Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

Not Applicable

Recruiting

• Conditions: Smoking Cessation; Smoking, Cigarette; Smoking Reduction; Smoking; Smoking, Tobacco; Quitting Smoking
• Interventions: Drug: 4 weeks of Nicotine lozenge; Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: Smokefree TXT; Drug: 4 weeks of Nicotine Replacement Therapy Patch; Drug: 8 Weeks Nicotine Lozenge; Behavioral: Tobacco Quitline

• Registration Number: NCT05660525
• Lead Sponsor: University of Virginia

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia.

The main questions it aims to answer are:

* Is QuitAid, alone or combined with other quitting tobacco treatments, effective?

* What makes QuitAid easy or hard to carry out? Is it cost effective? Is it easy to maintain?

Treatment:

All participants will be given at least 4 weeks of the nicotine patch.

Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below).

These groups will be compared to each other to see which combination works best to help them quit smoking.

* Smokefree TXT - a texting program that helps people quit smoking

* Tobacco quitline - 4 phone sessions to help people quit smoking

* 8 weeks of NRT (nicotine replacement therapy in the form of nicotine patches or nicotine patches and lozenge) medication instead of 4 weeks

* QuitAid - An MTM program given by the patient's pharmacist. This is a quitting smoking coaching program

* Nicotine patch AND nicotine lozenge instead of just nicotine patches

Detailed Description

The proposed study uses a mixed-method design to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (Medication Therapy Management) approach, called QuitAid, to smoking cessation in rural Appalachia. Aim 1 of this project will evaluate the effectiveness of QuitAid and standard, evidence-based tobacco treatments on cessation within an MTM pharmacist-delivered approach. Aim 2 will assess implementation, including relative cost of QuitAid, as well as standard, evidence-based tobacco treatments through an ask-advise-connect model, in community pharmacies, and will examine facilitators and barriers to reach, adoption, and maintenance of QuitAid as well as standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies.

Smokers (n=768) recruited through 14 community pharmacies in rural Appalachia will be randomized in a 2x2x2x2x2 full factorial experiment to the following five treatments: (1) QuitAid Intervention (Yes vs. No), (2) tobacco quitline (Yes vs. No), (3) SmokefreeTXT through the National Cancer Institute's (NCI) Smokefree.gov initiative (Yes vs. No), (4) Combination NRT Lozenge + NRT Patch (vs. NRT patch alone), and/or (5) 8 weeks of NRT (vs. standard 4 weeks). Following the experimental trial, we will use an implementation science approach to assess implementation, including relative cost, as well as facilitators and barriers of reach, adoption, and maintenance of QuitAid and standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies (Aim 2).

