Cigarette SmokingPhase 2FreSHNCT05627596

Free Samples for Health

A Phase 2 study testing Ask-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release and Nicotine lozenge in people with Cigarette Smoking, run by Sandra Japuntich at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cigarette Smoking
What is being tested?: Ask-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release and Nicotine lozenge
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,239 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2023to 24 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years old
smokes at least 1 combustible cigarette per day on at least 25 days of the month

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

Conditions: Cigarette Smoking
Being tested: Ask-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release, Nicotine lozenge
Medical subject headings: Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ask-Advise-ReferBehavioural
All patients will be asked if they smoke, advised to quit, and referred to the state quitline
Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended ReleaseDrug
14 mg transdermal nicotine patch
Nicotine lozengeDrug
4mg nicotine lozenge

Study groups in NCT05627596
Study group	Role	What they receive
Electric Toothbrush	Active comparator	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. Receives: Behavioral: Ask-Advise-Refer
Nicotine Replacement Therapy	Experimental	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. Receives: Behavioral: Ask-Advise-Refer; Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release; Drug: Nicotine lozenge

What is being measured

The primary outcome is the main question the study is designed to answer.

7-day Biochemically Confirmed Point Prevalence Abstinence
Percentage 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
Measured: 6 months post baseline

Secondary outcomes (7)

7-day Self-reported Point Prevalence Abstinence
Proportion reporting no smoking in the 7 days prior to the 1-month follow-up
Measured: 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
Measured: 3 months 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
Measured: 6 months post baseline
Smoking Heaviness
Change in cigarettes smoked per day from baseline to the 6 month follow-up
Measured: 6 months post baseline
Nicotine Replacement Therapy Utilization
Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline
Measured: 6 months post baseline
Perceived Nicotine Replacement Therapy Safety
Single item measure of perceived nicotine replacement therapy safety, "Nicotine replacement therapy products (also known as NRT) include the nicotine patch, gum, lozenge, nasal spray, and inhaler. On a scale of 1 to 5, where 1 is not at all and 5 is very, how concerned are you about the safety of NRT products?" For this outcome, we report the change from baseline to the 6 month follow-up.
Measured: 6 months post baseline
Perceived Nicotine Replacement Therapy Efficacy
Single item measure of perceived nicotine replacement therapy efficacy, "On a scale of 1 to 5, where 1 is not at all, and 5 is very much, how much do you think NRT products improve a smoker's chance of quitting successfully?" For this outcome, we report the change from baseline to the 6 month follow-up.
Measured: 6 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 202324 Jun 2025

First posted25 Nov 2022
Study start12 Jun 2023
Primary completion24 Jun 2025
Study completion24 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 1,239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05627596
Sponsor's protocol ID: UH3DE029973
Other IDs: UH3DE029973
Acronym: FreSH
Status last verified: Jun 2026
First submitted: 16 Nov 2022
Last updated: 24 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Fang P, Adkins-Hempel M, Lischka T, Basile S, Rindal DB, Carpenter MJ, Kopycka-Kedzierawski DT, Dahne J, Helseth SA, Levy DE, Truong A, Leo MC, Funkhouser K, Louis DR, Japuntich SJ; National Dental PBRN Collaborative group. A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study. BMC Oral Health. 2024 Aug 28;24(1):1007. doi: 10.1186/s12903-024-04758-w.
PubMed 39198824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cigarette Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices
ClinicalTrials.gov ID: NCT05627596
Acronym / sponsor ID: FreSH / UH3DE029973
Conditions: Cigarette Smoking
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,239 participants (actual)
Lead sponsor: Sandra JapuntichUniversity, hospital or other
Collaborators: Medical University of South Carolina, Massachusetts General Hospital, Northwestern University, HealthPartners Institute, University of Alabama at Birmingham, Kaiser Permanente, University of Rochester, National Institute of Dental and Craniofacial Research (NIDCR)
Study start: 12 Jun 2023 (actual)
Primary completion: 24 Jun 2025 (actual)
Study completion: 24 Jun 2025 (actual)
First posted: 25 Nov 2022 (actual)
Results: Posted 24 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Electric Toothbrush	Active comparator	Behavioral: Ask-Advise-ReferParticipants 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.
Nicotine Replacement Therapy	Experimental	Behavioral: Ask-Advise-Refer, Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release, Drug: Nicotine lozengeParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

≥ 18 years old
smokes at least 1 combustible cigarette per day on at least 25 days of the month

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ask-Advise-ReferAll patients will be asked if they smoke, advised to quit, and referred to the state quitline	Behavioural	Electric Toothbrush, Nicotine Replacement Therapy
Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release14 mg transdermal nicotine patch	Drug	Nicotine Replacement Therapy
Nicotine lozenge4mg nicotine lozenge	Drug	Nicotine Replacement Therapy

Primary outcome

7-day Biochemically Confirmed Point Prevalence Abstinence
Time frame: 6 months post baseline
Percentage 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

7 secondary outcomes

7-day Self-reported Point Prevalence Abstinence
Time frame: 1 month post baseline
7-day Self-reported Point Prevalence Abstinence
Time frame: 3 months post baseline
24-hour Intentional Quit Attempts
Time frame: 6 months post baseline
Smoking Heaviness
Time frame: 6 months post baseline
Nicotine Replacement Therapy Utilization
Time frame: 6 months post baseline
Perceived Nicotine Replacement Therapy Safety
Time frame: 6 months post baseline
Perceived Nicotine Replacement Therapy Efficacy
Time frame: 6 months post baseline

Results and safety

Results posted to the registry on 24 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electric Toothbrush Patients	710	526
Nicotine Replacement Therapy	529	353

Primary outcome: 7-day Biochemically Confirmed Point Prevalence Abstinence

Time frame: 6 months post baseline. Count of participants. Unit: Participants

Measure	Electric Toothbrush Patients n = 710	Nicotine Replacement Therapy Patients n = 486
Value	57 (0.65 to 2.09)	41 (0.65 to 2.09)

Population analysed: This outcome only applies to patient participants.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: from baseline to six-months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Electric Toothbrush Patients	0 of 710 (0%)	543 of 710 (76.5%)	0 of 710
Nicotine Replacement Therapy Patients	0 of 486 (0%)	339 of 486 (69.8%)	0 of 486

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39198824Fang P, Adkins-Hempel M, Lischka T, Basile S, Rindal DB, Carpenter MJ, Kopycka-Kedzierawski DT, Dahne J, Helseth SA, Levy DE, Truong A, Leo MC, Funkhouser K, Louis DR, Japuntich SJ; National Dental PBRN Collaborative group. A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study. BMC Oral Health. 2024 Aug 28;24(1):1007. doi: 10.1186/s12903-024-04758-w.

Related trials for Cigarette Smoking

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
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Active, not recruiting
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
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Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra Japuntich principal investigator

Hennepin Healthcare/University of Minnesota Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Biochemically Confirmed Point Prevalence Abstinence (time frame: 6 months post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05627596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.