Feasibility of Delivering VergeRx at FQHCs

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

July 1, 2025

Study Completion Date

July 1, 2026

Conditions
Tobacco Use Cessation
Interventions
BEHAVIORAL

QuitAid

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.

BEHAVIORAL

SmokefreeTXT

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.

DRUG

Nicotine Replacement Therapy Patch

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.

DRUG

Nicotine lozenge

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.

Trial Locations (1)

22903

RECRUITING

University of Virginia, Charlottesville

All Listed Sponsors
lead

University of Virginia

OTHER