NCT05660525

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
768

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress54%
Mar 2024Mar 2028

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

December 13, 2022

Last Update Submit

April 16, 2026

Conditions

Smoking, CigaretteSmoking ReductionSmoking, TobaccoQuitting SmokingSmoking CessationSmoking

Outcome Measures

Primary Outcomes (1)

  • Tobacco Abstinence

    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.

    6 months

Secondary Outcomes (3)

  • Self-Reported Tobacco Abstinence

    1, 2, and 3 months

  • Adherence to assigned treatment components

    1, 2, and 3 months

  • Quit Attempts

    1, 2, and 3 months

Study Arms (32)

QuitAid, 4 weeks, Patch + Lozenge

EXPERIMENTAL

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.

Drug: 4 weeks of Nicotine lozengeBehavioral: QuitAidDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidDrug: 8 Weeks Nicotine Lozenge

QuitAid, 4 weeks, Patch + Lozenge, QuitLine

EXPERIMENTAL

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

Drug: 4 weeks of Nicotine lozengeBehavioral: QuitAidBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge, QuitLine

EXPERIMENTAL

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

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Tobacco QuitlineDrug: 8 Weeks Nicotine Lozenge

QuitAid, 4 weeks, Patch

EXPERIMENTAL

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.

Behavioral: QuitAidDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAid

QuitAid, 8 weeks, Patch, QuitLine

EXPERIMENTAL

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

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Tobacco Quitline

QuitAid, 4 weeks, Patch, QuitLine

EXPERIMENTAL

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

Behavioral: QuitAidBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch, SmokeFree Txt

EXPERIMENTAL

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.

Behavioral: QuitAidBehavioral: Smokefree TXTDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch, SmokeFree Txt

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Smokefree TXT

QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Smokefree TXTDrug: 8 Weeks Nicotine Lozenge

QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt

EXPERIMENTAL

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.

Drug: 4 weeks of Nicotine lozengeBehavioral: QuitAidBehavioral: Smokefree TXTDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 8 Weeks Nicotine Lozenge

QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: QuitAidBehavioral: Smokefree TXTBehavioral: Tobacco Quitline

QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 4 weeks of Nicotine lozengeBehavioral: QuitAidBehavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Behavioral: QuitAidBehavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 8 Weeks Nicotine Lozenge

8 weeks, Patch, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Smokefree TXTBehavioral: Tobacco Quitline

4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Drug: 4 weeks of Nicotine lozengeBehavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch, SmokeFree Txt, QuitLine

EXPERIMENTAL

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.

Behavioral: Smokefree TXTBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch + Lozenge, QuitLine

EXPERIMENTAL

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Tobacco QuitlineDrug: 8 Weeks Nicotine Lozenge

8 weeks, Patch, QuitLine

EXPERIMENTAL

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Tobacco Quitline

4 weeks, Patch + Lozenge, QuitLine

EXPERIMENTAL

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Drug: 4 weeks of Nicotine lozengeBehavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch, QuitLine

EXPERIMENTAL

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Behavioral: Tobacco QuitlineDrug: 4 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch + Lozenge, SmokeFree Txt

EXPERIMENTAL

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.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Smokefree TXTDrug: 8 Weeks Nicotine Lozenge

8 weeks, Patch, SmokeFree Txt

EXPERIMENTAL

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Drug: 8 weeks of Nicotine Replacement Therapy PatchBehavioral: Smokefree TXT

4 weeks, Patch + Lozenge, SmokeFree Txt

EXPERIMENTAL

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.

Drug: 4 weeks of Nicotine lozengeBehavioral: Smokefree TXTDrug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch, SmokeFree Txt

EXPERIMENTAL

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Behavioral: Smokefree TXTDrug: 4 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch + Lozenge

EXPERIMENTAL

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Drug: 8 weeks of Nicotine Replacement Therapy PatchDrug: 8 Weeks Nicotine Lozenge

8 weeks, Patch

EXPERIMENTAL

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Drug: 8 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch + Lozenge

EXPERIMENTAL

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Drug: 4 weeks of Nicotine lozengeDrug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch

EXPERIMENTAL

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Interventions

4 weeks of Nicotine lozengeDRUG

All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 4 weeks of lozenge in addition to the NRT Patch. 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
4 weeks, Patch + Lozenge4 weeks, Patch + Lozenge, QuitLine4 weeks, Patch + Lozenge, SmokeFree Txt4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch + LozengeQuitAid, 4 weeks, Patch + Lozenge, QuitLineQuitAid, 4 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine
8 weeks of Nicotine Replacement Therapy PatchDRUG

All participants will receive at least 4 weeks of the NRT Patch. Some will also be randomized to receive an additional 4 weeks of the NRT Patch

Also known as: Habitrol Transdermal Product, Pixotine Transdermal Product, Lucy Transdermal Product, Nicoderm C-Q Transdermal Product, Nicotrol Transdermal Product
8 weeks, Patch8 weeks, Patch + Lozenge8 weeks, Patch + Lozenge, QuitLine8 weeks, Patch + Lozenge, SmokeFree Txt8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine8 weeks, Patch, QuitLine8 weeks, Patch, SmokeFree Txt8 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 8 weeks, PatchQuitAid, 8 weeks, Patch + LozengeQuitAid, 8 weeks, Patch + Lozenge, QuitLineQuitAid, 8 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch, QuitLineQuitAid, 8 weeks, Patch, SmokeFree TxtQuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine
QuitAidBEHAVIORAL

All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive the QuitAid intervention, based on a medication adherence intervention, 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.

