Free Samples for Health (FreSH)

Hennepin Healthcare

Status and phase: Invitation-only; Phase 2

Conditions: Cigarette Smoking

Treatments: Behavioral: Ask-Advise-Refer; Drug: Nicotine lozenge; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05627596

UH3DE029973

Details and patient eligibility

About

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).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

1,200 participants in 2 patient groups

Electric Toothbrush

Active Comparator group

Description:

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.

Treatment:

Behavioral: Ask-Advise-Refer

Nicotine Replacement Therapy

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release

Drug: Nicotine lozenge

Behavioral: Ask-Advise-Refer