Free Samples for Health

Cigarette Smoking Clinical Trial

— FreSH  

Official title:

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05627596
• Other study ID #: UH3DE029973
• Secondary ID: UH3DE029973
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 12, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: July 31, 2025
• Est. primary completion date: May 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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
• Nicotine lozenge
4mg nicotine lozenge

Locations

Country	Name	City	State
United States	Hennepin Healthcare Research Institute	Minneapolis	Minnesota

Sponsors (9)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	HealthPartners Institute, Kaiser Permanente, Massachusetts General Hospital, Medical University of South Carolina, National Institute of Dental and Craniofacial Research (NIDCR), Northwestern University, University of Alabama at Birmingham, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Smoking heaviness	Change in cigarettes smoked per day from baseline to the 6 month follow-up	6 months post baseline
Secondary	Nicotine replacement therapy utilization	Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline	6 months post baseline
Secondary	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
Secondary	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