervention Type BEHAVIORAL

Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release

14 mg transdermal nicotine patch

Intervention Type DRUG

Nicotine lozenge

4mg nicotine lozenge

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No