Tobacco Use CessationNCT07694492
Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid
A study testing QuitAid (pharmacist-delivered MTM) and Nicotine Replacement Therapy (NRT) in people with Tobacco Use Cessation and Tobacco Use Disorder, run by University of Virginia at 1 site in United States.
Trial summary
Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Use Disorder, Nicotine Dependence
- What is being tested?
- QuitAid (pharmacist-delivered MTM) and Nicotine Replacement Therapy (NRT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2027
- 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
- Age ≥ 18 years
- Able to read, speak, and understand English
- A coal miner who uses tobacco and nicotine products, lives in the U.S., and has a current black-lung workers' compensation case with a participating law office
- Reports using tobacco and nicotine products daily for the past 6 months
- Willing and able to use NRT in the form of patch or gum
- Not pregnant or planning to become pregnant in the next 6 months
Who cannot join
- Medical contraindication to NRT (e.g., within the past 30 days: heart attack or stroke; within the past 6 months: serious or worsening angina, or very rapid or irregular heartbeat requiring medication)
- Pregnant or breastfeeding, or planning to become pregnant during the next 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Ashley N DeMoss, MPH, (304) 574-8073, fzv3nn@virginia.edu
Melissa A Little, PhD, MPH
About this study
Official title: Determining the Feasibility of Utilizing a Medical-Legal Partnership Model to Reach Coal Miners Who Use Tobacco and Nicotine Products and Connect Them to a Pharmacy-based Cessation Program
Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). This study tests a novel medical-legal partnership (MLP) that "flips" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.
Read the detailed description
Background and rationale. Lung cancer rates are approximately 25% higher in Central Appalachia than in the rest of the U.S., and black-lung mortality has been markedly elevated in the region. Coal miners report the highest rates of cigarette smoking (about 23% vs. ~14% nationally) and smokeless tobacco use (about 23% vs. ~3% nationally) of any U.S. occupation, and TNP use magnifies the risk and severity of obstructive lung disease and lung cancer in this already high-risk group. National guidelines recommend that clinicians refer TNP users to cessation services via ask-advise-connect, but time constraints, limited provider buy-in, and patient factors limit adoption. In workers' compensation cases, claimants must prove their disease results from coal-dust exposure rather than TNP use, which creates both a health and a financial incentive for cessation and gives the miner-lawyer relationship unusual salience. This study leverages that relationship by having lawyers ask about TNP use (already routine at intake), advise quitting, and connect interested clients to a pharmacist-delivered cessation program (the novel component). QuitAid, previously developed and piloted by the study team, is a pharmacist-delivered MTM intervention designed to increase NRT adherence and promote cessation.
Aim 1 (implementation evaluation, lawyers). Guided by the Consolidated Framework for Implementation Research (CFIR), the team evaluates facilitators and barriers to adopting the ask-advise-connect model in approximately three black-lung law offices. Lawyers (up to 5 enrolled) complete baseline and follow-up surveys assessing self-efficacy, attitudes, and perceived facilitators/barriers, and participate in ~30-minute semi-structured telephone interviews (audio-recorded, analyzed thematically). Recruitment feasibility is measured by the proportion of coal miners referred per office and the number enrolled per month. Lawyers are study participants only, not investigators, and referral has no effect on a miner's legal case.
Aim 2 (randomized feasibility pilot, coal miners). Coal miners who use TNPs and have a current black-lung workers' compensation case with a participating law office are referred, screened, and consented by phone, complete a baseline assessment, and are then randomized 1:1 via computer-generated permuted-block randomization (generated in R, embedded in REDCap) to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT beginning in Week 1 regardless of readiness to quit. Participants use of smoked TNPs (cigarettes, e-cigarettes, little cigars, cigarillos, cigars) receive the long-acting NRT patch; those using oral TNPs (smokeless tobacco, nicotine pouches) receive short-acting NRT gum; those using both receive the patch. Participants randomized to QuitAid who are ready to quit receive six telephonic pharmacist coaching sessions over 4 weeks; those not ready to quit receive up to three telephonic Pre-Quit Motivation Modules and may transition to QuitAid if they report readiness at any weekly check-in during Weeks 1-4. If readiness is not reported after four weekly check-ins, QuitAid ends. Follow-up assessments are conducted with all participants at 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks via secure REDCap links or telephone. Because this is a feasibility pilot, secondary clinical outcomes are analyzed descriptively and with logistic regression only to inform a future full-scale trial.
