Free Samples for Health

Phase 2

• Conditions: Cigarette Smoking
• Interventions: Behavioral: Ask-Advise-Refer; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release; Drug: Nicotine lozenge

• Registration Number: NCT05627596
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-25
• Study Start: 2023-06-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-05-28
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• ≥ 18 years old
• smokes at least 1 combustible cigarette per day on at least 25 days of the month

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy	Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release	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.
Nicotine Replacement Therapy	Nicotine lozenge	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.
Electric Toothbrush	Ask-Advise-Refer	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.
Nicotine Replacement Therapy	Ask-Advise-Refer	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 Measures

Name	Time	Method
7-day biochemically confirmed point prevalence abstinence	6 months post baseline	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

Secondary Outcome Measures

Name	Time	Method
7-day self-reported point prevalence abstinence	1 month post baseline	Proportion reporting no smoking in the 7 days prior to the 3-month follow-up
24-hour intentional quit attempts	6 months post baseline	proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study
Smoking heaviness	6 months post baseline	Change in cigarettes smoked per day from baseline to the 6 month follow-up
Nicotine replacement therapy utilization	6 months post baseline	Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline
Perceived nicotine replacement therapy safety	6 months post baseline	Change in self-reported perception of nicotine replacement therapy safety from baseline to 6-month follow-up
Perceived nicotine replacement therapy efficacy	6 months post baseline	Change in self-reported perception of nicotine replacement therapy efficacy from baseline to 6-month follow-up

Trial Locations

Locations (1)

Hennepin Healthcare Research Institute; 🇺🇸 Minneapolis, Minnesota, United States