FreSH: Free Samples for Health

• Sponsor: Hennepin Healthcare Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05627596
• Collaborator: Medical University of South Carolina (Other), Massachusetts General Hospital (Other), Northwestern University (Other), HealthPartners Institute (Other), University of Alabama at Birmingham (Other), Kaiser Permanente (Other), University of Rochester (Other)
• Enrollment: 1,200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.9
• Patients Per Site Per Month: 40.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking	Behavioral: Ask-Advise-Refer; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release; Drug: Nicotine lozenge	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 28, 2025
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 7-day self-reported point prevalence abstinence [1 month post baseline]

   Proportion reporting no smoking in the 7 days prior to the 1-month follow-up

2. 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

3. 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

4. Smoking heaviness [6 months post baseline]

   Change in cigarettes smoked per day from baseline to the 6 month follow-up

5. Nicotine replacement therapy utilization [6 months post baseline]

   Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hennepin Healthcare Research Institute	Minneapolis	Minnesota	United States	55415

Sponsors and Collaborators

• Hennepin Healthcare Research Institute
• Medical University of South Carolina
• Massachusetts General Hospital
• Northwestern University
• HealthPartners Institute
• University of Alabama at Birmingham
• Kaiser Permanente
• University of Rochester

Investigators

• Principal Investigator: Sandra Japuntich, Hennepin Healthcare/University of Minnesota Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT05627596
• Other Study ID Numbers: UH3DE029973
• First Posted: Nov 25, 2022
• Last Update Posted: Nov 25, 2022
• Last Verified: Nov 1, 2022

• 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
• Additional relevant MeSH terms: Nicotine

Study Results

No Results Posted as of Nov 25, 2022