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Clinical trial

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

ID
Name
UH3DE029973
Description
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).
Trial arms
Trial start
2023-06-12
Estimated PCD
2025-05-28
Trial end
2025-07-31
Phase
Early phase I
Treatment
Ask-Advise-Refer
All patients will be asked if they smoke, advised to quit, and referred to the state quitline
Arms:
Electric Toothbrush, Nicotine Replacement Therapy
Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release
14 mg transdermal nicotine patch
Arms:
Nicotine Replacement Therapy
Nicotine lozenge
4mg nicotine lozenge
Arms:
Nicotine Replacement Therapy
Size
1200
Primary endpoint
7-day biochemically confirmed point prevalence abstinence
6 months post baseline
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

2 products

1 indication

Organization
Hennepin Healthcare Research Institute
Product
Nicotine Patch
Indication
Smoking
Product
Nicotine