Feasibility of Delivering VergeRx at FQHCs

NCT06161675 | Active Not Recruiting DMC

• 1 other identifier: HSR 230207
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.

Conditions

Tobacco Use Cessation

Keywords

Federally Qualified Health Center; Rural; Appalachia; Smoking Cessation; Readiness to Quit; Pharmacists; Pharmacies; Low Income; Medicaid

Outcome Measures

Primary Outcomes (6)

• Feasibility of Recruitment

  Measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-prescribe, posters, prescription bag advertisements) and (b) the number of smokers recruited per month.

  6 months

• Feasibility of Randomization

  Determine the number of smokers that will needed to be approached and screened in order to randomize 100 smokers (e.g., ineligible smokers, smokers that do not consent) in six months across two FQHCs.

  6 months

• Feasibility of Retention

  Assessment of the proportion of smokers who complete the 12-week follow-up.

  12 weeks

• Dose of the MTM intervention

  Dose of the MTM intervention will be defined at the number of MTM sessions the participant received as documented in the REDCap database by the pharmacists.

  12 weeks

• Dose of the NRT

  Dose of NRT will be defined as the percent of NRT used and will be collected from participants at the follow-ups.

  12 weeks

• Dose of SmokefreeTXT

  Dose of SmokefreeTXT will be defined by the use of keywords, responses to the within-program assessment questions, and date of SmokefreeTXT opt out (i.e., texted "STOP", if applicable).

  12 weeks

Secondary Outcomes (2)

• Biochemical Verification of Tobacco Abstinence by Participants

  12 weeks

• Quit Attempts

  12 weeks

Study Arms (2)

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

EXPERIMENTAL

Participants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.

Behavioral: QuitAid; Behavioral: SmokefreeTXT; Drug: Nicotine Replacement Therapy Patch; Drug: Nicotine lozenge

SmokefreeTXT + NRT (Patch + Lozenge)

ACTIVE COMPARATOR

Participants will receive a texting intervention to help quit smoking and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.

Behavioral: SmokefreeTXT; Drug: Nicotine Replacement Therapy Patch; Drug: Nicotine lozenge

Interventions

QuitAid BEHAVIORAL

Participants will receive the QuitAid intervention, based on a medication adherence intervention, which addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician. Smokers not ready to quit will receive up to two sessions focused on using NRT to cut down cigarette use. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the full QuitAid intervention.

Also known as: Medication Therapy Management (MTM)

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

SmokefreeTXT BEHAVIORAL

All participants will receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. For smokers not ready to quit, participants will receive two week-long pre-quit modules, Practice Quit and Daily Challenges. These modules will help the smoker become comfortable with not smoking for short periods of time and build skills before they attempt to quit. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the ready to quit treatment.

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge); SmokefreeTXT + NRT (Patch + Lozenge)

Nicotine Replacement Therapy Patch DRUG

All participants will receive up to 8 weeks of NRT in the form of patch. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.

Also known as: Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal Product, Habitrol Transdermal Product

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge); SmokefreeTXT + NRT (Patch + Lozenge)

Nicotine lozenge DRUG

All participants will receive up to 8 weeks of NRT in the form of lozenge. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.

Also known as: Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette Lozenge

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge); SmokefreeTXT + NRT (Patch + Lozenge)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient at participating Federally Qualified Health Center
• ≥18 years of age
• able to read, speak, and understand English
• report smoking ≥5 cigarettes per day for the past 6 months
• own a cell phone
• be willing and able to use NRT in the form of patch or lozenge
• not be pregnant or planning to be pregnant in the next 6 months

You may not qualify if:

• have a medical contraindication to NRT (e.g., past 30 days, heart attack or stroke; past 6 months, serious or worsening angina, very rapid or irregular heartbeat requiring medication)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation

Interventions

Medication Therapy Management; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration; Therapeutics

Study Officials

• Melissa A Little, PhD,MPH

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The baseline, 2-, 4-, 8- and 12-week follow-ups will be administered telephonically by trained research assistants blinded to the participant's treatment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Public Health Sciences Director, Center for Tobacco Prevention and Control Research

Model Details: Participants will be randomized via computerized block design after consenting to the study. Equal allocation across treatment combinations will be used and balance between treatment combinations will be maintained by use of randomly permutated blocks. The randomization is not blinded, the study team will know what conditions each subject is randomized to. The randomization schemes will be generated using the R statistical package and will be incorporated into the REDCap database prior to initiation of the study.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: December 8, 2023
• Study Start: September 23, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)