Free Samples for Health (FreSH)

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: Ask-Advise-Refer; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release; Drug: Nicotine lozenge

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Ask-Advise-Refer; All patients will be asked if they smoke, advised to quit, and referred to the state quitline
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.	Behavioral: Ask-Advise-Refer; All patients will be asked if they smoke, advised to quit, and referred to the state quitline; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release; 14 mg transdermal nicotine patch; Drug: Nicotine lozenge; 4mg nicotine lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: Medical University of South Carolina; Massachusetts General Hospital; Northwestern University; University of Alabama at Birmingham; National Institute of Dental and Craniofacial Research (NIDCR); University of Rochester; HealthPartners Institute; Kaiser Permanente
• Investigators: Principal Investigator: Sandra Japuntich, Hennepin Healthcare/University of Minnesota Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): May 28, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: UH3DE029973 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No