Smoking CessationNCT05660525
Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
A study testing 4 weeks of Nicotine lozenge, 8 weeks of Nicotine Replacement Therapy Patch and QuitAid in people with Smoking Cessation and Smoking, Cigarette, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette, Smoking Reduction
- What is being tested?
- 4 weeks of Nicotine lozenge, 8 weeks of Nicotine Replacement Therapy Patch and QuitAid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leslie Gladney, MA contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Melissa A Little, PhD, 4349241935, mal7uj@virginia.edu
About this study
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:
Read more
- 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
Read the 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).
- Conditions
- Smoking Cessation, Smoking, Cigarette, Smoking Reduction, Smoking, Smoking, Tobacco, Quitting Smoking
- Being tested
- 4 weeks of Nicotine lozenge, 8 weeks of Nicotine Replacement Therapy Patch, QuitAid, Smokefree TXT, Tobacco Quitline
- Medical subject headings
- Smoking Cessation, Cigarette Smoking, Smoking Reduction, Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 weeks of Nicotine lozengeDrug
Also called Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette 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 PatchDrug
Also called Habitrol Transdermal Product, Pixotine Transdermal Product, Lucy Transdermal Product, Nicoderm C-Q Transdermal Product
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
QuitAidBehavioural
Also called Medication Therapy Management (MTM)
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 TXTBehavioural
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 QuitlineBehavioural
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 PatchDrug
Also called Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal Product
All participants will receive at least 4 weeks of the NRT Patch.
8 Weeks Nicotine LozengeDrug
Also called Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: QuitAid; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Drug: 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 Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: QuitAid; Behavioral: Tobacco Quitline; Drug: 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 Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: Tobacco Quitline; Drug: 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. Receives: Behavioral: QuitAid; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: 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 Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: 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 Receives: Behavioral: QuitAid; Behavioral: Tobacco Quitline; Drug: 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. Receives: Behavioral: QuitAid; Behavioral: Smokefree TXT; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: Smokefree TXT; Drug: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: QuitAid; Behavioral: Smokefree TXT; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: QuitAid; Behavioral: Smokefree TXT; Behavioral: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: QuitAid; Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Behavioral: QuitAid; Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: Smokefree TXT; Behavioral: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Behavioral: Smokefree TXT; Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: Tobacco Quitline; Drug: 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. Receives: Behavioral: Tobacco Quitline; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: Smokefree TXT; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Behavioral: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Behavioral: Smokefree TXT; Drug: 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. Receives: Behavioral: Smokefree TXT; Drug: 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. Receives: Drug: 8 weeks of Nicotine Replacement Therapy Patch; Drug: 8 Weeks Nicotine Lozenge |
| 8 weeks, Patch | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. Receives: 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. Receives: Drug: 4 weeks of Nicotine lozenge; Drug: 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. Receives: Drug: 4 weeks of Nicotine Replacement Therapy Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Self-Reported Tobacco Abstinence
Self-reported point prevalence abstinence defined as no smoking (even a puff) within the past 7 days
Measured: 1, 2, and 3 months
Adherence to assigned treatment components
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.
Measured: 1, 2, and 3 months
Quit Attempts
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)
Measured: 1, 2, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start6 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2x2x2
- Masking
- None (open label)
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Melissa Little, PhD, MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660525
- Sponsor's protocol ID
- HSR220197
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share data at the individual level
Publications
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.
