Recruiting

Nicotine Replacement Therapy

Sponsor:

University of Pennsylvania

Code:

NCT07735286

Conditions

Tobacco Use

Tobacco Use Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tobacco counseling resources

Study Details

Brief summary:

This study focuses on improving how primary care teams identify patients who smoke and offer access to nicotine replacement therapy, or NRT. NRT includes medications such as nicotine patches, gum, or lozenges that can reduce cravings and support people who are interested in cutting back or quitting smoking. Although NRT is an evidence-based treatment option, it is not always discussed or prescribed during routine primary care visits. To better understand how NRT can be offered in primary care, the project will test a workflow at Penn Family Care that identifies patients who currently smoke and provides information about available tobacco treatment options. Edward Cooper Internal Medicine will serve as a comparison site. Patients who smoke and/or are prescribed NRT will also receive a 30-day follow-up survey to learn whether they received, picked up, or used NRT; whether it was useful; and what barriers they experienced.

Conditions

Tobacco Use

Tobacco Use Cessation

Study ID

NCT07735286

Start date

Sep 24, 2026

Status verified date

Oct, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Mar 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Patient at Penn Family Care or Edward Cooper Internal Medicine
  • Had an eligible scheduled or completed practice visit categorized as a new annual visit, return patient visit, return annual visit, or return patient sick visit
  • For the tobacco cessation intervention: Penn Family Care patient who had not previously completed the tobacco questionnaire
  • For the 30-day follow-up survey: Active smoker in the EHR as of the completed visit date or prescribed nicotine replacement therapy (NRT) between 3 days before and 30 days after the completed visit date
  • For the primary analysis: Active smoker in the EHR as of the completed visit date
  • For the primary analysis: Did not have an NRT prescription between 34 and 4 days before the completed visit date

Exclusion Criteria:

  • None except as specified in inclusion criteria.

Study Design

Enrollment

4800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Penn Family Care (Treatment)

Interested participants will receive a text with tobacco counseling resources

no intervention: Arm 2: Edward Cooper Internal Medicine (Usual Practice)

No text with tobacco counseling resources

Interventions

Tobacco counseling resources

Participants who are in the intervention arm will receive tobacco counseling resources via the Way to Health platform. Way to Health will send text message links to tobacco cessation counseling resources (PA Quitline and/or SmokeFreeTXT).

Primary outcome measure

  • Proportion of Active Smokers with a Signed NRT Prescription [ Time Frame: From 3 days before scheduled visit and 30 days after completed visit. ]

Central Contacts and Locations

Central contacts

Senior Project Manager, MSW

609-534-0751nathalie.laurent@pennmedicine.upenn.edu

Locations

Penn Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Senior Project Manager, MSW

609-534-0751nathalie.laurent@pennmedicine.upenn.edu

Principal Investigator:

Cheryl Bettigole, MD, MPH

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.