- Being tested
- QuitAid (pharmacist-delivered MTM), Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking Cessation, Lawyers, medical-legal partnership;, ask-advise-connect, pharmacist-delivered intervention, coal miners, medication therapy management (MTM), nicotine replacement therapy, QuitAid, tobacco and nicotine products, Central Appalachia, black lung, workers' compensation, feasibility pilot
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use Disorder, Smoking Cessation, Anthracosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitAid (pharmacist-delivered MTM)Behavioural
Also called Medication Therapy Management (MTM)
Six telephonic pharmacist coaching sessions over 4 weeks focused on setting a quit date and quitting TNPs. The first session (and subsequent proactive calls at ~days 2, 7, 14, 21, and 28) addresses negative beliefs about NRT, strengthens motivation and commitment to NRT use, monitors NRT use, provides feedback, and supports adherence. Includes the Pre-Quit Motivation Modules (up to three telephonic sessions) for participants not yet ready to quit.
Nicotine Replacement Therapy (NRT)Drug
24 weeks of NRT dispensed under a standing order and mailed to participants, with standard use guidelines. Product is matched to TNP type: long-acting patch for smoked TNP users, short-acting gum for oral TNP users, patch for dual users.
| Study group | Role | What they receive |
|---|---|---|
| QuitAid + NRT | Experimental | Participants receive the pharmacist-delivered QuitAid MTM program plus 24 weeks of NRT. Those ready to quit receive six telephonic coaching sessions over 4 weeks; those not ready to quit receive up to three Pre-Quit Motivation Modules and may transition to QuitAid upon reporting readiness at a weekly check-in (Weeks 1-4). Receives: Behavioral: QuitAid (pharmacist-delivered MTM); Drug: Nicotine Replacement Therapy (NRT) |
| NRT Only | Active comparator | Participants receive 24 weeks of NRT beginning in Week 1 without the QuitAid MTM program. All follow-up assessments are conducted regardless of condition. Receives: Drug: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Randomization
Number of coal miners who need to be approached and screened in order to randomize 100 TNP users.
Measured: Through study recruitment (approximately 6 months)
Retention
Proportion of randomized coal miners who complete the 26-week follow-up visit.
Measured: 26 weeks
Fidelity of Implementation
Fidelity of QuitAid delivery, assessed as adherence to QuitAid, quality of program delivery, participant responsiveness, and program differentiation, captured via a session checklist and self-reported end-of-session reflections.
Measured: Through the 4-week intervention period
Dose of the Medication Therapy Management (MTM) Intervention
Number of MTM (QuitAid) sessions received per participant, documented in the REDCap database.
Measured: Through the 4-week intervention period
Dose of NRT
Reported proportion of provided NRT that was used by participants.
Measured: Baseline through 26 weeks
Secondary outcomes (6)
Self-Reported Tobacco Abstinence
Self-reported abstinence, defined as no use of any tobacco or nicotine products within the past 7 days.
Measured: 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks
Quit Attempts
Number of quit attempts since the previous contact, where a quit attempt is abstinence for ≥24 hours not due to involuntary or forced cessation (e.g., hospitalization).
Measured: Baseline through 26 weeks
Frequency of Urges to Use TNPs
Self-reported frequency of urges to use tobacco/nicotine products.
Measured: Baseline through 26 weeks
Adherence to Assigned Treatment(s)
Percentage of intervention sessions completed and percentage of provided NRT used.
Measured: Baseline through 26 weeks
Adherence to NRT
Adherence to NRT (patch or gum), measured as the percentage of provided NRT used.
Measured: Baseline through 26 weeks
Strength of urges to use TNPs
Self-reported strength of urges to use tobacco/nicotine products.