Also known as: Medication Therapy Management (MTM)
QuitAid, 4 weeks, PatchQuitAid, 4 weeks, Patch + LozengeQuitAid, 4 weeks, Patch + Lozenge, QuitLineQuitAid, 4 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch, QuitLineQuitAid, 4 weeks, Patch, SmokeFree TxtQuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 8 weeks, PatchQuitAid, 8 weeks, Patch + LozengeQuitAid, 8 weeks, Patch + Lozenge, QuitLineQuitAid, 8 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch, QuitLineQuitAid, 8 weeks, Patch, SmokeFree TxtQuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine
Smokefree TXTBEHAVIORAL

All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to 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.

4 weeks, Patch + Lozenge, SmokeFree Txt4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine4 weeks, Patch, SmokeFree Txt4 weeks, Patch, SmokeFree Txt, QuitLine8 weeks, Patch + Lozenge, SmokeFree Txt8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine8 weeks, Patch, SmokeFree Txt8 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch, SmokeFree TxtQuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch, SmokeFree TxtQuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine
Tobacco QuitlineBEHAVIORAL

All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive a 4-session proactive tobacco quitline, with each session lasting 20-30 minutes and occurring on days 7, 14, 21 and 28.The quitline intervention incorporates 3 phases: (1) preparing to quit, (2) quitting process, and (3) relapse prevention.

4 weeks, Patch + Lozenge, QuitLine4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine4 weeks, Patch, QuitLine4 weeks, Patch, SmokeFree Txt, QuitLine8 weeks, Patch + Lozenge, QuitLine8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine8 weeks, Patch, QuitLine8 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch + Lozenge, QuitLineQuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch, QuitLineQuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch + Lozenge, QuitLineQuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch, QuitLineQuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine
4 weeks of Nicotine Replacement Therapy PatchDRUG

All participants will receive at least 4 weeks of the NRT Patch.

Also known as: Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal Product, Habitrol Transdermal Product
4 weeks, Patch4 weeks, Patch + Lozenge4 weeks, Patch + Lozenge, QuitLine4 weeks, Patch + Lozenge, SmokeFree Txt4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine4 weeks, Patch, QuitLine4 weeks, Patch, SmokeFree Txt4 weeks, Patch, SmokeFree Txt, QuitLineQuitAid, 4 weeks, PatchQuitAid, 4 weeks, Patch + LozengeQuitAid, 4 weeks, Patch + Lozenge, QuitLineQuitAid, 4 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 4 weeks, Patch, QuitLineQuitAid, 4 weeks, Patch, SmokeFree TxtQuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine
8 Weeks Nicotine LozengeDRUG

All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 8 weeks of lozenge in addition to the NRT Patch. 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
8 weeks, Patch + Lozenge8 weeks, Patch + Lozenge, QuitLine8 weeks, Patch + Lozenge, SmokeFree Txt8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineQuitAid, 8 weeks, Patch + LozengeQuitAid, 8 weeks, Patch + Lozenge, QuitLineQuitAid, 8 weeks, Patch + Lozenge, SmokeFree TxtQuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

Eligibility Criteria

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

You may qualify if:

  • must be 18 years of age and older
  • must be able to read, speak, and understand English
  • must report smoking at least 5 cigarettes per day for the past 6 months (regardless of non-cigarette tobacco product use)
  • must be willing to set a quit date within the next 30 days
  • must own a cell phone
  • must 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:

  • are pregnant women (self-reported), breastfeeding, planning to become pregnant during the next 6 months
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Related Publications (1)

  • Fahey MC, Krukowski RA, Anderson RT, Cohn WF, Porter KJ, Reid T, Wiseman KP, You W, Wood CH, Rucker TW, Little MA. Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment. Contemp Clin Trials. 2023 Nov;134:107335. doi: 10.1016/j.cct.2023.107335. Epub 2023 Sep 18.

    PMID: 37730197DERIVED

MeSH Terms

Conditions

Smoking CessationCigarette SmokingSmoking ReductionSmokingTobacco Smoking

Interventions

Tobacco Use Cessation DevicesMedication Therapy Management

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

TherapeuticsPharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services Administration

Study Officials

  • Melissa Little, PhD, MPH

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Little, PhD, MPH

CONTACT

434-924-1935mal7uj@virginia.edu

Leslie Gladney, MA

CONTACT

lag3z@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2x2x2x2x2
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

March 6, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No plans to share data at the individual level

Locations

US(1)