Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid

Starting soon · Not applicable

Conditions studied: Tobacco Use Cessation, Tobacco Use Disorder, Nicotine Dependence, Smokeless Tobacco Use

In brief

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.

Key facts

Study ID

NCT07694492

Run by

University of Virginia

People needed

120

Starts

2026-09-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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