Measured: Baseline through 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use 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
- Parallel groups
- Model description
- Two-arm randomized feasibility pilot. Participants are randomized 1:1 to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT. The trial is a feasibility pilot and is not powered to detect between-arm differences; primary outcomes are process/feasibility measures.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Melissa A Little, PhD, MPH, Principal investigator, University of VirginiaDrew Harris, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694492
- Sponsor's protocol ID
- HSR 303071
- Other IDs
- 5P30CA044579-30
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Utilizing a Medical-Legal Partnership Model to Reach Coal Miners Who Use Tobacco and Nicotine Products and Connect Them to a Pharmacy-based Cessation Program
- ClinicalTrials.gov ID
- NCT07694492
- Acronym / sponsor ID
- HSR 303071
- Keywords
- Smoking Cessation, Lawyers, medical-legal partnership;, ask-advise-connect, pharmacist-delivered intervention, coal miners, medication therapy management (MTM), nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2026 (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.
Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). This study tests a novel medical-legal partnership (MLP) that "flips" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.
Detailed description
Background and rationale. Lung cancer rates are approximately 25% higher in Central Appalachia than in the rest of the U.S., and black-lung mortality has been markedly elevated in the region. Coal miners report the highest rates of cigarette smoking (about 23% vs. ~14% nationally) and smokeless tobacco use (about 23% vs. ~3% nationally) of any U.S. occupation, and TNP use magnifies the risk and severity of obstructive lung disease and lung cancer in this already high-risk group. National guidelines recommend that clinicians refer TNP users to cessation services via ask-advise-connect, but time constraints, limited provider buy-in, and patient factors limit adoption. In workers' compensation cases, claimants must prove their disease results from coal-dust exposure rather than TNP use, which creates both a health and a financial incentive for cessation and gives the miner-lawyer relationship unusual salience. This study leverages that relationship by having lawyers ask about TNP use (already routine at intake), advise quitting, and connect interested clients to a pharmacist-delivered cessation program (the novel component). QuitAid, previously developed and piloted by the study team, is a pharmacist-delivered MTM intervention designed to increase NRT adherence and promote cessation.
Aim 1 (implementation evaluation, lawyers). Guided by the Consolidated Framework for Implementation Research (CFIR), the team evaluates facilitators and barriers to adopting the ask-advise-connect model in approximately three black-lung law offices. Lawyers (up to 5 enrolled) complete baseline and follow-up surveys assessing self-efficacy, attitudes, and perceived facilitators/barriers, and participate in ~30-minute semi-structured telephone interviews (audio-recorded, analyzed thematically). Recruitment feasibility is measured by the proportion of coal miners referred per office and the number enrolled per month. Lawyers are study participants only, not investigators, and referral has no effect on a miner's legal case.
Aim 2 (randomized feasibility pilot, coal miners). Coal miners who use TNPs and have a current black-lung workers' compensation case with a participating law office are referred, screened, and consented by phone, complete a baseline assessment, and are then randomized 1:1 via computer-generated permuted-block randomization (generated in R, embedded in REDCap) to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT beginning in Week 1 regardless of readiness to quit. Participants use of smoked TNPs (cigarettes, e-cigarettes, little cigars, cigarillos, cigars) receive the long-acting NRT patch; those using oral TNPs (smokeless tobacco, nicotine pouches) receive short-acting NRT gum; those using both receive the patch. Participants randomized to QuitAid who are ready to quit receive six telephonic pharmacist coaching sessions over 4 weeks; those not ready to quit receive up to three telephonic Pre-Quit Motivation Modules and may transition to QuitAid if they report readiness at any weekly check-in during Weeks 1-4. If readiness is not reported after four weekly check-ins, QuitAid ends. Follow-up assessments are conducted with all participants at 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks via secure REDCap links or telephone. Because this is a feasibility pilot, secondary clinical outcomes are analyzed descriptively and with logistic regression only to inform a future full-scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized feasibility pilot. Participants are randomized 1:1 to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT. The trial is a feasibility pilot and is not powered to detect between-arm differences; primary outcomes are process/feasibility measures.