PubMed 37730197
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
- ClinicalTrials.gov ID
- NCT05660525
- Acronym / sponsor ID
- HSR220197
- Conditions
- Smoking Cessation, Smoking, Cigarette, Smoking Reduction, Smoking, Smoking, Tobacco, Quitting Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 32
- Model description
- 2x2x2x2x2
| Arm | Type | Receives |
|---|---|---|
| QuitAid, 4 weeks, Patch + Lozenge | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: QuitAid, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: QuitAid, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Tobacco Quitline, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Behavioral: QuitAid, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAidSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Tobacco QuitlineSmoking 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 | Experimental | Behavioral: QuitAid, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Behavioral: QuitAid, Behavioral: Smokefree TXT, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Smokefree TXTSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Smokefree TXT, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: QuitAid, Behavioral: Smokefree TXT, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: QuitAid, Behavioral: Smokefree TXT, Behavioral: Tobacco QuitlineSmoking 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 | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: QuitAid, Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Behavioral: QuitAid, Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Smokefree TXT, Behavioral: Tobacco QuitlineSmoking 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 | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Behavioral: Smokefree TXT, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Tobacco Quitline, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Tobacco QuitlineSmoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention. |
| 4 weeks, Patch + Lozenge, QuitLine | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention. |
| 4 weeks, Patch, QuitLine | Experimental | Behavioral: Tobacco Quitline, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Smokefree TXT, Drug: 8 Weeks Nicotine LozengeSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Behavioral: Smokefree TXTSmoking 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 | Experimental | Drug: 4 weeks of Nicotine lozenge, Behavioral: Smokefree TXT, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Behavioral: Smokefree TXT, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking 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 | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy Patch, Drug: 8 Weeks Nicotine LozengeSmoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge. |
| 8 weeks, Patch | Experimental | Drug: 8 weeks of Nicotine Replacement Therapy PatchSmoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
| 4 weeks, Patch + Lozenge | Experimental | Drug: 4 weeks of Nicotine lozenge, Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge. |
| 4 weeks, Patch | Experimental | Drug: 4 weeks of Nicotine Replacement Therapy PatchSmoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 weeks of Nicotine lozengeAlso: Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette LozengeAll 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. | Drug | 4 weeks, Patch + Lozenge, 4 weeks, Patch + Lozenge, QuitLine, 4 weeks, Patch + Lozenge, SmokeFree Txt, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, QuitAid, 4 weeks, Patch + Lozenge, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine |
| 8 weeks of Nicotine Replacement Therapy PatchAlso: Habitrol Transdermal Product, Pixotine Transdermal Product, Lucy Transdermal Product, Nicoderm C-Q Transdermal ProductAll 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 | Drug | 8 weeks, Patch, 8 weeks, Patch + Lozenge, 8 weeks, Patch + Lozenge, QuitLine, 8 weeks, Patch + Lozenge, SmokeFree Txt, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 8 weeks, Patch, QuitLine, 8 weeks, Patch, SmokeFree Txt, 8 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, QuitAid, 8 weeks, Patch + Lozenge, QuitAid, 8 weeks, Patch + Lozenge, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, QuitLine, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine |
| QuitAidAlso: Medication Therapy Management (MTM)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. | Behavioural | QuitAid, 4 weeks, Patch, QuitAid, 4 weeks, Patch + Lozenge, QuitAid, 4 weeks, Patch + Lozenge, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch, QuitLine, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, QuitAid, 8 weeks, Patch + Lozenge, QuitAid, 8 weeks, Patch + Lozenge, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, QuitLine, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine |
| Smokefree TXTAll 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. | Behavioural | 4 weeks, Patch + Lozenge, SmokeFree Txt, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 4 weeks, Patch, SmokeFree Txt, 4 weeks, Patch, SmokeFree Txt, QuitLine, 8 weeks, Patch + Lozenge, SmokeFree Txt, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 8 weeks, Patch, SmokeFree Txt, 8 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine |
| Tobacco QuitlineAll 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. | Behavioural | 4 weeks, Patch + Lozenge, QuitLine, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 4 weeks, Patch, QuitLine, 4 weeks, Patch, SmokeFree Txt, QuitLine, 8 weeks, Patch + Lozenge, QuitLine, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 8 weeks, Patch, QuitLine, 8 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch, QuitLine, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch, QuitLine, QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine |
| 4 weeks of Nicotine Replacement Therapy PatchAlso: Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal ProductAll participants will receive at least 4 weeks of the NRT Patch. | Drug | 4 weeks, Patch, 4 weeks, Patch + Lozenge, 4 weeks, Patch + Lozenge, QuitLine, 4 weeks, Patch + Lozenge, SmokeFree Txt, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, 4 weeks, Patch, QuitLine, 4 weeks, Patch, SmokeFree Txt, 4 weeks, Patch, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch, QuitAid, 4 weeks, Patch + Lozenge, QuitAid, 4 weeks, Patch + Lozenge, QuitLine, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 4 weeks, Patch, QuitLine, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine |
| 8 Weeks Nicotine LozengeAlso: Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette LozengeAll 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. | Drug | 8 weeks, Patch + Lozenge, 8 weeks, Patch + Lozenge, QuitLine, 8 weeks, Patch + Lozenge, SmokeFree Txt, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, QuitAid, 8 weeks, Patch + Lozenge, QuitLine, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine |
Primary outcome
Tobacco Abstinence
Time frame: 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.
3 secondary outcomes
Self-Reported Tobacco Abstinence
Time frame: 1, 2, and 3 months
Adherence to assigned treatment components
Time frame: 1, 2, and 3 months
Quit Attempts
Time frame: 1, 2, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 37730197Fahey 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.
- Individual participant dataSharing planned: No. No plans to share data at the individual level
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leslie Gladney, MA contact
Melissa Little, PhD, MPH principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 weeks of Nicotine lozenge, 8 weeks of Nicotine Replacement Therapy Patch and QuitAid in people with Smoking Cessation and Smoking, Cigarette, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Little, PhD, MPH (434-924-1935, mal7uj@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.