Recruiting

Smoking Cessation

Sponsor:

University of Virginia

Code:

NCT05660525

Conditions

Smoking Cessation

Smoking, Cigarette

Smoking Reduction

Smoking

Smoking, Tobacco

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

4 weeks of Nicotine lozenge

8 weeks of Nicotine Replacement Therapy Patch

QuitAid

Smokefree TXT

Tobacco Quitline

Study Details

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

Conditions

Smoking Cessation

Smoking, Cigarette

Smoking Reduction

Smoking

Smoking, Tobacco

Study ID

NCT05660525

Start date

Mar 6, 2024

Status verified date

Apr, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study participants will be rural cigarette smokers from Virginia, Tennessee, Kentucky and North Carolina who visit one of the participating study pharmacies. Pharmacies will be located in rural geographic areas of the Central and South Central subregions of Appalachia that include Virginia, Tennessee, Kentucky and North Carolina, as defined by the USDA Rural-Urban Continuum Codes (RUCC) 4-9, Rural-Urban Commuting Area (RUCA) codes 4-10, or Frontier and Remote (FAR) areas level 4. No exclusionary criteria are based on race, gender, or age.

Inclusion Criteria include:

  • 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.

Exclusion Criteria include:

  • 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)

Study Design

Enrollment

768 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QuitAid, 4 weeks, Patch + 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.

experimental: QuitAid, 8 weeks, Patch + 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.

experimental: QuitAid, 4 weeks, Patch + Lozenge, 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

experimental: QuitAid, 8 weeks, Patch + Lozenge, 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

experimental: QuitAid, 4 weeks, 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.

experimental: QuitAid, 8 weeks, 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.

experimental: QuitAid, 8 weeks, Patch, 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

experimental: QuitAid, 4 weeks, Patch, 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

experimental: QuitAid, 4 weeks, Patch, 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.

experimental: QuitAid, 8 weeks, Patch, 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.

experimental: QuitAid, 8 weeks, Patch + Lozenge, 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.

experimental: QuitAid, 4 weeks, Patch + Lozenge, 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.

experimental: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, 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.

experimental: QuitAid, 8 weeks, Patch, SmokeFree Txt, 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.

experimental: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, 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.

experimental: QuitAid, 4 weeks, Patch, SmokeFree Txt, 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.

experimental: 8 weeks, Patch + Lozenge, SmokeFree Txt, 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.

experimental: 8 weeks, Patch, SmokeFree Txt, 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.

experimental: 4 weeks, Patch + Lozenge, SmokeFree Txt, 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.

experimental: 4 weeks, Patch, SmokeFree Txt, 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.

experimental: 8 weeks, Patch + Lozenge, QuitLine

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

experimental: 8 weeks, Patch, QuitLine

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

experimental: 4 weeks, Patch + Lozenge, QuitLine

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

experimental: 4 weeks, Patch, QuitLine

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

experimental: 8 weeks, Patch + Lozenge, 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.

experimental: 8 weeks, Patch, 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.

experimental: 4 weeks, Patch + Lozenge, 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.

experimental: 4 weeks, Patch, 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.

experimental: 8 weeks, Patch + Lozenge

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

experimental: 8 weeks, Patch

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

experimental: 4 weeks, Patch + Lozenge

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

experimental: 4 weeks, Patch

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

Interventions

4 weeks of Nicotine lozenge

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.

8 weeks of Nicotine Replacement Therapy Patch

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

QuitAid

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.

Smokefree TXT

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.

Tobacco Quitline

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 of Nicotine Replacement Therapy Patch

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

8 Weeks Nicotine Lozenge

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.

Primary outcome measure

  • Tobacco Abstinence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Melissa Little, PhD, MPH

434-924-1935mal7uj@virginia.edu

Leslie Gladney, MA

lag3z@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

Contacts

Melissa A Little, PhD

4349241935mal7uj@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-04-20.