NCT05627596

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

November 16, 2022

Last Update Submit

May 28, 2024

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 7-day self-reported point prevalence abstinence

    1 month post baseline

  • 7-day self-reported point prevalence abstinence

    1 month post baseline

  • 24-hour intentional quit attempts

    6 months post baseline

  • Smoking heaviness

    6 months post baseline

  • Nicotine replacement therapy utilization

    6 months post baseline

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Ask-Advise-ReferDrug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended ReleaseDrug: Nicotine lozenge

Interventions

Ask-Advise-ReferBEHAVIORAL

All patients will be asked if they smoke, advised to quit, and referred to the state quitline

Electric ToothbrushNicotine Replacement Therapy
Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended ReleaseDRUG

14 mg transdermal nicotine patch

Nicotine Replacement Therapy
Nicotine lozengeDRUG

4mg nicotine lozenge

Nicotine Replacement Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • 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.

    PMID: 39198824DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sandra Japuntich

    Hennepin Healthcare/University of Minnesota Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

June 12, 2023

Primary Completion

May 28, 2025

Study Completion

July 31, 2025

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

US(1)