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2024-03-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2027-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
QuitAid, 4 weeks, Patch + Lozenge	4 weeks of Nicotine lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 4 weeks, Patch + Lozenge	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 4 weeks, Patch + Lozenge	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 8 weeks, Patch + Lozenge	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 8 weeks, Patch + Lozenge	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 8 weeks, Patch + Lozenge	8 Weeks Nicotine Lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
QuitAid, 4 weeks, Patch + Lozenge, QuitLine	4 weeks of Nicotine lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 4 weeks, Patch + Lozenge, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 4 weeks, Patch + Lozenge, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 4 weeks, Patch + Lozenge, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 8 weeks, Patch + Lozenge, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 8 weeks, Patch + Lozenge, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 8 weeks, Patch + Lozenge, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 8 weeks, Patch + Lozenge, QuitLine	8 Weeks Nicotine Lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
QuitAid, 4 weeks, Patch	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
QuitAid, 4 weeks, Patch	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
QuitAid, 8 weeks, Patch	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
QuitAid, 8 weeks, Patch	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
QuitAid, 8 weeks, Patch, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 8 weeks, Patch, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 8 weeks, Patch, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 4 weeks, Patch, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 4 weeks, Patch, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 4 weeks, Patch, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
QuitAid, 4 weeks, Patch, SmokeFree Txt	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch, SmokeFree Txt	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch, SmokeFree Txt	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch, SmokeFree Txt	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch, SmokeFree Txt	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch, SmokeFree Txt	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt	8 Weeks Nicotine Lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt	4 weeks of Nicotine lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	8 Weeks Nicotine Lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	4 weeks of Nicotine lozenge	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine	QuitAid	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	8 Weeks Nicotine Lozenge	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch, SmokeFree Txt, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	4 weeks of Nicotine lozenge	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch, SmokeFree Txt, QuitLine	Smokefree TXT	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch, SmokeFree Txt, QuitLine	Tobacco Quitline	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
4 weeks, Patch, SmokeFree Txt, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
8 weeks, Patch + Lozenge, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
8 weeks, Patch + Lozenge, QuitLine	Tobacco Quitline	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
8 weeks, Patch + Lozenge, QuitLine	8 Weeks Nicotine Lozenge	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
8 weeks, Patch, QuitLine	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
8 weeks, Patch, QuitLine	Tobacco Quitline	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
4 weeks, Patch + Lozenge, QuitLine	4 weeks of Nicotine lozenge	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
4 weeks, Patch + Lozenge, QuitLine	Tobacco Quitline	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
4 weeks, Patch + Lozenge, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
8 weeks, Patch, SmokeFree Txt	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
4 weeks, Patch, QuitLine	Tobacco Quitline	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
4 weeks, Patch, QuitLine	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
8 weeks, Patch + Lozenge, SmokeFree Txt	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
8 weeks, Patch + Lozenge, SmokeFree Txt	Smokefree TXT	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
8 weeks, Patch + Lozenge, SmokeFree Txt	8 Weeks Nicotine Lozenge	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
8 weeks, Patch, SmokeFree Txt	Smokefree TXT	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
4 weeks, Patch + Lozenge, SmokeFree Txt	4 weeks of Nicotine lozenge	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
4 weeks, Patch + Lozenge, SmokeFree Txt	Smokefree TXT	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
4 weeks, Patch + Lozenge, SmokeFree Txt	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
4 weeks, Patch, SmokeFree Txt	Smokefree TXT	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
4 weeks, Patch, SmokeFree Txt	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
8 weeks, Patch + Lozenge	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
8 weeks, Patch + Lozenge	8 Weeks Nicotine Lozenge	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
8 weeks, Patch	8 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
4 weeks, Patch + Lozenge	4 weeks of Nicotine lozenge	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
4 weeks, Patch + Lozenge	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
4 weeks, Patch	4 weeks of Nicotine Replacement Therapy Patch	Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Primary Outcome Measures

Name	Time	Method
Tobacco Abstinence	6 months	The primary outcome is biochemically verified point prevalence (verified through a CO test via Smokerlyzer at endpoint of participation in trial) abstinence defined as no smoking (even a puff) within the past 7 days.

Secondary Outcome Measures

Name	Time	Method
Self-Reported Tobacco Abstinence	1, 2, and 3 months	Self-reported point prevalence abstinence defined as no smoking (even a puff) within the past 7 days
Adherence to assigned treatment components	1, 2, and 3 months	Assess adherence to assigned treatment regimen as the percentage of sessions completed if the participant was assigned to QuitAid and/or the quitline treatments, the frequency of opt-out from SmokefreeTXT (e.g., texting "STOP"), and the percent of NRT used. Adherence to NRT (both patch and/or lozenge) will be collected from participants at the 1-, 2-, and 3-month follow-ups.
Quit Attempts	1, 2, and 3 months	Assess the number of times that participants have made a quit attempt since the previous contact at the 1-, 2-, 3- and 6-month follow-ups. A "quit attempt" will be defined as cigarette abstinence for ≥ 24 hours not due to involuntary or forced cessation (i.e., hospitalization)

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States