| Arm | Type | Receives |
|---|---|---|
| QuitAid + NRT | Experimental | Behavioral: QuitAid (pharmacist-delivered MTM), Drug: Nicotine Replacement Therapy (NRT)Participants receive the pharmacist-delivered QuitAid MTM program plus 24 weeks of NRT. Those ready to quit receive six telephonic coaching sessions over 4 weeks; those not ready to quit receive up to three Pre-Quit Motivation Modules and may transition to QuitAid upon reporting readiness at a weekly check-in (Weeks 1-4). |
| NRT Only | Active comparator | Drug: Nicotine Replacement Therapy (NRT)Participants receive 24 weeks of NRT beginning in Week 1 without the QuitAid MTM program. All follow-up assessments are conducted regardless of condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Able to read, speak, and understand English
- A coal miner who uses tobacco and nicotine products, lives in the U.S., and has a current black-lung workers' compensation case with a participating law office
- Reports using tobacco and nicotine products daily for the past 6 months
- Willing and able to use NRT in the form of patch or gum
Key exclusion criteria (2 listed)
- Medical contraindication to NRT (e.g., within the past 30 days: heart attack or stroke; within the past 6 months: serious or worsening angina, or very rapid or irregular heartbeat requiring medication)
- Pregnant or breastfeeding, or planning to become pregnant during the next 6 months
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 |
|---|---|---|
| QuitAid (pharmacist-delivered MTM)Also: Medication Therapy Management (MTM)Six telephonic pharmacist coaching sessions over 4 weeks focused on setting a quit date and quitting TNPs. The first session (and subsequent proactive calls at ~days 2, 7, 14, 21, and 28) addresses negative beliefs about NRT, strengthens motivation and commitment to NRT use, monitors NRT use, provides feedback, and supports adherence. Includes the Pre-Quit Motivation Modules (up to three telephonic sessions) for participants not yet ready to quit. | Behavioural | QuitAid + NRT |
| Nicotine Replacement Therapy (NRT)24 weeks of NRT dispensed under a standing order and mailed to participants, with standard use guidelines. Product is matched to TNP type: long-acting patch for smoked TNP users, short-acting gum for oral TNP users, patch for dual users. | Drug | NRT Only, QuitAid + NRT |
Primary outcome
Feasibility of Randomization
Time frame: Through study recruitment (approximately 6 months)
Number of coal miners who need to be approached and screened in order to randomize 100 TNP users.
Retention
Time frame: 26 weeks
Proportion of randomized coal miners who complete the 26-week follow-up visit.
Fidelity of Implementation
Time frame: Through the 4-week intervention period
Fidelity of QuitAid delivery, assessed as adherence to QuitAid, quality of program delivery, participant responsiveness, and program differentiation, captured via a session checklist and self-reported end-of-session reflections.
Dose of the Medication Therapy Management (MTM) Intervention
Time frame: Through the 4-week intervention period
Number of MTM (QuitAid) sessions received per participant, documented in the REDCap database.
Dose of NRT
Time frame: Baseline through 26 weeks
Reported proportion of provided NRT that was used by participants.
6 secondary outcomes
Self-Reported Tobacco Abstinence
Time frame: 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks
Quit Attempts
Time frame: Baseline through 26 weeks
Frequency of Urges to Use TNPs
Time frame: Baseline through 26 weeks
Adherence to Assigned Treatment(s)
Time frame: Baseline through 26 weeks
Adherence to NRT
Time frame: Baseline through 26 weeks
Strength of urges to use TNPs
Time frame: Baseline through 26 weeks
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 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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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.
Melissa A Little, PhD, MPH principal investigator
University of Virginia
Drew Harris, MD 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 QuitAid (pharmacist-delivered MTM) and Nicotine Replacement Therapy (NRT) in people with Tobacco Use Cessation and Tobacco Use Disorder, 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 6 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: opening soon, as of the sponsor's last update on 10 Jul 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 Ashley N DeMoss, MPH ((304) 574-8073, fzv3nn@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Randomization (time frame: Through study recruitment (approximately 6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.